standard summary project fiche · the project purpose is to ensure effective and reliable liquid...

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Standard Summary Project Fiche

1. Basic InformationCRIS Number: BG2003/004-937.02.011.1 Title: Strengthening of the administrative and measurement capacity for enforcement of

legislation on liquid fuels and measuring medical devices. Strengthening of the nationalthermophysics measurement capacity.

1.2 Sector:1.3 Location: The Republic of Bulgaria

2. Objectives

2.1 Overall Objective(s):• Enforcement of the acquis related to liquid fuels quality control and a national liquid

fuels quality monitoring system in order to ensure environmental protection ;

• Enforcement of the acquis related to measuring systems for liquids other than water;

• Ensuring metrological control of measuring instruments used in health care;

• Establishing international recognition of temperature and effected measurement resultscreating the technical conditions to respond to the service demand in certain industrysectors.

2.2 Project purpose:The project purpose is to ensure effective and reliable liquid fuels quality control, andproper metrological control of measuring instruments in the field of health care and liquidfuels, and temperature measurements traceability and equivalence, while the specificpurposes are as follows:

• Strengthening the administrative, monitoring and testing capacity for enforcement ofthe acquis related to the field of liquid fuels quality control;

• Strengthening the administrative and technical capacity for enforcement of the acquisrelated to measuring systems for liquids other than water;

• Strengthening the administrative and technical capacity for carrying out metrologicalcontrol of measuring instruments used in health care;

• Establishing state-of-the-art standard laboratory for thermophysics measurements.

2.3 Accession Partnership (AP) and NPAA priority:Priorities defined in the Accession Partnership 2002

Free movement of goods• Implement “New Approach” Directives on the basis of modified framework legislation

and reinforcement of related administrative capacity (conformity assessment bodiesand laboratories).

Environment• Continue implementation of the acquis with particular emphasis on environmental

impact assessment, air quality, waste management, water quality, nature protection,industrial pollution control and risk management, and radiation protection. Continue

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preparation and development of directive-specific implementation plans, includingfinancing plans, with particular emphasis on waste management (including wastemanagement plans), water quality and nature protection, and start implementation.

• Continue strengthening administrative, monitoring and enforcement capacity atnational and regional levels.

Road Map for Bulgaria

The roadmap for Bulgaria prepared by the European Commission in November 2002indicates the main steps that it needs to take to be ready for membership. It covers bothalignment of legislation and development of administrative capacity.Chapter: Free movement of goodsBulgaria should focus further efforts on in particular the development of a nationalconformity assessment system. Negotiations on this chapter are provisionally closed.Attention needs to be given to ensuring commitments made in that process are respected.

Key Medium term steps include:• Complete alignment with the acquis for sector specific legislation for areas covered by

Old Approach Directives.• Strengthen administrative capacity in the field of standardisation and develop

conformity assessment bodies and laboratories.

Chapter: EnvironmentBulgaria should now focus its efforts in particular on environmental impact assessment,waste management, nature protection, industrial pollution and risk management,chemicals and genetically modified organisms, and nuclear safety and radiationprotection. Implementation and enforcement of the acquis in this area continue toconstitute a major challenge for the future, in particular because of the need to increaseadministrative capacity, especially at regional and local level. Bulgaria needs to focus oninvestments, and on reinforcing administrative capacity and implementation within allenvironment sectors, while continuing progress with transposition. Negotiations on thischapter are underway. Attention will need to be given to ensuring that commitments madein that process are respected.

Objectives defined in the National Programme for the Adoption of the Acquis(NPAA) 2002

Free movement of goods• Establishing a national calibration system that will respond to the industry needs and

the conformity assessment system – improvement of the measurement standards basis;• Strengthening the system for metrological control of measuring instruments.

Environment• Full implementation of the acquis in respect to fuel quality;• Adoption of the Ordinance on fuel quality control under the Law on Ambient Clean

Air.

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3. Description

3.1 Background and justification:During the last few years Bulgaria has done significant steps in transposition of theEuropean legislation in the field of free movement of goods and environment. The basiclegislation related to the obligations of the State Agency for Metrology and TechnicalSurveillance (SAMTS) in the fields mentioned is as follows:• Law on Ambient Clean Air;• Law on Measurements;• Law on Technical Requirements to Products.The Law on Ambient Clean Air lays down the general requirements for the air quality, thereduction of the polluting emissions and the rights and obligations of the state and localadministration. By an Ordinance on the requirements to the quality control of liquid fuels,the conditions, procedure and methods of their control Directive 1999/32/EC andDirective 98/70/EC will be transposed in the Bulgarian legislation. The ordinance issubmitted to the Council of Ministers for adoption (for details see Annex 2 – Qualitycontrol of liquid fuels).

The Law on Measurements and relevant secondary legislation transpose the Europeanlegislation in the field of legal metrology and pre-packages. According to this lawmetrological control shall be performed for ensuring accuracy and reliability of themeasurements in healthcare and of the measurements related to public safety, environmentprotection, state and municipal receivables and commercial payments. By an Ordinanceon the requirements to measuring instruments subject to legal control the Europeandirectives on different types of measuring instruments, including on measuring systemsfor liquids other than water (71/319/EEC, 71/348/EEC, 77/313/EEC, 71/318/EEC) arebeing transposed (for details see Annex 2 – Measuring systems other than water).

The Law on Technical Requirements to Products is a framework law. Its priority objectiveis the implementation of the principles under the New Approach and the GlobalApproach. The major part of the New Approach directives is being transposed into theBulgarian legislation as ordinances under this law. Transposition of New Approachlegislation (15 directives transposed by the end of 2002) creates the legal basis for thedevelopment of the relevant conformity assessment system offering services tomanufactures. Transposition of the acquis and implementation infrastructure providesconditions for signing of the Protocols to the Europe Agreement on ConformityAssessment and Acceptance of Industrial Products (PECA), which will guarantee freemovement of industrial goods. The transposition of directives on medical devices(90/385/EEC, 93/42/EEC and 98/79/EEC) is forthcoming (for details see Annex 2 –Measurements in the health sector).

For the implementation of that legislation, the efforts of the administrative authorities arefocused on enforcement of measures through establishing the respective institutionalframework and proper coordination between legal metrology, environment and health careactivities. Those authorities must strengthen their capacity for:• ensuring accuracy, reliability and traceability of measurements carried out in the field

of flow rate measurements and liquid fuels quality;• carrying out metrological control of measuring instruments, including medical devices

with measuring functions and measuring systems for liquids other than water;

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• carrying out quality control of liquid fuels;• establishing a fuel quality monitoring system in order to protect environment;• prevention of false measurement results and frauds in liquid fuels transactions.

Thus the recommendation on institutional strengthening to ensure proper implementationmade in the Regular Report 2002 will be met in the respective fields.

Temperature measurement is one of the most widespread measurements in all fields –industry, health care, ecology, labour safety, fire and explosion safety, transport safety,etc. The accuracy of temperature measurements has direct influence on the measurementaccuracy of all other quantities, such as electrical quantities, length, mass, volume, flowrate (of liquid fuels, gas, thermal energy), pressure, physical chemistry. Currently, theRepublic of Bulgaria does not possess the required equipment for realisation of theInternational Temperature Scale - ITS 1990. The measurement results are not equivalentto those obtained in other countries.Under Phare 2000 Project “Establishing of a conformity assessment system”, sub-projectBG 0003.02.03 “Supply of equipment for metrology” included equipment for thethermophysics measurements laboratory within Directorate General “National Centre ofMetrology” (DG "NCM"). However, the tender for that particular equipment failed andthe tender procedure was cancelled. Since it was impossible to re-tender, due to theimminent end of the contracting period, that supply component is included in this project.

3.2 Linked activities:The ongoing sub-project BG 0003.02.02 “Technical assistance for metrology” underPhare 2000 Project “Establishing of a conformity assessment system”, includesdetermination of mid-term priorities of metrology and elaboration of a long-term strategyfor development of national measurement standards and the infrastructure of calibrationlaboratories, accreditation of laboratories for type examination and calibration ofmeasuring instruments. The implementation of this Phare 2003 project will be in line withthat metrology strategy and will contribute to the establishment of the necessaryimplementation infrastructure in critical fields addressed.

Under the Phare 2000 Project “Establishing of a conformity assessment system”, sub-project BG 0003.02.03 “Supply of equipment for metrology”, measuring equipment forthe chemical measurement standard laboratory within SAMTS DG "NCM", is beingsupplied. The equipment will be used for certification of reference materials for chemicalcomposition of substances and materials, as well as for development and validation ofmethods of chemical composition measurements.The Phare 2002 Project “Strengthening of the national conformity assessment system”,which is under preparation, will provide the necessary capacity for achieving therequirements as regards accuracy, reliability and traceability in the fields of electric,physical and mechanical measurements.

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3.3 Results:The project, consisting of seven components, foresees producing the following results inthe different areas:

Component 1:Technical Assistance for Directorate General “Quality Control of Liquid Fuels” (DG“QCLF”)R1.1 Staff capable to autonomously implement the national liquid fuels quality

monitoring system (FQMS);R1.2 An IT-system for management of data and activities related to liquid fuels quality

control established and customised for the respective application;R1.3 Staff trained to be able to effectively use that IT-system.

Supply of Equipment for Directorate General “Quality Control of Liquid Fuels”R1.4 Equipment for testing liquid fuels quality supplied and operational (see Annex 3);R1.5 IT-system hardware and software supplied and operational (see Annex 3).

Component 2:Technical Assistance for Directorate General “Measures and measuringInstruments” (DG “MMI”) - Flow Rate Measurement LaboratoryR2.1 Analysis with recommendations for improvement of the administrative and

technical capacity for the implementation of New Approach Directive onMeasuring Instruments - Flow rate measuring instruments.

R2.2 Staff trained on implementation of draft New Approach Directive on MeasuringInstruments - Flow rate measuring instruments - and respective WELMECdocuments to be able to carry out the respective measurements;

R2.3 Staff trained on uncertainty budget of the testing procedures;

Supply of Equipment for Directorate General “Measures and MeasuringInstruments” - Flow Rate Measurement LaboratoryR2.4 Fuel flow rate equipment, traceable to internationally recognised measurement

standards, supplied and operational (see Annex 4).

Component 3:Technical Assistance for Directorate General “Measures and MeasuringInstruments” - Laboratories for metrological control of medical devices withmeasuring functionsR3.1 Administrative, technological and technical capacity of laboratories for carrying

out metrological control of measuring instruments used in health care assessed;R3.2 Strategy for development of metrological activities regarding measuring

instruments used in health care after implementation of New Approach MedicalDevices Directive ;

R3.3 Staff trained and able to autonomously carrying out metrological control ofmeasuring instruments used in health care in compliance with European practice.

Supply of Equipment for Directorate General “Measures and MeasuringInstruments” - Laboratories for metrological control of medical devices withmeasuring functions

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R3.4 Equipment for type examination and initial verification of medical devices withmeasuring functions, traceable to internationally recognised measurementstandards, supplied and operational (see Annex 5).

Component 4:Supply of Equipment for Directorate General “National Centre of Metrology” (DG“NCM”) - Thermophysics measurements laboratoryR.4.1 Equipment for Thermophysics measurement laboratory, traceable to

internationally recognised measurement standards, supplied and operational(Annex 6).

3.4 Activities:The following activities are to be implemented under the project:Component 1:Technical Assistance for Directorate General “Quality Control of Liquid Fuels” (DG“QCLF”)A1.1 Staff training on specific technical and operational issues related to

implementation of the liquid fuels quality monitoring system (FQMS);A1.2 Consulting engineering on customising applications and assistance to staff in

putting into operation of a computerised management system for liquid fuelsquality control and related activities;

A1.3 Staff training on use of the IT-system;A1.4 Organisation and participation in international proficiency testing.

Supply of Equipment for Directorate General “Quality Control of Liquid Fuels”A1.5 Procurement of equipment for testing of liquid fuels and its putting into operation;A1.6 Procurement of IT-system hardware and software and their putting into operation.

Component 2:Technical Assistance for Directorate General “Measures and measuringInstruments” (DG “MMI”) - Flow Rate Measurement LaboratoryA2.1 Assessment and preparation of recommendations for improvement of the

administrative and technical capacity for the implementation of New ApproachDirective on Measuring Instruments - Flow rate measuring instruments.

A2.2 Training of staff on implementation of the draft New Approach Directive onMeasuring Instruments - Flow rate measuring instruments - and respectiveWELMEC documents;

A2.3 Training of staff on uncertainty budget of the testing procedures.

Supply of Equipment for Directorate General “Measures and MeasuringInstruments” - Flow Rate Measurement LaboratoryA2.4 Procurement of fuel flow rate equipment, traceable to internationally recognised

measurement standards, and its putting into operation.

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Component 3:Technical Assistance for Directorate General “Measures and MeasuringInstruments” - Laboratories for metrological control of medical devices withmeasuring functionsA3.1 Workshop and introduction of the EU practice in metrological control of

measuring instruments used in health care;A3.2 Assessment of the administrative, technological and technical capacity of

laboratories for carrying out metrological control of measuring instruments used inhealth care;

A3.3 Elaboration of strategy for development of metrological activities regardingmeasuring instruments used in health care after the implementation of NewApproach Medical Devices Directive;

A3.4 Practical training in EU Member States on carrying out metrological control ofmeasuring instruments used in health care.

Supply of Equipment for Directorate General “Measures and MeasuringInstruments” - Laboratories for metrological control of medical devices withmeasuring functionsA3.5 Procurement of equipment for type examination and initial verification of

measuring instruments used in health care, traceable to internationally recognisedmeasurement standards, and its putting into operation.

Component 4:Supply of Equipment for Directorate General “National Centre of Metrology” (DG“NCM”) - Thermophysics measurements laboratoryA.4.1 Procurement of metrology equipment for Thermophysics laboratory, traceable to

international measurement standards, and its putting into operation.

3.5 Lessons learned:During the last years, in order to ensure free movement of industrial goods, SAMTS hasactively worked on transposition and enforcement of the New Approach acquis as well ason establishing the necessary infrastructure. It has gained significant experience in practicalapplication of the European principles on standardisation, certification, accreditation,metrology, technical and market surveillance.

SAMTS has coordinated and participated in the working groups transposing the NewApproach Directives. It has organised workshops and seminars for economic operators,conformity assessment bodies and regulators. SAMTS staff is qualified in the above-mentioned fields by hosting and participation in different professional related activities,training and seminars.

During the last years, SAMTS has gained sufficient experience in programming andimplementation of Phare projects, and their projects implemented have been successful.

4. Institutional Framework

The following is the institutional framework in which the project will have to operate.

The beneficiary of the project is the State Agency for Metrology and Technical Surveillance,which is organised in six directorates general. Three of these directorates, namely the

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Directorate General “Quality Control of Liquid Fuels”, Directorate General “Measures andMeasuring Instruments" and Directorate General “National Centre of Metrology" are directbeneficiaries under the respective project components:• Directorate General “Quality Control of Liquid Fuels” - Component 1: Technical

Assistance for DG “QCLF” and Supply of Equipment for DG “QCLF”The basic obligations of the Directorate General “Quality Control of Liquid Fuels” are tomonitor and control liquid fuels for which quality requirements are laid down in Directive1999/32/EC and Directive 98/70/EC. The Directorate is organised in two units: "Testing ofFuels and Lubricants" Department and three “Quality Control of Liquid Fuels” RegionalDepartments situated throughout the country. The number of their staff is 12 and 18 personsrespectively.

• Directorate General “Measures and Measuring Instruments" - Component 2: TechnicalAssistance for DG “MMI” - Flow Rate Measurement Laboratory, Supply of Equipment forDG “MMI” - Flow Rate Measurement Laboratory, Component 3: Technical Assistance forDG “MMI” - Laboratories for metrological control of medical devices with measuringfunctions and Supply of Equipment for DG “MMI” - Laboratories for metrological controlof medical devices with measuring functionsDirectorate General “Measures and Measuring Instruments” is responsible for legalmetrology activities and performing type examination, initial and subsequent verification ofmeasuring instruments subject to metrological control. The directorate is organised inregional departments all over the country. The total number of staff is 330. Three laboratoriesfor type examination are in process of preparation for accreditation under Phare ProjectBG 0003.02.02 in order to meet requirements of expected CIML Mutual AcceptanceArrangement.

• Directorate General “National Centre of Metrology" - Component 4: Supply ofEquipment for DG “NCM” - Thermophysics measurements laboratoryThe basic obligations of the Directorate General “National Centre of Metrology" are toestablish and develop the national measurement standards, ensure traceability of the nationalmeasurement standards to the international measurement standards or to measurementstandards of Member States of the Meter Convention, disseminate units of measurements,perform calibration and comparisons. The total number of staff is 75. Since 2000, DG“NCM” has participated in the EUROMET activities.

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5. Detailed Budget

Phare Support €Component Investment

SupportInstitutionBuilding

Total Phare(=I+IB)

National*Co-financing

€

IFI TOTAL€

150 000 150 000 - 150 0001825 000 825 000 385 000 - 1 210 000

100 000 100 000 - 100 0002975 000 975 000 455 000 - 1 430 000

150 000 150 000 - 150 0003525 000 525 000 245 000 - 770 000

4 500 000 500 000 167 000 - 667 000Total 2 825 000 400 000 3 225 000 1 252 000 - 4 477 000

*) joint and parallel co-financing, see 11.26. Implementation Arrangements

6.1 Implementing AgencyThe implementing agency is the Central Finance and Contracts Unit (CFCU) in close co-operation with the beneficiary State Agency for Metrology and Technical Surveillance.Contact details of the CFCU:Director of the Central Finance and Contracts UnitMinistry of Finance102 Rakovski St.1040 Sofia, BulgariaPhone: +359-2/9859 2772; 9859 2777; Fax: +359-2/9859 2773E-mail : [email protected]

Contact details for all Components:

President of the State Agency for Metrology and Technical Surveillance21, 6th September Street1000 Sofia, BulgariaPhone: +359-2/989-8488 Fax: +359-2/986-1707E-mail : [email protected]

6.2 TwinningNot applicable

6.3 Non-standard aspectsNot applicable

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6.4 ContractsThe project is expected to be contracted under one service contract and one tenderprocedure for supply, with up to 4 contracts. The estimated contract values are as follows:

Types of contracts Pharesupport

Nationalco-financing

TOTAL€

Service contract (one contract) 400 000 -- 400 000Component 1: TA for Quality control of liquid fuelsComponent 2: TA for flow rateComponent 3: TA for metrological control ofmeasuring instruments used in health care

150 000100 000150 000

------

150 000100 000150 000

Supply contract(s) (up to 4 contracts): 2 825 000 942 000 3 767 000Lot 1: Equipment for quality control of liquid fuelsLot 2: Flow rate measurement equipmentLot 3: Equipment for metrological control of

measuring instruments used in health careLot 4: Equipment for thermophysics laboratory

825 000975 000525 000

500 000

275 000325 000175 000

167 000

1 100 0001 300 000

700 000

667 000Total 3 225 000 942 000 4 167 000

7. Implementation Schedule

7.1 Start of tendering /call for proposals:The Terms of Reference for the components's Technical Assistance and TechnicalSpecifications for supplies will be ready by September 2003.

7.2 Start of project activity:Expected date of commencement of the first contract is 1 April 2004.

7.3 Project completion:Expected date of last payment is October 2006.

8. Equal Opportunity

The management of the beneficiary institutions will ensure that men and women are equallyrepresented in all training measures. For and during all training events, lists of participants willbe established and kept with the project documentation. The issue of women’s participation willhave to be addressed in the progress reports.

9. Environment

The equipment to be procured under all components shall not have any negative impact on theenvironment. Environmental conditions in the laboratory premises will be in compliance withthe requirements of local environmental regulations. The establishment of fuel qualitymonitoring system will also contribute to the protection of human health and environment.

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10. Rates of return

Investment support for the activities carried out, as prescribed by laws, are non-profit oriented.The fees collected by the beneficiaries for those activities cover the operational costs. Thebenefits of investments are further addressed in Annex 2.

11. Investment criteria

11.1 Catalytic effect:In the last few years, some type examination laboratories at SASM were renovated andnew measurement standards were purchased by means of the state budget and Europeanprogrammes (weighing instruments, electric energy meters, water meters). However,considerable financial means are still necessary to establish up-to-date laboratories inother specific sectors, such as medical devices with measuring functions and measuringsystems for liquid fuels. The lack of financial support would lead to a significant delay inthe process of establishment of the necessary implementation infrastructure in the fieldsaddressed, since the economical situation is still too weak to allow for self-financing theestablishing laboratories at EU level.

11.2 Co-financing:In addition to the Phare funds the investment components of the project will receive co-financing from the State budget through Directorate "National Fund" at the Ministry ofFinance to the total value of € 1 252 000 (35% of the total investment budget). 25%(€ 942 000) of the total investment budget are envisaged for joint co-financing ofequipment supply. The remaining 10% (parallel co-financing to the value of € 310 000)are foreseen for renovation and refurbishment of laboratories (Annex 10) that will ensureproper environment for the supplied equipment – see Conditionality under item 12.

11.3 Additionality:Not applicable

11.4 Project readiness and size:As a complement to the previous Phare programmes BG 9602, the current projectBG 0003.02 and Phare 2002 Project, which will be launched at the beginning of the year2003, the investments under this project are based on general evaluation of the needsrelated to the legal metrological control and quality control of liquid fuels with regard tothe successful implementation of this project and the achievement of its objectives (seeAnnex 2).The Tender Dossier for Component 4: Supply of equipment for Directorate General“National Center of Metrology” - Thermophysics measurements laboratory is preparedand approved under Phare 2000 Project “Establishing of a conformity assessmentsystem”, Sub-project BG 0003.02.03.Because of the very specific nature of the equipment to be purchased, it is necessary toreceive an expert advice on detailed elaboration of the technical specifications under allComponents prior to project implementation. Terms of reference for preparing technicalspecifications for tendering required equipment have been prepared. Detailed technicalspecification will be ready before July 2003 and will be within the project budget.

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11.5 Sustainability:The equipment to be purchased is equivalent to previous metrology laboratoryinvestments in Bulgaria and to those in other national institutes, designed for a useful lifeof at least 10 years. All equipment will be required to comply with the applicable EUnorms and standards and will be in line with EU sector policy acquis. The use of thisequipment will have positive effects on the environment through the services renderedwith it. Maintenance of the equipment, in particular the cost for periodical calibration,spare parts and supplies, will be borne by the budget of the SAMTS.

11.6 Compliance with state aids provisionsThe beneficiary of this project is a State organisation acting in the fields of metrology andfuel quality control, as a State executive function.

11.7 Contribution to NDP and/or Structural Funds Development Plan/SPDNot applicable

12 Conditionality and sequencingPrior to implementation of the project, the following conditions will have to be met:

• The secondary legislation transposing directives on medical devices (90/385/EEC,93/42/EEC and 98/79/EEC), measuring systems for liquids other than water(71/319/EEC, 71/348/EEC, 77/313/EEC, 71/318/EEC) and liquid fuels quality(1999/32/EEC and 98/70/EEC) adopted;

• The responsibilities for type examination of measuring instruments subject to legalmetrological control shifted from the DG “NCM” to the DG “MMI”;

• Before contracting of the supplies, adequate environmental conditions/stability torealise state-of-the-art measurements within the laboratories are realised. Whererespective works are necessary, those works must be contracted before publication ofthe supply tender.

Most important milestones of the Components are as follows:

Liquid Fuel Quality ControlM1 Equipment for testing of liquid fuels supplied and put into operation;M2 Staff successfully trained on specific technical and operational issues and capable to

implement the FQMS;M3 IT-system supplied and operational;M4 Staff capable to effectively use the IT-system;

Flow Rate MeasurementM1 Recommendations for improvement of the administrative and technical capacity for

the implementation of NA Directive on Measuring Instruments - Flow ratemeasuring instruments - made on the basis of the assessment.

M2 Staff trained on implementation of draft NA Directive on Measuring Instruments -Flow rate measuring instruments - and respective WELMEC documents;

M3 Staff trained on uncertainty budget of the testing procedures;

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M4 The necessary environmental laboratory conditions and respective works realised.M5 Testing equipment supplied and operational

Metrological control of medical devices with measuring functionsM1 Administrative, technological and technical capacity of laboratories for carrying out

metrological control of measuring instruments used in health care assessed;M2 Strategy for development of metrological activities regarding measuring instruments

used in health care developed;M3. Staff trained on carrying out metrological control of measuring instruments used in

health care in compliance with the European practice;M4 The necessary environmental laboratory conditions and respective works realised.M5 The necessary equipment supplied and operational.

Thermophysics measurementsM1 The necessary equipment supplied and operational.

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ANNEXES TO PROJECT FICHE

1. Logical framework matrix in standard format

2. Needs assessment

3. Requirement equipment specification for liquid fuels testing laboratories

4. Requirement equipment specification for flow rate measurement laboratory5. Requirement equipment specification for laboratories for metrological control of medical devices

with measuring functions6. Equipment specification for thermophysics measurement laboratory7. Implementation capacity report8. Detailed implementation chart9. Contracting and disbursement schedule10. Reconstruction works and refurbishment of SAMTS laboratories under national parallel co-

financing__________________________________________________________________________________

Acronyms and Abbreviations

AP Accession PartnershipCFCU Central Finance and Contracts UnitCIML International Conference on Legal MetrologyDG "QCLF" Directorate General "Quality Control of Liquid Fuels"DG "MMI" Directorate General "Measures and Measuring Instruments"DG "NCM" Directorate General "National Center of Metrology"

EC Delegation Delegation of the European Commission to BulgariaEU European UnionEUROMET European collaboration I measurement standardsFQMS Fuel Quality Monitoring SystemITS International Temperature ScaleIB Institutional BuildingI InvestmentNA New ApproachNPAA National Programme for the Adoption of the AcquisPECA Protocols to the Europe Agreement on Conformity Assessment and Acceptance

of Industrial ProductsSAMTS State Agency for Metrology and Technical SurveillanceTA Technical AssistanceWELMEC Western European Legal Metrology Co-operation

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ANNEX 1Phare log frame

LOGFRAME PLANNING MATRIX FORProject

Programme name and number

Strengthening of the administrative and measurement capacity for enforcement oflegislation on liquid fuels and measuring medical devices

Contracting period expires31.12.2005

Disbursement periodexpires: 31.12.2006

Total budget: € 4 477 000 Phare budget: € 3 225 000

Overall objectives Objectively verifiable indicators Sources of VerificationEnforcement of the aqcuis related to liquidfuels quality control and a national liquidfuels quality monitoring system in order toensure environmental protection;Enforcement of the aqcuis related tomeasuring systems for liquids other thanwater;

Positive assessment ofharmonisation and enforcement ofacquis by EC;

Air pollution level (with specificelements) decreased by 20 %;Reports of consumer protectionNGOs and state administration;

EC Regular Report;Green books on theenvironment condition in theRepublic of Bulgaria approvedby the National Assembly;MoEW;Yearbooks of the ExecutiveAgency "Environment";

Ensuring metrological control of measuringinstruments used in health care;

Positive assessment of calibrationand measurement capacity (CMC)in the temperature and connectedfields (electrical quantities, length,mass, volume, flowrate, pressure,physico-chemical measurements);

Reports on the status ofEUROMET CMC;

Establishing international recognition oftemperature and effected measurementresults creating the technical conditions torespond to the service demand in certainindustry sectors.

Successful participation ininternational comparisons.

EUROMET project report.

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Project purpose Objectively verifiable indicators Sources of Verification AssumptionsThe project purpose is to ensure effectiveand reliable liquid fuels quality control, andproper metrological control of measuringinstruments in the field of health care andliquid fuels, and temperature measurementstraceability and equivalence, while thespecific purposes are as follows:Strengthening the administrative,monitoring and testing capacity forenforcement of the acquis related to thefield of liquid fuels quality control;

Liquid fuels placed on the market incompliance with the provisions ofthe applicable ordinances;800tested samples taken in thecountry for one year period;

Reports on analytical andstatistical results for marketedliquid fuels in the country;Annual report, SAMTS;

Register of types of measuringinstruments approved for use inthe Republic of Bulgaria;

Strengthening the administrative andtechnical capacity for enforcement of theacquis related to measuring systems forliquids other than water;Strengthening the administrative andtechnical capacity for carrying outmetrological control of measuringinstruments used in health care;

Extended scope of the legalmetrological control in therespective fields;Positive control records from DG“QCLF” and DG “MMI”; Annual report on verification of

DG "MMI";

Establishing state-of-the-art standardlaboratory for thermophysicsmeasurements.

Plan for participation ininternational comparisons.

SAMTS, EUROMET projects.

Economic developmentdoes not undergosignificant changes thatcan jeopardise theprojections for projectimplementation;Investment climatecontinues to improve inthe fields of heal thcareand industry.

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Results Objectively verifiable indicators Sources of Verification AssumptionsComponent 1:Technical Assistance Quality Control ofLiquid FuelsR1.1 Staff capable to autonomouslyimplement the national liquid fuels qualitymonitoring system (FQMS);

At least satisfactory rating of thestaff trained about the results oftraining;

Training records;Training manualsProject reports at SAMTS andCFCU;

R1.2 An IT-system for management of dataand activities related to liquid fuels qualitycontrol established and customised for therespective application;

User manual;Operational reports; Project reports at SAMTS and

CFCU;

R1.3 Staff trained to be able to effectivelyuse that IT-system. Staff able autonomously to use the

IT-system;

Training records;Training manuals;Project reports at SAMTS andCFCU;

Supply of Equipment for Quality Controlof Liquid FuelsR1.4 Equipment for testing liquid fuelsquality supplied and operational (see Annex3);R1.5 IT-system hardware and softwaresupplied and operational (see Annex 3).

Testing equipment supplied andoperational by the end of May 2005at the DG "QCLF" Departments;IT system meeting the requirementsof prEN 14274:2001 supplied by theend of May 2005 at the DG "QCLF"Departments.

Acceptance reports at SAMTSand CFCU;

Technical Assistance for Flow RateMeasurement LaboratoryR2.1 Analysis with recommendations forimprovement of the administrative andtechnical capacity for the implementation ofNew Approach Directive on MeasuringInstruments - Flow rate measuringinstruments;

Analyses documentation andrecommendations;

SAMTS, CFCU;

State budget provided bythe Ministry of Financesecuring adequate fundsfor ensuring the framingoperational conditions(control, tests, etc.);Qualified staff retained bySAMTS Management;Testing laboratory withinDG “QCLF” accreditedby EA “BAS”;Relevant level of therelated fields activities ofother national standardlaboratories at DG“NCM”.

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R2.2 Staff trained on implementation ofdraft New Approach Directive onMeasuring Instruments - Flow ratemeasuring instruments - and respectiveWELMEC documents to be able to carryout the respective measurements;

Staff able to implement the relevantprocedures without externalassistance;

Training records and manuals;Project reports at SAMTS andCFCU;

R2.3 Staff trained on uncertainty budgetof the testing procedures.

At least satisfactory rating of thestaff trained about the results oftraining;Staff able to calculate theuncertainty budget without externalassistance;

Project reports at SAMTS andCFCU.

Supply of Equipment for Flow RateMeasurement LaboratoryR2.4 Fuel flow rate equipment, traceableto internationally recognised measurementstandards, supplied and operational (seeAnnex 4).

Fuel flow rate equipment suppliedand operational by the end of May2005 at the DG "MMI" laboratory.


Component 3:Technical Assistance for Laboratories formetrological control of medical deviceswith measuring functionsR3.1 Administrative, technological andtechnical capacity of laboratories forcarrying out metrological control ofmeasuring instruments used in health careassessed;

Administrative and technicalcapacity assessment report;

Project reports at SAMTS andCFCU;

R3.2 Strategy for development ofmetrological activities regarding measuringinstruments used in health care afterimplementation of New Approach MedicalDevices Directive ;

Strategy for development ofmetrological activities related tomedical devices with measuringfunctions ;

Project reports at SAMTS andCFCU;

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R3.3 Staff trained and able toautonomously carrying out metrologicalcontrol of measuring instruments used inhealth care in compliance with Europeanpractice.

At least satisfactory rating of thestaff trained about the results oftraining;

Training manuals and records;Project reports at SAMTS andCFCU;

Supply of Equipment for Laboratoriesfor metrological control of medicaldevices with measuring functionsR3.4 Equipment for type examination andinitial verification of medical devices withmeasuring functions, traceable tointernationally recognised measurementstandards, supplied and operational (seeAnnex 5).

Equipment supplied and operationalby the end of May 2005 at DG"MMI" laboratories for metrologicalcontrol of medical devices withmeasuring functions.


Component 4:Supply of Equipment for Thermophysicsmeasurements laboratoryR.4.1 Equipment for Thermophysicsmeasurement laboratory, traceable tointernationally recognised measurementstandards, supplied and operational (Annex6).

Equipment supplied and operationalby the end of May 2005 at DG"NCM" Thermophysicsmeasurement laboratory.

Acceptance reports at SAMTSand CFCU.

Activities Means AssumptionsComponent 1:Technical Assistance for Directorate General“Quality Control of Liquid Fuels” (DG “QCLF”)A1.1 Staff training on specific technical andoperational issues related to implementation of theliquid fuels quality monitoring system (FQMS);A1.2 Consulting engineering on customisingapplications and assistance to staff in putting intooperation of a computerised management system for

1 service contract for technicalassistance including:

Consultancy; Expert advice; Training; Workshops; Documentation, , procedures

preparation.

The relevant laws and normative acts relatedto fuel quality and medical devices adoptedby the Council of Ministers and Parliament;The beneficiary agency recruits and retainsstaff with adequate experience andqualification; Required environmental conditions withinthe respective laboratory premises ensured bySAMTS ;

20

liquid fuels quality control and related activities;A1.3 Staff training on use of the IT-system;A1.4 Organisation and participation in internationalproficiency testing.

Supply of Equipment for Directorate General“Quality Control of Liquid Fuels”A1.5 Procurement of equipment for testing ofliquid fuels and its putting into operation;A1.6 Procurement of IT-system hardware andsoftware and their putting into operation.

Component 2:Technical Assistance for Directorate General“Measures and measuring Instruments” (DG“MMI”) - Flow Rate Measurement LaboratoryA2.1 Assessment and preparation ofrecommendations for improvement of theadministrative and technical capacity for theimplementation of New Approach Directive onMeasuring Instruments - Flow rate measuringinstruments.A2.2 Training of staff on implementation of thedraft New Approach Directive on MeasuringInstruments - Flow rate measuring instruments - andrespective WELMEC documents;A2.3 Training of staff on uncertainty budget of thetesting procedures.

Supply of Equipment for Directorate General“Measures and Measuring Instruments” - FlowRate Measurement LaboratoryA2.4 Procurement of fuel flow rate equipment,traceable to internationally recognised measurementstandards, and its putting into operation.

1 supply tender with 4 Lots (up to fourcontracts):

tender dossier; international open tender; acceptance procedures;

training.

21

Component 3:Technical Assistance for Directorate General“Measures and Measuring Instruments” -Laboratories for metrological control of medicaldevices with measuring functionsA3.1 Workshop and introduction of the EU practicein metrological control of measuring instrumentsused in health care;A3.2 Assessment of the administrative,technological and technical capacity of laboratoriesfor carrying out metrological control of measuringinstruments used in health care;A3.3 Elaboration of strategy for development ofmetrological activities regarding measuringinstruments used in health care after theimplementation of New Approach Medical DevicesDirective;A3.4 Practical training in EU Member States oncarrying out metrological control of measuringinstruments used in health care.

Supply of Equipment for Directorate General“Measures and Measuring Instruments” -Laboratories for metrological control of medicaldevices with measuring functionsA3.5 Procurement of equipment for typeexamination and initial verification of measuringinstruments used in health care, traceable tointernationally recognised measurement standards,and its putting into operation.

Component 4:Supply of Equipment for Directorate General“National Centre of Metrology” (DG “NCM”) -Thermophysics measurements laboratory

22

A.4.1 Procurement of metrology equipment forThermophysics laboratory, traceable to internationalmeasurement standards, and its putting intooperation.PreconditionsThe secondary legislationtransposing directives onmedical devices,measuring systems forliquids other than waterand liquid fuels qualitycontrol adopted in thecourse of 2002/2003;The responsibilities fortype examination ofmeasuring instrumentssubject to legalmetrological controlshifted from the DG“NCM” to the DG“MMI”;Before contracting of thesupplies, adequateenvironmentalconditions/stability torealise state-of-the-artmeasurements within thelaboratories are realised.

23

ANNEX 2 NEEDS ASSESSMENT (Pre-feasibility study)

Quality Control of Liquid Fuels

1. Introduction

The full implementation of the acquis related to a reduction in the sulphur content of certainliquid fuels as well as to the quality of petrol and diesel fuels aims at the protection of thehuman health and environment. It requires the establishment of a national liquid fuels qualitymonitoring system.

2. Legal requirements

The Law on Ambient Clean Air adopted in 1996 lays down the general requirements for the airquality, the reduction of the polluting emissions and the rights and obligations of the state andlocal administration. On its basis Ordinance No. 17 “Limits of the content of lead, sulphur andother harmful for the environment substances in fuels” has been elaborated (published in 1999).In 1998 a National Program for gradually suspension of production and use of leaded petrol inthe Republic of Bulgaria was adopted.

In the process of implementation of Ordinance No. 17 the following was found:

- the body which carries out liquid fuels quality control, its rights and obligations arenot clarified;

- the requirements to the persons placing liquid fuels on the market are not regulated;- the deadlines for transposition of the requirements of Directive 98/70/?? and

Directive 1999/32/?C in the Bulgarian legislation are not in compliance with thedeadlines agreed in the negotiations position under Chapter 22 “Environment” at theIntergovernmental Conference for Accession of the Republic of Bulgaria to theEuropean Union.

All of the above mentioned as well as the lack of quality control of liquid fuels in Bulgaria afterthe cancellation of the border control in 1999, lead to the adoption in 2001 of the Law amendingthe Law on Ambient Clean Air in which are determined:

- the quality requirements to liquid fuels including the control on fulfilment of the qualityrequirements to liquid fuels when placing them on the market as referred to in Article 2,point 4;

- the State Agency for Metrology and Technical Surveillance (SAMTS) as the bodyresponsible for the quality control of liquid fuels in the country according to Article 30a;

- the functions of the control body as provided for in Article 30 b;- drafting of a new Ordinance on the requirements to the quality control of liquid fuels, the

conditions, procedure and methods of their control according to Article 8, paragraph 1.

This new Ordinance shall repeal Ordinance No. 17 and the following issues will be set up:

- the technical requirements, limits of content of lead, sulphur and other pollutants, to whichthe liquid fuels have to correspond on their production, import, distribution and use;

- the conditions and procedure for placing the liquid fuels on the market;

24

- the assessment of conformity of the liquid fuels with the quality requirements;- the conditions, procedure and methods of quality control of liquid fuels after their

production or import, on their distribution, including distribution to petrol stations and fuelinstallations tanks.

With the Ordinance on the requirements to the quality control of liquid fuels, the conditions,procedure and methods of their control will be transposed Directive 1999/32/EC relating to areduction in the sulphur content of certain liquid fuels and amending Directive 93/12/EEC andDirective 98/70/EC relating to the quality of petrol and diesel fuels and amending CouncilDirective 93/12/EEC. Both Directives determine the permissible content of environmentpolluters such as lead and sulphur; the permissible content of some specific fuel elements suchas polycyclic aromatic hydrocarbons, oxygen and oxygenates. The Directives determine also themethods for ?valuation of their content of fuels. In the Ordinance a mandatory quality control ofliquid fuels is envisaged regarding not only the parameters specified in the Directives but alsothose laid down in EN 228 “Automotive fuels - Unleaded petrol - Requirements and testmethods” and EN 590 “Automotive fuels - Diesel - Requirements and test methods”. Accordingto Directive 2000/71/EC dated 7 November 2000, the test methods set out in Annex I to IV ofDirective 98/70/EC should be consistent with those in EN 228 and EN 590.

The draft Ordinance was submitted for adoption to the Council of Ministers in February 2003.

The Commission Decision of 18 February 2002 sets out the common format for the submissionof summaries of national fuel quality data (Document No C(2002)508). According to Article 8,point 2 of Directive 98/70/EC and upon a request from the Commission, the EuropeanCommittee for Standardisation (CEN), Technical Committee No. 19 “Petroleum products,lubricants and related products” has developed a draft standard pr. EN 14274:2001 “Automotivefuels – Assessment of petrol and diesel quality – Fuel quality monitoring system (FQMS)”.According to item 3.2 of the draft standard, on the basis of the fuel quantity sold, countries withsales under 15 million tons are classified as small countries (including Bulgaria). Item 5.3 of thedraft standard determines the minimum number of samples that has to be taken from fuels,presenting minimum 10 % of the consumption. In case of small countries, which may bedivided into areas with relatively equal sales volume, the minimum number of sample to betaken from each type of fuel is 50 and, where the areas are with different sales volume, thisnumber is 100.

3. Infrastructure and currents status

3.1 State administration

The responsibility for the development and implementation of the governmental policy in thefield of environmental protection falls upon the Ministry of Environment and Waters.

According to the Law amending the Law on Ambient Clean Air, the State Agency forMetrology and Technical Surveillance (SAMTS) is in charge of carrying out the control on theliquid fuels quality through its Directorate General “Quality Control of Liquid Fuels” (DG“QCLF”) established for this purpose.

The Directorate General “Quality Control of Liquid Fuels” is organised in four units: "Testingof Fuels and Lubricants" Department and three “Quality Control of Liquid Fuels” Regional

25

Departments situated throughout the country. The number of their staff is 12 and 18 personrespectively. It is considered that the current staff of the Directorate is insufficient for carryingout the foreseen controlling and testing activities.

The "Testing of Fuels and Lubricants" Department includes a stationary testing laboratory witha staff of 10 persons who test lubricants on the request of natural and legal persons. The testsare carried out according to the existing Bulgarian National Standards (BDS). During 2002about 508 samples of fuels, lubricants and antifreezes were tested. The tests were carried outaccording to the total of 2320 parameters. The laboratory is accredited by the Executive Agency“Bulgarian Accreditation Service” according to BDS EN 45001 and is in process of re-accreditation according to BDS EN ISO/IEC 17025.

The departments for quality control include three regional units, which are envisaged to beestablished in Sofia, Pleven and Bourgas, after the enforcement of the Ordinance on therequirements to the quality control of liquid fuels, the conditions, procedure and methods oftheir control.

According to the Rules of the organisational structure of SAMTS the main tasks andresponsibilities of Directorate General “Quality Control of Liquid Fuels” are the following:

1. to monitor and control liquid fuels for which quality requirements are laid down inthe draft Ordinance transposing Directive 1999/32/EC and Directive 98/70/EC;

2. to undertake actions for establishment of compliance of liquid fuels with the qualityrequirements such as:

?) to examine the documents accompanying liquid fuels (a declaration of conformity and adocument certifying the ownership of the fuel);

b) to take samples of liquid fuels;c) to test the samples taken or, where necessary, to sub-contract it to accredited laboratories;d) to carry out an examination of the test results for compliance of the fuels with the quality

requirements.3. to take actions for restriction on placing on the market, distribution or use or for

withdrawal of liquid fuels from the market, in cases where a non-compliance withthe quality requirements is detected;

4. to take actions against persons who have issued a declaration of conformity of theliquid fuels, which do not comply with the quality requirements;

5. to take actions for notifying the persons likely to be exposed to risk or to be affectedby any damages of property in detecting non-compliances with the qualityrequirements;

6. to gather, process and provide information for the quality of liquid fuels to therelevant responsible institutions in the country.

In order to fulfill the requirements of Article 8, point 4 of Directive 98/70/??, the CommissionDecision dated 18 February 2002 and item 5.3 of pr EN 14274:2001 it is necessary maximum100 samples of a type of fuel or not more than 500-600 number of samples per year /3 types ofpetrol and 2 types of diesel fuel/ to be tested. Aiming at a better consumer protection, SAMTSforesees 700 planned checks and spot checks in case of signals to be carried out annually,including taking samples of liquid fuels from petrol stations, fuel depots and mobile tanks. Thesamples taken will be submitted for testing to the accredited laboratory of the Directorate inorder to be assessed for conformity with the requirements of the Ordinance. In case of non-

26

conformity of the testing results with the values of parameters specified in the documentsaccompanying the fuel, the inspectors order the withdrawal of the fuel from the market orprohibit its use in accordance with Article 30 b of the Law on Ambient Clean Air. The dataintended for the consumer protection is presented to the mass media.

3.2. Manufacturers

The main manufacturer of liquid fuels in our country is “LUKOIL-NEPHTOHIM” – Burgas,which is able to meet 100 % of the petrol and diesel fuel needs. In the course of 2001, the totalamount of liquid fuels placed on the market was over 3 213 000 t, including: 594 000 t leadedpetrol, 503 000 t unleaded petrol and 2 1124 000 diesel fuel. In 2001 the import of liquid fuelswas only 3 % of the total amount and comprised predominantly high-octane petrol and jet fuel.The increasing consumption of liquid fuels for 2005 is estimated as follows: about 3 % forpetrol (1 538 000 unleaded petrol) and about 4 % for diesel fuels (2 644 000 t). The productionof leaded petrol shall be terminated completely from 1 January 2004 further on.

3.3. Importers

The main importers were “Shell – Bulgaria” and “Naphteks”. At present “Shell” fuel-stationswork mostly (over 90 %) with “LUKOIL-NEPHTOHIM” – Burgas products.

3.4. Retailers

At present, the total number of the petrol stations in the country is more than 2000 andcontinuously new fuel stations are built. The most important distributors are “PETROL” with444 petrol stations, “Shell – Bulgaria” with 73 petrol stations, “Ecopetroleum” with 19 petrolstations and “LUKOIL – Bulgaria” with 30 petrol stations. The rest of the petrol stations areowned by small distributors and sole proprietors where the majority of the frauds is expected.

3.4.1. Market condition of the main types of liquid fuels

The consumption of the main types of liquid fuels in the country in 2001 was as follows:• leaded petrol – 592 000 t with lead content maximum 0,15 g/l and sulphur – 0,02 %;• unleaded petrol – 503 000 t with lead content – 0,013 g/l and sulphur – 0,02 %;• diesel fuels – 2 124 000 t with sulphur content – 0,2 %.

When the manufacture and consumption of leaded petrol shall be ceased after 1 January2004 the total consumption of liquid fuels in the country is estimated to be as follows:

• unleaded petrol – 1 538 000 t with lead content– 5 mg/l and sulphur – 150 mg/kg;• diesel fuels – 2 644 000 t with sulphur content– 350 mg/kg.

Parameter deviations of 24 % of the monitored fuels are determined by means of tests inSAMTS laboratory during 2002. Acting in accordance with Article 24, paragraph 1 of theOrdinance each fuel with value deviation even of only one of the tested parameters maybe considered as a fuel of poor quality.

27

3.4.2. Liquid fuel influence on the environment in the country

In accordance with the data from the Ministry of Environment and Waters, the pollutants of themotor vehicles emissions are 43,8 % of all noxious gas emissions in the atmosphere.

In 2001 the total content of both main pollutants in these products are: lead – 104,2 t, sulphur –4466 t. In 2004, the production and consumption of leaded petrol shall be terminated and as aresult in 2005 the total content of both main pollutants in these products will be as follows: lead– 10,3 t and sulphur – 1155 t. That is a reduction of about 75 % for the sulphur and about 90 %for the lead in comparison with their content in products, manufactured and used in 2001.

As a result, it can be estimated that after termination of the consumption of leaded petrol from 1January 2004 on and as a result of the reduction of sulphur content in the diesel fuels andunleaded petrol, in 2005 the atmosphere air clearness will be improved with more than 20 %.

3.5. Laboratories

There are several laboratories in Bulgaria for testing of liquid fuels. Only three of them areaccredited by Executive Agency “Bulgarian Accreditation Service” – SAMTS’s laboratory,LUKOIL – NEPHTOHIM” – Bourgas laboratory and Chemistry and Technological University(Bourgas) laboratory.

SAMTS’s laboratory is the only one state owned accredited laboratory. It was established in1974 and has a significant experience in fuel and lubricant material tests. Since 1993 theSAMTS’ lab had a new building erected according to the requirements of Article 6, point 2 ofOrdinance No 7/1992 of the Ministry of Health concerning the health protection zones in theliving areas. The laboratory has the capacity to test liquid fuels for the purposes of qualitycontrol by means of all methods, required by Bulgarian standards and regulations to the terms,determined as transitional in the negotiation Chapter 22 “Environment”.

4. Unsatisfied Needs

4.1. Equipment

The quality requirements for liquid fuels are regulated by the draft Ordinance. Till 31 December2003 SAMTS laboratory for testing of fuels and lubricants is obliged to apply the methodsrequired by the valid Bulgarian National Standards (BDS), for which the correspondingequipment is available. From 1 January 2004, EN 228 and EN 590 requirements will beimplemented, part of which are the parameters given in Directive 2000/71/EC and Directive98/70/EC. The latter refer to the assessments of the fuels from ecological point of view, and willrepresent the basis for preparation of the annual report on the quality of fuels in the country tobe submitted to the European Commission after the accession of Bulgaria to the EuropeanUnion. The implementation of EN 228 and EN 590 into the Bulgarian legislation will requireassessment of the liquid fuels quality according to new parameters not yet included in BDSpresently valid. New values of parameters such as content of lead and content of sulphur arealso included. The comparative analysis of the parameters and the analytical methods requiredby the valid BDS and the EN 228 for petrol, and EN 590 for diesel fuels to be adopted asBulgarian standards is shown in the enclosed Tables I and II. The analysis shows that:

28

1. EN 228 requires the application of atomic absorption spectroscopic method fordetermination of the lead content according to EN 237 instead of the required by BDS 16603 X-ray-fluorescent method;2. EN 228 and EN 590 lay down the dispersion X-ray-fluorescent spectroscopic methodaccording to EN ISO 14596 as obligatory arbitration method in determination of the sulphurcontent. Neither of the two European standards allows the available laboratory equipment forevaluation of sulphur according to BDS EN ISO 8754 to be used for arbitration purposes;3. EN 590 requires obligatory determination of Cetan number in the diesel fuels accordingto EN ISO 5165 together with the Cetan index according to BDS EN ISO 4264. The latter iscalculated theoretically, and the Cetan number is determined with the help of a stand;4. EN 590 requires the application of a liquid chromatographic method according to EN12916 for determination of the new parameter “content of policyclic aromatic hydrocarbons” inthe diesel fuels;5. EN 590 requires the determination of the new parameter for assessment of the lubricityof the diesel fuels according to EN ISO 12156.6. Domestic heating diesel requires the determination of the heat of combustion accordingto ISO 1928 using a bomb calorimeter. The laboratory needs a new semi-automatic one insteadof the available old manual equipment.

The laboratory personnel possesses the required experience for assessment of the liquid fuelsquality in accordance with the Commission Decision of 18 February 2002. The laboratoryshould be supplied with the necessary equipment mentioned in Annex 3 of the Project Fiche.The available equipment together with the atomic absorption spectrometer, dispersion X-rayfluorescent spectrometer, the liquid chromatograph, as well as the stand for Cetan numberdetermination will create the opportunity for carrying out total analysis of the parametersneeded for preparation of the annual report to be submitted to the European Commission.

In order to fulfil the standard and procedures requirements for accreditation, the necessary workenvironment conditions shall be ensured. It shall be necessary to establish an air-conditioningsystem.

DG “QCLF” needs two mobile laboratories for performing express analysis on site when takingsamples of petrol and diesel fuel. The aim is in due time to withdraw from the market orconsumption prohibition of fuels with ascertained non-compliance. Such mobile laboratories areused in France, Hungary, Slovenia, India and other countries. As additional arguments forestablishing these two laboratories can be indicated the following:

1. Expenditure reduction for double weekly transport of samples from the regionaldepartments to Sofia and backward. Estimation made for an yearly period shows that eachregional department will spend 7000 – 8000 Euro only for transportation of the samples toSofia.

2. The time limit reduction for determination of the fuel non-compliance with the qualityrequirements of the Ordinance. The inspectors will be able to issue prescriptions - with thehelp of which to stop the distribution and consumption of the tested product. That will resultin better consumer protection because of the quickly restrain of the fuels of poor quality.

29

4.2 Training of personnel

For rapid and precise determination of the necessary parameters using the newly suppliedequipment, a training of the staff on operation and use of the equipment provided by thesupplier must be envisaged. The training in question should include statistical processing of theresults obtained as well as the ways for their input in the liquid fuels quality monitoring system(FQMS) in order to prepare the annual report for submission to the European Commission.

4.3. Personnel

The supply of the required equipment together with the provided staff training on its use andoperation, will enable the carrying out of liquid fuels quality control in compliance with therequirements of the respective European Directives as well as the establishment of a nationalmonitoring system. This requires the availability of additional personnel of at least 27 persons.This figure is defined by the increasing number of samples for testing as well as by theincreasing number of parameters for determination required according to EN 228 and EN 590.It is foreseen the additional personnel to be distributed in the following way:

1) Two teams of two persons for each of the two mobile laboratories – 8 persons;2) 3-4 persons for the stationary laboratory who will specify the additional parameters requiredby EN 228 and EN 590?;3) 15 persons for strengthening the three regional departments for control. Each departmentcomprises of regions with an area of about 33 000 square kilometers.

30

TABLE ? AVAILABLE AND NECESSARY EQUIPMENT FOR TESTING OF AUTOMOTIVE DIESEL FUELS AT THE TESTINGLABORATORY OF DG “QCLF”

Available testing equipment according to theexisting standards by 01.01.2004

Necessary testing equipment after the implementation of?N 590 - 01.01.2004

Parameter Unit Test method andequipment

Parameter Unit Test method andavailable

equipment

Test method andnecessaryadditiona lequipment

1.Distillation:-50% recoveredat temperature-90% recoveredat temperature-95% recoveredat temperature

°?

°?

°?

BDS ISO 3405:19981. Automatic apparatus fordetermination of thedistillation V-1570 ofAltrem-France;2. Automatic apparatus fordetermination of thedistillation HAD 628-Herzog-Germany;3.Manual apparatus fordetermination of thedistillation according toEngler-LPH-Russia

1.Distillation:-% recovered at250°?

-% recovered at350°?

-95% recovered at360°?

%(V/V)

%(V/V)

°?

BDS ISO 3405:19981. Automaticapparatus fordetermination of thedistillation V-1570of Altrem-France; 2. Automaticapparatus fordetermination of thedistillation HAD628-Herzog-Germany;3. Manual apparatusfor determination ofthe distillationaccording to Engler-LPH-Russia

No additionalequipment is

necessary

2. Sulphur % BDS EN ISO 8754 :20021. X-Ray fluorescenceanalyiser LAB X 3000 ofOxford instruments-UKBDS 7105-832. Equipment for sulphurdetermination by lampmethod with range of over0,01%

2. Sulphur mg/kg 1.BDS EN ISO 8754:2002X-Ray fluorescenceanalyiser LAB X3000 of Oxfordinstruments-UK2.EN ISO 24260:1994Wickboldcombustion method

EN ISO 14596:1998Wavelengthdispersive X-rayfluorescencespectroscopicmethod

31

3. Kinematicviscosity at 20°?

mm2 /s

BDS EN ISO 3104+AC01 Equipment fordetermination of thekinematic viscosity at20°? with thermostat DL-3 of Haake-Germany

3. Kinematicviscosity at 20°?

mm2 /s BDS EN ISO3104+AC 01Equipment fordetermination of thekinematic viscosityat 20°? withthermostat DL-3 ofHaake-Germany


necessary

4. Flash point °? BDS ISO 2719: 1993Equipment fordetermination of flashpoint by Pensky-Martensof Herzog-Germany

4. Flash point °? EN 22719: 1993Equipment fordetermination offlash point byPensky-Martens ofHerzog-Germany


necessary


Available and necessary testing equipment after the implementation of?N 590 - 01.01.2004


Parameter Unit Test method andavailable equipment

Test method andnecessary additional

equipment- - - 5. Cetane number - ?N ISO 5165:1998

Cetane method fordetermination ofcombustibilitycharacteristics

5. Cetane index - BDS EN ISO4264:2001Calculation methodon the basis ofdistillationcharacteristics byequations with fourvariable quantitiesdetermined throughfraction analysis of

6. Cetane index - BDS EN ISO4264:2001Calculation methodon the basis ofdistillationcharacteristics byequations with fourvariable quantitiesdetermined troughfraction analysis of


necessary

32

the composition anddensity

the composition anddensity

6. Cold filterplugging point

°? BDS ?N 116: 2002Equipment fordetermination of coldfilter plugging point-HCP 842 of Herzog-Germany

7. Cold filterplugging point

°? BDS ?N 116: 2002Equipment fordetermination of coldfilter plugging point-HCP 842 of Herzog-Germany


necessary

7.Cloud point °? BDS ?N 23015Equipment fordetermination ofcloud pour point HCP852 of Herzog-Germany

8. Cloud point °? BDS ?N 23015Equipment fordetermination ofcloud pour pointHCP 852 of Herzog-Germany


necessary

8.Aromatichydrocarbons

% BDS ?N 23015SpectrophotometerSpecord 75 IR-Germany

- - - No additionalequipment is

necessary

9. Water content mg/kg

EN ISO 12937:1996Coulometric KarlFisher titration

method fordetermination of

water content


necessary

10. Totalcontamination

mg/kg

EN 12662 No additionalequipment is

necessaryAvailable testing equipment according to the

existing standards by 01.01.2004Available and necessary testing equipment after the implementation of

?N 590 - 01.01.2004Parameter Unit Test method and

equipmentParameter Unit Test method and

available equipmentTest method and

necessary additionalequipment

9. Mechanicaladditives and water

- BDS 8884-89visually


necessary

33

10. Acidity mgKOH/100sm3

product/

BDS 1752-88Titration withpotassium hydroxide(? ? ? )


necessary

11. Carbon residueon 10% distillationresidue

% 1.BDS ISO 6615:2001Equipment for carbonresidue determinationby Konradson -Germany2.EN ISO 10370Equipment for carbonresidue determination– micro method typeMCRT-140- USA

11. Carbon residueon 10% distillationresidue

% EN ISO 10370Equipment forcarbon residuedetermination –micro method typeMCRT-140- USA


necessary

12. Ash content % BDS EN ISO6245:1999

Muffle furnace

12. Ash content % BDS EN ISO6245:1999 Mufflefurnace


necessary13. Sulpharettedhydrogen testing

- BDS 5579-70 - - - No additionalequipment is

necessary14.Copper stripcorrosion

- BDS 5747-84Equipment fordetermination of copperstrip corrosion

13. Copper stripcorrosion

- EN ISO 2160 Equipment fordetermination ofcopper stripcorrosion


necessary

15.Iodine number gJ/100

gproduc

t

Values of CIF 2384-80


necessary

34

16.Oxidationstability

g/m 3 BDS 17197-94Equipment forfiltration in oxygenenvironment andweight determination

14. Oxidationstability

g/m 3 EN ISO 12205Equipment forfiltration in oxygenenvironment andweight determination


necessary

- - - 15.Polycyclicaromatichydrocarbons

%(m/m

)

- IP 391: 1995High performanceliquidchromatography withrefractive indexdetection




Parameter Unit Test method andavailable equipment


equipment17. Density (at20°? )

kg/m3 EN ISO 3675:1998Hydrometer method

16. Density (at 15°?)

kg/m3

EN ISO 3675:1998Hydrometer method


necessary- - - 17. Lubricity,

corrected wear scardiameter at 60°C

µm ISO 12156-1Equipment for

assessment of thelubricity

- - - 18. Viscosity at40°C

mm2 /s

EN ISO 3104Equipment fordetermination ofkinematic viscositywith thermostat DL-3of Haake-Germany


necessary

- - - 18.Heat ofcombustion of dieseldomestic heatingoils

ISO 1928Semi-automaticbomb calorimeter forevaluation of the heatof combustion

35

TABLE ?? -AVAILABLE AND NECESSARY EQUIPMENT FOR TESTING OF FUELS FOR PETROL ENGINES AT THE TESTINGLABORATORY OF DG “QCLF”





equipment


equipment1. Research octanenumber – RON

- 1. Research octanenumber – RON

EN 25164:1993Stand CFR forresearch octanenumberdeterminationaccording toWaukesha-USAmethod

No additionalequipment is necessary

2. Motor octanenumber - MON

Value of CIF 2183-8Stand for octanenumberdetermination, type???-Russia

2. Motor octanenumber

EN 25163:19931. Stand for motoroctane numberdeterminationaccording toWaukesha- USAmethod

No additionalequipment is necessary





equipment


equipment2.Density at 15°? g/sm

3BDS ?N ISO3675:1998Glass hydrometerfor relative density

2. Density at 15°? g/sm 3 1.BDS ?N ISO3675:1998Glass hydrometerfor relative density


necessary

3. Distillationcharacteristics:-up to 70°?distillate volumepart

%

%

BDS ISO 3405:19981. Automaticapparatus fordetermination ofdistillation V-1570

3. Distillationcharacteristics:-up to 70°? distillatevolume part-up to 100 °? distillate

%

%

BDS ISO3405:19981. Automaticapparatus fordetermination of


necessary

36

-up to 100 °?distillate volumepart-up to 180 °?distillate volumepart-boiling point-residue of volumepart distillation

%

°?%

of Altrem-France;2. Automaticapparatus fordetermination ofdistillation HAD628-Herzog-Germany;3.Manual apparatusfor determination ofdistillation accordingto Engler-LPH-Russia

volume part-up to 180 °? distillatevolume part-boiling point-residue of volumepart distillation

%

°?

%

the distillation V-1570 of Altrem-France; 2.Automaticapparatus fordetermination ofthe distillationHAD 628-Herzog-Germany;3.Manual apparatusfor determination ofthe distillationaccording toEngler-LPH-Russia

4. Saturated vaporpressure

??? BDS EN 12:2001Equipment fordetermination ofReid vapor pressure

4. Saturated vaporpressure

??? 1.BDS EN 12:2001Equipment fordetermination ofReid vapor pressure


necessary

5. Lead g/sm3

BDS 8436-87Titration methodBDS ?N16603:1987X-ray fluorescenceanalyiser Lab X3000 of Oxfordinstruments-UK

5. Lead g/sm 3 - EN 237:1996Equipment fordetermination of lowlead concentrations byatomic absorptionspectrometry

6. Sulphur % BDS EN ISO 8754:20021. X-rayfluorescenceanalyiser LAB X3000 of Oxfordinstruments-UKBDS 7105-832. Equipment forsulphur

6. Sulphur % 1. BDS EN ISO8754 :2002X-ray fluorescenceanalyiser LAB X3000 of Oxfordinstruments-UK2.EN 24260: 1994Wickboldcombustion method

3.EN ISO 14596:1998Equipment for sulphurdetermination bywavelength dispersivex-ray fluorescencemethod

37

determinationaccording to lampmethod with therange of above0,01%





equipment


equipment8. Gum content(solvent washed)

mg/100sm3

BDS ISO 6246: 93Equipment fordetermination of thegum content -Stanhope-Seta SP-12E, England

8. Gum content(solvent washed)

mg/100sm3

BDS ISO 6246: 93Equipment fordetermination ofthe gum content -Stanhope-Seta SP-12E, England


necessary


BDS ISO 2160:1995Equipment fordetermination ofcopper stripcorrosion


BDS ISO 2160:1995 Equipment fordetermination ofcopper stripcorrosion


necessary

10. Induction period min BDS EN ISO 7536:2001Equipment fordetermination ofinduction period -NormaLabNPI 420 - France

10. Induction period min BDS EN ISO 7536:2001Equipment fordetermination ofinduction period -NormaLab NPI 420– France


necessary

- - - 11. Hydrocarbon typecontent:olefinsaromatics

%(V/V)

ASTM-D 1319:1995 Fluorescentindicator adsorptionmethod


necessary

- - - 12. Oxygen andoxygenatescompounds

%(V/V)

1.?N 1601:1997Equipment fordetermination by


necessary

38

gaschromatographymethod2.?N 13132;1998Equipment fordetermination bygaschromatographymethod

39

Measuring Systems for liquids other than water

1. Introduction

The full implementation of the acquis related to measuring systems for liquids other than waterrequires establishing of a national system for control of such measuring instruments.

Construction and methods for control of measuring systems for liquids are subject to mandatoryprovisions, which differ in different countries and subsequently create barriers to trade in thesesystems. That requires harmonization of Bulgarian national legislation with Europeanlegislation in this field, which is going to ensure:

• consumers protection from false measurement results in direct sale of liquid fuels;• reliability and accuracy of the measurement results, related to business transactions, which

are subject to taxation, customs and excise duties.


The normative document that regulates activities related to measuring systems for liquids otherthan water, is the Law on Measurements. In accordance with that Law and in order to ensureaccuracy and reliability of the measurement results all measuring instruments that are used inthe health sector, public safety, environmental protection, state and municipal receivables andtrade payments are subject to metrological control. A draft Ordinance on the requirements to themeasuring instruments is elaborated under the Law and it is forthcoming to be adopted by theCouncil of Ministers. The draft Ordinance fully transposes European Directives related tomeasuring systems for liquids other than water as follows: Directive 77/313/EEC on Measuringsystems for liquids other than water; Directive 82/625/EEC on Measuring systems for liquidsother than water; Directive 71/319/EEC on Meters for liquids other than water and Directive71/348/EEC on Ancillary equipment for meters for liquids other than water. According to thedraft Ordinance these systems are subject to type approval testing, initial and subsequentverification.

3. Infrastructure

3.1 State administration

According to the Law on Measurements the President of the State Agency for Metrology andTechnical Surveillance (SAMTS) shall implement the governmental policy in the field ofmeasurements. Within the agency the activities related to metrological control of measuringinstruments are carried out by Directorate General "Measures and Measuring Instruments" (DG"MMI"). According to the SAMTS' Rules of the Organisational Structure, DG "MMI" has thefollowing obligations in that field:

1. carries out examination for type approval of measuring instruments subject to controlaccording to the Law on Measurements and the normative acts for its implementation by testingof the measuring instruments and their software;2. proposes to the SAMTS President type approval of the measuring instruments;3. keeps a register of the types of measuring instruments approved for use;4. carries out initial and subsequent verification of measuring instruments subject to controlaccording to the Law on Measurements and the normative acts for its implementation;

40

5. carries out a metrological expertise of measuring instruments subject to control accordingto the Law on Measurements and the normative acts for its implementation.

In order to carry out the above mentioned obligations DG "MMI" is organised as follows:

• 1 testing department for type approval of measuring instruments, located on the territory ofSofia with a staff of 45 persons. Three laboratories in the Department are in a process ofaccreditation for testing according to ISO/IEC 17025, PHARE 2000 Programme, Project BG0003.02.02. Eight persons are directly engaged in carrying out testing of measuring systemsfor liquids other than water.

• 16 regional departments all over the country which perform initial and subsequentverification of measuring instruments. The number of staff is 285. Ninety persons aredirectly engaged in carrying out initial and subsequent verification of measuring systems forliquids other than water.

3.2 Producers

There are no manufacturers of measuring systems for liquids other than water in the country.There are only manufacturers that produce ancillary equipment to those systems like indicationdevices and counters. Those firms are: "Petrol engineering" PLC, Sofia; "Deizi Technology"Ltd., Sofia; "Electronica" PLC, Sofia; "Stefan Stanchev - Ruse" sole proprietor, Ruse; "C. A. E.- Stefan Chakarov" sole proprietor; "Kalvacha" PLC; "Izotserviz Stara Zagora" Ltd.; "Efir -Hristo Dinev" sole proprietor; "Arieskomers"; etc.

There are also firms in Bulgaria that recycle and assemble measuring systems for liquids otherthan water like "Kalvacha" PLC and "Efir - Hristo Dinev" sole proprietor, Stara Zagora;"Izotserviz Stara Zagora" Ltd.; "Stefan Stanchev - Ruse" sole proprietor; "Stoikovi & Co."partnership; "D & D - Snejana Damyanova" sole proprietor; "Paldin gas" Ltd.; "Plam 99Plamen Donchev" sole proprietor; "Petrol engineering" PLC, Sofia.

3.3 Importers

The main importers of measuring systems for liquids other than water are mostly from the EUMember States, such as "DEIZI TECHNOLOGY" Ltd.; "Kalvacha" PLC; "Bulvaria holding"PLC; "Stoikovi & Co." partnership; "Petrol engineering" PLC; "Petrosystems" Ltd.; Petposan -BC" Ltd.; "Plam 99 Plamen Donchev" sole proprietor; "Jelev" Ltd.; "ROE Bulgaria" Ltd.;"Avanty Bulgaria" Ltd.; "MARINO" Ltd.; "Bulmarket DM" Ltd.; "Evrogaz - 99" Ltd.; "StefanStanchev - Ruse" sole proprietor; "Gruev - Nikola Gruev" sole proprietor; "WOLF" Ltd.;"Petrol" PLC"; "Shell Bulgaria" PLC; "Scheidt & Bahman - Bulgaria" Ltd.; "Ariescomers";"Etalon Stoikov" Ltd. Part of those importers are authorized representatives of leadingEuropean firms. Most of the measuring systems for liquids other than water offered toBulgarian market are second hand. That requires strengthened control of those systems.

4. Capacity for legal metrological control

Type approval testing and metrological control of measuring systems for liquids other thanwater is limited to determination of the flow rate and the accuracy of the systems. Technicalcapacity for testing of ancillary equipment and determination of its influence on themeasurement accuracy is missing. It is not possible to take into account the influence of the

41

external factors (ambient temperature and liquid temperature, liquid viscosity) on the accuracy,required by the Directive 71/319/EEC and Directive 71/313/EEC.

For the period October 1991 - October 2002, 44 types of gas dispensers (LPG dispensers), 85types of fuel dispensers and 24 types of flow meters are approved and used in the country.

5. Unsatisfied Needs

5.1. Equipment

In accordance with Directive 71/313/EEC the type approval testing of measuring systems forliquids other than water requires testing of the standard and ancillary equipment of the system isas follows:

1. Flow rate meter - Determination of the accuracy curve line as a flow rate function inthe range between the minimum and maximum flow rate. Testing must be carried out atmaximum and minimum temperature and at the set viscosity values as well as for the minimumquantity supply.

2. Air or gases removal system;3. Non-variation of full hoses volume;4. Influence of the liquid pressure and temperature on the flow rate meter and system

accuracy;5. Influence of the liquid viscosity on the accuracy.

The available equipment, metal capacity measures 5, 10, 20, 50, 100 and 200 [1] with accuracy0.02 %, metal capacity measures 5, 10, 20, 50, 100 and 200 [1] with accuracy 0.1 % andstandard flow rate meters for liquefied hydrocarbon with accuracy 0.25 %, allows onlydetermination of the accuracy curve line as a flow rate function. In order to carry out therequired testing according to the Directive it is necessary the standard equipment, specified inAnnex 4, to be supplied.

According to Directive 71/313/EEC the initial verification of the measuring systems is carriedout in one or two stages. The Directive lays down that the verification should be carried out inone stage (stationary laboratory), in cases when the system is produced by one manufacturer,can be transported without disassembling and the verification is carried out under normalconditions, for which the system is intended to work. In all other cases the verification shouldbe carried out in two stages. In the first stage flow rate meters and the relevant ancillaryequipment are tested. The testing can be carried out by testing stand or by installed measuringsystem with liquids different from those intended for use in the system. The second stage iscarried out at the assembling place, under working conditions, and by the liquid intended foruse in the system. The latter requires mobile testing laboratory for such systems. In over 90% ofthe cases in Bulgaria it is necessary testing of measuring systems for liquids other than water tobe carried out in two stages.

2. Training of personnel

The full implementation of the directives provisions and requirements of the recommendationsrequires training of staff on their implementation and operation of the equipment, after itssupply. The need of staff training on preparation of uncertainty budget applied in testing is

42

related to the implementation of EA-3/02 "The Expression of Uncertainty in QuantitativeTesting", 1996 in the laboratories accreditation according to ISO/IEC 17025.

The specific Directive 71/313/EEC and Directive 71/319/EEC both relate to certain types ofmeasuring instruments that contain detailed technical specifications. They are limiting takingaccount of the rapidly changing measuring technologies. The requirements laid down in thedraft New Approach Directive on Measuring Instruments will be addressed to theworking/operational characteristics of measuring instruments, rather than to the ones relating todesign. This envisages a new concept in the field of metrology in which the role of testing,conformity assessment and the initial verification grow/increase substantially. For this purposeit is necessary a staff to be trained on the implementation of the New Approach Directive.

43

Measurements in the health sector

1. Introduction

Bulgaria is in a process of harmonisation of its national legislation with the European one. Inrelation with the principles of acquis it shall transpose the three directives on medical devices:Directive 93/42/EEC on Medical devices, Directive 98/79/EC on In vitro diagnostic medicaldevices and Directive 90/385/EEC on Active implantable medical devices.

Traditionally a part of the medical devices with measuring functions are subject to legal controlin Bulgaria.


The Law on Technical Requirements to Products is a horizontal framework for transposition ofthe New Approach Directives into the national legislation. This Law transposes into the nationallegislation the principles of the New Approach relating to technical regulation as well as theGlobal Approach principles relating to conformity assessment. It provides for a presumption ofconformity with the corresponding essential requirements in case of compliance of productswith Bulgarian standards transposing the harmonised European standards under the NewApproach Directives. A conformity marking is introduced as a proof that the product complieswith the essential requirements and has been subject to the relevant conformity assessmentprocedure.

The New Approach Directives are being transposed into the Bulgarian legislation as ordinancesunder the Law on Technical Requirements to Products. According to this Law, the President ofthe State Agency for Metrology and Technical Surveillance shall issue and withdrawauthorisations for carrying out conformity assessment with the essential requirements toproducts.

The elaboration of draft ordinances for implementation of the European directives on medicaldevices has been assigned to the Ministry of Health and the Ministry of Economy by a decisionof the Council of Ministers. According to the Law on Technical Requirements to Products themarket surveillance of medical devices shall be carried out under the provisions of a separatelaw. At present a Draft Law on Medical Devices is being elaborated which provides the marketsurveillance to be carried out by the Ministry of Health through the Executive Agency onDrugs. A full transposition of the European legislation in this field into the national legislationwill be achieved by the above mentioned ordinances. The transposition and enforcement of thislegislation requires strengthened coordination and cooperation between the respective stateinstitutions.

According to the Law on Measures and Measuring Instruments adopted in 1948 all types ofmeasuring instruments are subject to metrological control in Bulgaria. The Law has beenamended many times but without any change as regards the scope of its effect.

In 1998 a Law on Measurements was adopted which repeals the Law on Measures andMeasuring Instruments. This Law defines, for the first time, fields in which the measuringinstruments used are subject to legal metrological control. According to the Law onlymeasuring instruments that have a positive result from the metrological control are allowed foruse in the healthcare sector for prophylactics, diagnostics, treatment, rehabilitation as well as formanufacture, analysis and control of drugs.

44

During the period 1998-2001, the process of harmonisation of the national legislation with theEuropean one in the field of legal metrology lead to the adoption of a new Law onMeasurements in 2002. The latter repeals the law from 1998. One of the main objectives of thisnew law is to protect the health and life of people as well as the environment from the harmfulimpacts which can occur due to false measurements results. According to the law, the Presidentof the State Agency for Metrology and Technical Surveillance (SAMTS) shall approve the typeof the measuring instruments subject to legal control. The European directives in the field oflegal metrology and pre-packaged products are fully transposed by this law and the ordinancesfor its implementation, a part of which are to be adopted by the Council of Ministers. The draftOrdinance on the requirements to measuring instruments defines the measuring instruments thatare subject to legal control, including these that are subject to legal control because of nationalspecifics and reasons. In the field of healthcare the following medical devices with measuringfunctions are subject to control: clinical thermometers, blood pressure meters,electrocardiographs, audiometers, clinical dosimeters, focimeters.

The requirements to measuring instruments for which no relevant European directives exist arelaid down on the basis of the respective recommendations of the International Organisation forLegal Metrology (OIML).

According to Article 26, paragraph 3 of the Law on Measurements, where the measuringinstruments bear the conformity marking in accordance with the Law on TechnicalRequirements to Products, they are subject to subsequent verification.

According to the Law on Measurements, only medical devices with measuring functions thathave a positive result from the metrological control must be used in the health sector.

3. Infrastructure

3.1. State administration

According to the Law on Measurements the President of the State Agency for Metrology andTechnical Surveillance (SAMTS) shall carry out the state management in the field ofmeasurements. Within the agency the activities related to metrological control of measuringinstruments are carried out by Directorate General "Measures and Measuring Instruments" (DG"MMI"). According to the SAMTS' Rules of the Organisational Structure, DG "MMI" has thefollowing obligations in that field:1. carries out examination for type approval of measuring instruments subject to control

according to the Law on Measurements and the normative acts for its implementation bytesting of the measuring instruments and their software;

2. proposes to the SAMTS President type approval of the measuring instruments;3. keeps a register of the types of measuring instruments approved for use;4. carries out initial and subsequent verification of measuring instruments subject to control

according to the Law on Measurements and the normative acts for its implementation;5. carries out a metrological examination of measuring instruments subject to control

according to the Law on Measurements and the normative acts for its implementation;6. in accordance with the technical capacity of the laboratories in the regional departments,

carries out calibration of measuring instruments subject to control according to the Law onMeasurements and the normative acts for its implementation;

45

7. participates in the work of the International Organisation for Legal Metrology (OIML), theEuro-Asian Cooperation of National Metrological Institutions (COOMET), the WestEuropean Legal Metrology Cooperation (WELMEC) and in relation with the EuropeanAgreement Concerning the Work of Crews of Vehicles Engaged in International RoadTransport (AETR), in the work of the United Nations Organisation (UNO) EconomicCommission for Europe.

With a view to fulfilling the above specified obligations, DG "MMI" is organised in thefollowing way:• 1 testing department for type approval of measuring instruments, located on the territory of

Sofia with a staff of 45 persons.• 16 regional departments, located throughout the country, which carry out initial and

subsequent verification of measuring instruments. The number of staff is 285 persons.

3.2. Manufacturers

In Bulgaria mainly physiotherapeutic, sterilizing and surgical appliances and dental mechanicalequipment is manufactured. However, within the country there are no producers of measuringinstruments subject to legal control and used in the healthcare sector.

3.3. Importers

The measuring instruments used in the healthcare sector in Bulgaria are imported from the EUMember States as well as other countries like China, Russia, Japan, Singapore, etc.

The established trend for import of a great number of clinical thermometers and blood pressuremeters from Russia and China still continues - about 90 %. Usually, these measuringinstruments do not bear the conformity marking and that is why according to the Law onMeasurements they are subject to type approval examination, initial and subsequentverifications.

The above mentioned imposes the carrying out of mandatory metrological control of measuringinstruments used in health care in the next few years.

4. Unsatisfied needs

4.1. Equipment

According to the Law on Measurements SAMTS carries out the control of medical devices withmeasuring functions, with the exception of clinical dosimeters. This control includes typeapproval, an initial verification and subsequent verifications and it is in force for all types ofmeasuring instruments subject to legal control.

For the purpose of this control DG "MMI" has at its disposal testing and verificationlaboratories for type approval and verification of medical devices with measuring functions. 28types of sphygmomanometers, 34 types of clinical thermometers and 25 types ofelectrocardiographs have been approved.

46

Annually in the laboratories of the 16-th regional departments of DG "MMI" 2000 clinicalthermometers, 18 000 sphygmomanometers and 2 000 electrocardiographs are verified. Theannual number of medical devices with measuring functions subject to subsequent verificationsis approximately two times greater than the number of these verified per year. At present thelaboratories have no technical capacity to carry out the necessary number of verifications peryear because of technical obsolescence of the available equipment.

Information on the equipment available in the laboratories as well as on the one that isnecessary for the carrying out of metrological control is given in Table I.

The condition of the equipment in the laboratories for carrying out control of clinicalthermometers and focimeters is as follows:• The standard thermometers were supplied in 1979. In some of the laboratories they are

broken and somewhere they are unusable due to a change in the metrological characteristicsor breaking of the mercury column;

• The thermostats do not have the necessary stability due to technical obsolescence;• There is a centrifuge in only one laboratory, which is also technically obsolete and have

undergone numerous repairs;• Digital ohmmeter and resistance decades for control of clinical electrical thermometers are

missing;• The two sets of test lenses (Russian manufacturing) and the focimeter AUS of Jena (former

DDR) were supplied in the 1970s and make the measurements difficult and inefficient. Thelatter is almost completely out of use.

In the laboratories for carrying out control of sphygmomanometers, the pressure balances weresupplied more than 20 years ago. They do not ensure the necessary time for maintenance of thepre-set pressure values in spite of the frequent repairs. Measurement standards for control ofautomated sphygmomanometers are missing.

There is one laboratory for verification of audiometers in the country. Currently, a smallnumber of audiometers are verified in this laboratory because of its limited technical capacity.The equipment in this laboratory is also technically obsolete, very often it causes defects andinaccuracies in measurements and control. The establishment of a mobile laboratory isnecessary for the purpose of performing verifications on the territory of the whole country.

So far, the metrological control of optical medical devices was not applied except in the cases ofcustomers' desire. The number of these voluntary verifications per year currently is about 80.According to the Law on Measurements these devices, following the OIML recommendations,have been included in the legally controlled group of measurements. Considerable increase ofcustomers' applications is expected as from the current year. The available equipment capacitycan not meet the expected demand due to its extremely low efficiency. On the other hand, itsmetrological characteristics is too poor to allow a type approval examination for devicesimported from the countries like China, Russia, Japan, Singapore, etc.

4.2. Training of personnel

- Introducing the European practice in the field of metrological control of measuringinstruments used in health care;

47

- Technical assistance in the assessment of the administrative, technological and technicalcapacity of the laboratories;- Assistance in the development of the strategy for improvement of the metrologicalactivities related to measuring instruments used in health care;- On-the-job training of DG “MMI” experts in order to increase the efficiency of themetrological control carried out.

The analysis of activities and technical capacity for their implementation shows that DG "MMI"has no capability to perform verifications of medical devices with measuring functions. It isnecessary new and state-of-the-art equipment to be supplied for the purpose of carrying outeffective control of medical devices with measuring functions.

48

Table I Necessary and available equipment for carrying out metrological control ofclinical thermometers, sphygmomanometers, audiometers and focimeters

Type of measuringinstruments;

OIMLRecommendations;

Controlledcharacteristics

Necessary equipment forcarrying out of control

Available equipment forcarrying out of control

Equipment necessary to besupplied

Clinical thermometers,mercury-in-glass withmaximum device -OIMLRecommendation R 7:1. Maximum errors in theindications of thethermometer:• +0,10 °?• -0,15 °?

2. Check of themaximum deviceoperation.

1.1. Standard mercury-in-glassthermometers with measuringranges from 30 °? to 40 °? andfrom 40 °? to 50 °? and scaledivision 0,02 °C;

1.2. Liquid thermostat withstability 0,01 °? ;

1.3. Stopwatch with scaledivision 0,2 s and accuracy 0,4s;

2. Centrifuge providing radialacceleration 600 m/s2.

1.1. Standard mercury-in-glass thermometers withmeasuring ranges from 30°? to 40 °? and from 40 °?to 50 °? and scale division0,02 °C - supplied in 1979.

1.2. Water thermostat withstability 0,01 °? ;

-

2. Centrifuge providingradial acceleration 600 m/s2;

- there is a centrifuge in onlyone laboratory.

1.1. Standard mercury-in-glass thermometers withmeasuring ranges from 30°? to 40 °? and from 40 °?to 50 °? and scale division0,02 °C;


1.3. Stopwatch with scaledivision 0,2 s and accuracy0,4 s;

2. Centrifuge providingradial acceleration 600 m/s2

Clinical electricalthermometers – R 114,R 115:1. Probe:1.1 Maximum errors:for class ? ± 0,10 °?for class ?I ± 0,10 °?

2. Reading device:2.1. Maximum errors:for class ? ± 0,05°?for class ?I ± 0,10°?

3.Compactthermometers:3.1. Maximum error:for class ? ±0,15 °?

1.1. Digital ohmmeter withmeasuring ranges 10 O; 100 O;1 kO; 10 kO; 100 kO; 1 ? O,resolution 6 ½ digits andaccuracy 20 ppmR + 10 ppmFS;


2.1. Resistance decades withmeasuring ranges 10 O; 100 O;1 kO; step 0,001 O andaccuracy 0,004 O.

3.1. Standard mercury-in-glassthermometers with measuringranges from 30 °? to 40 °? andfrom 40 °? to 50 °? and scale

-

1.2. Water thermostats

-

3.1. Standard mercury-in-glass thermometers withmeasuring ranges from 30°? to 40 °? and from 40 °?

1.1. Digital ohmmeter withmeasuring ranges 10 O; 100O; 1 kO; 10 kO; 100 kO; 1? O, resolution 6 ½ digitsand accuracy 20 ppmR + 10ppmFS;


2.1. Resistance decades withmeasuring ranges 10 O; 100O; 1 kO; step 0,001 O andaccuracy 0,004 O.

3.1. Standard mercury-in-glass thermometers withmeasuring ranges from 30°? to 40 °? and from 40 °?

49

for class ?? ±0,20 °? division 0,02 °C;

3.2. Liquid thermostat withstability 0,01 °? .

to 50 °? and scale division0,02 °C;

3.2. Water thermostats

to 50 °? and scale division0,02 °C;

3.2. Liquid thermostat withstability 0,01 °? .

Sphygmomanometers:OIML RecommendationR16.1. MechanicalMeasuring range:Lower value – 0,4 k??/3mmHg/Upper value – 40 k??/300 mmHg/Scale division – 0,2k??/2 mmHg/

Permissible error - ± 0,5k??/±4 mmHg/

2. Automated

1. Standard manometer up to40 k??/300mmHg/

and uncertainty U= ± 0,05.

2. Generator and analyser ofpulse waves up to 40k??/300 mmHg/ anduncertainty U= ± 0,1 k??.

1. Pressure balance MP-0,4up to 40 k??/300 mmHg/ and uncertainty U= ± 0,05.

-

1. Standard manometer up to40 k??/300 mmHg/ and uncertainty U= ± 0,05.

2. Generator and analyser ofpulse waves up to 40k??/300 mmHg/ anduncertainty U= ± 0,1 k??.

Audiometers:OIML RecommendationR 122.

1. Simple (125-4000) Hz (0-130) dB

2. Combined (125-8000) Hz (0-130) dB

1. Module precise soundanalyser in real time mode withbuilt-in octave filters with basesoftware – type 2260 A; 2. Adapter – type DB0375; 3. Adapter – type JJ2617; 4. Capacity microphone – type4144; 5. Artificial ear – type 4152; 6. Artificial mastoid – type4930; 7. Acoustic calibrator – type4231.

From the former company“Robotron” - Germany: 1. Analogue-digitalanalyser type - 52003;

2. Terzoctave filter- type01018.

From the company “Brüel& Kjær” – Denmark:

1. Artificial ear – type4152; 2. Artificial mastoid – type4930;

1. Module precise soundanalyser in real time modewith built-in octave filterswith base software – type2260 A; 2. Adapter – type DB0375; 3. Adapter – type JJ2617; 4. Capacity microphone –type 4144; 5. Artificial ear – type4152; 6. Artificial mastoid – type4930; 7.Acoustic calibrator – type4231.

Focimeters:OIML RecommendationR 93.

FocimetersRef.: Table 1, 2 3 and 4of the OIMLRecommendation R 93

1. Standard focimeter: 2 pieces

Measuring range:1. Sphere Power: 0 - ±25 D;steps (0,01/0,125/0,25 D);2. Cylinder Power: 0 - ±25 D;steps (0,01/0,125/0,25 D);3. Cylinder Axis: 0 º - 180 º;step 1 º;4. Prism Power: 0 ? - 20 ?;steps (0,01/0,125/0,25 ?);5. Prism base: 0 º - 360 º; step 1º

Two sets of test lenses,manufactured by VNIIM "D.I. Mendeleev" in Russia,each comprising of 12 lensesand 4 prisms,± 0,5, ± 1,5, ± 4, ± 8, ± 14and ± 20 D, supplied in1976, which are obsolete.Focimeter AUS - Carl Zeiss- Jena, (former DDR) out ofuse because of obsolescence.

1. Standard focimeter: 2pieces

Measuring range:1. Sphere Power: 0 - ±25 D;steps (0,01/0,125/0,25 D);2. Cylinder Power: 0 - ±25D; steps (0,01/0,125/0,25D);3. Cylinder Axis: 0 º - 180 º;step 1 º;4. Prism Power: 0 ? - 20 ?;steps (0,01/0,125/0,25 ?);

50

Tolerances according to Tables1 and 2 of Annex 5.2. Two sets of at least 20 testlenses each, for focimetersverification purposes,comprising of:± 1, 2, 5, 10, 15, 20, 25 D,diameter 40 mm, and2, 5, 10, 15, 20 ?; dimensions40 x 40 ± 0,2 mm.Tolerances according to Tables3 and 4 of Annex 5.

5. Prism base: 0 º - 360 º;step 1 ºTolerances according toTables 1 and 2 of Annex 5.2. Two sets of at least 20 testlenses each, for focimetersverification purposes,comprising of:± 1, 2, 5, 10, 15, 20, 25 D,diameter 40 mm, and2, 5, 10, 15, 20 ?;dimensions 40 x 40 ± 0,2mm.Tolerances according toTables 3 and 4 of Annex 5.

51

ANNEX 3

REQUIREMENT EQUIPMENT SPECIFICATION FOR LIQUID FUELS TESTINGLABORATORIES - Component 1: Supply of Equipment for Directorate General“Quality Control of Liquid Fuels”

?. Stationary Laboratory in Sofia

No Description of the device and the testmethod

Prescribed in Approximateprice in €

1. Equipment for atomic absorptionspectroscopy for evaluation of-lead in fuels according to EN 237

Pr EN 14274:2001EN 228

120 000

2. Dispersive X-Ray Fluorescencespectrometer for evaluation of S in fueland diesel according to EN ISO 14596

Pr EN 14274EN 228EN 590

60 000

3 Equipment for evaluation of the cetanenumber for diesel fuel according to ENISO 5165:98

Pr EN 14274

EN 590

250 000

4 Equipment for high performance liquidchromatography for evaluation of thepolynuclear aromatics in diesel fuelaccording EN 12 916

EN 590 100 000

5 Equipment for evaluation of the lubricityfor diesel fuels according to EN ISO12156

EN 590 50 000

6 Semi-automatic bomb calorimeter forevaluation of the heat of combustibilityfor diesel domestic heating fuels

ISO 1928 20 000

7 Centrifuge for evaluation of water andsediments contents of heating fuels forboilers

10 000

Total for the stationary laboratory in Sofia610 000

II. 2 mobile laboratories with the following equipment in each laboratory:

1. Equipment for evaluation of thedistillation characteristics of fuels anddiesel according to EN ISO 3405

pr EN14274:2001EN 228EN 590

60 000

2. Equipment for X-ray fluorescenceevaluation of Pb in fuels and S in fuelsand diesels according to EN

EN 228EN 590

45 000

52

3 Equipment for evaluation of Reid vaporpressure of fuel according to EN 13016-1

EN 228 20 000

4 Equipment for evaluation of Cold filterplugging point of diesels according to EN116

EN 590 20 000

5 Equipment for evaluation of density ofdiesel fuel at 15°C according to EN ISO3675

EN 590 15 000

6. Pick up car 50 000

Total for 2 mobile laboratories 420 000

III. IT equipment

1. Server – processor 2x Intel Pentium IVcompatible, RAID, HDD 1x20 GB +3x20 GB, RAM 1.5 GB, CD-RW, Back-up device 24 GB, network modem,15”monitor, keyboard, mouse

1 unit4 000

2. Work Station – processor 1 GHz, HDD20 GB, 256 MB RAM, FDD – 3,5”, LANcard 10/100 Mb, CD-ROM, 17” monitor,keyboard, mouse

5 units 5 000

3. Printer – network laser printer, double-sided, A4, Black & White

3 units 3 000

4. Basic and application software for themonitoring system

53 000

5. UPS – 3 kWA, 120 min – load; InputVolt 187-285 VAC 1 phase, Output – 220VAC 1 phase

6 units 3 000

6. Network connection 2 000Total for the IT system 70 000

53

ANNEX 4

REQUIREMENT EQUIPMENT SPECIFICATION FOR TESTING LABORATORYFOR LIQUID FUEL FLOWMETERS - Component 2: Supply of Equipment forDirectorate General “Measures and measuring Instruments” - Flow Rate MeasurementLaboratory

Laboratory

Testing laboratory for liquid fuel flowmeters

The laboratory is intended for testing of liquid fuel flowmeters, fuel and gas dispensersaccording to:- OIML R 117 Measuring systems for liquids other than water- OIML R 118 Testing procedures and test report format for pattern evaluation of fuel

dispensers for motor vehicles- Directive 71/319/EEC on meters for liquids other than water- Directive 77/313/EEC on measuring systems for liquids other than water

Testing rig

- Maximum flowrate Qmax = 500 l/min- Minimum flowrate Qmin = 1 l/min- Uncertainty U = ± 0,1 %- Standard balance up to 15 kg, repeatability 0,006 g- Standard balance up to 60 kg, repeatability 0,03 g- Standard balance up to 150 kg, repeatability 0,15 g- Density transducer for liquids with a measuring range from 0,6 g/cm³ to 1,6 g/cm³, for

pressure up to 20 bar, uncertainty U = ± 0,001 g/cm³- Viscosity transducer for liquids with a measuring range up to 100 mPa.s, uncertainty

U = ± 1 %- Temperature transducer for liquids with a measuring range from minus 25 °C to 55 °C,

uncertainty U = ± 0,1 °C- Flowrate transducers with a flowrate from Qmin = 1 l/min to Qmax = 500 l/min, uncertainty

U = ± 0,1 %- Mass flowmeters with a flowrate up to Qmax = 50 l/min, 100 l/min and 500 l/min,

uncertainty U = ± 0,1 %- Pump for flowrates up to 500 l/min- Correction device for density and temperature of the liquid- Time measuring and correction device for the transitional process, uncertainty U = ±0,01 s- Flowrate calculation device- DC Voltmeter up to 40 V, uncertainty U = ± 0,02 %- Electronic stop-watch, uncertainty U = ± 0,1 s- Hygrometer for relative humidity up to 90 %, uncertainty U = ± 3 %- Liquid-in-glass thermometers for temperatures from 10 °? to 40 °?, uncertainty U = ± 0,2 °?

54

Auxiliary devices

- Main tank for the working liquid with capacity 10 m³- Precise flowrate regulators for a flowrate from Qmin = 1 l/min to Qmax = 500 l/min- Precise flowrate stabilizer- Gas separator- Diversion device - flow diversion time from 0,1 s to 1 s- Pipelines, taps and connection devices for pressure up to 1 ? ??- Computer for processing and calculation of testing results, printer and scanner- Stabilized rectifier up to 24 V- System for cyclic load of fuel and gas dispensers- 8-channel measuring system for temperatures from 10 °? to 40 °?, uncertainty U = ± 0,1 °?- Bottle for pressurized nitrogen with pressure 15 ? ??- Reduction valves for outlet pressure 1 ? ??- Microscope for measuring the scale marks' width

Mobile Verification Laboratory for Fuel and Gas Dispensers

Verification Equipment

- Small-displacement motor vehicle- Standard metal measure for liquefied gas with capacity 25 l, uncertainty U = ± 0,02 %- Standard metal measure for liquefied gas with capacity 25 l, uncertainty U = ± 0,04 %- Standard metal measure for verification of fuel dispensers with capacity 10 l, uncertainty

U = ± 0,04 %- Standard metal measure for verification of fuel dispensers with capacity 20 l, uncertainty

U = ± 0,04 %- Standard metal measure for verification of fuel dispensers with capacity 50 l, uncertainty

U = ± 0,04 %- Areometers for liquefied gas fitted with thermometer, scale division 0,0005 g/m³ and

ranges from 0,5 g/cm³ to 0,55 g/cm³; from 0,55 g/cm³ to 0,60 g/cm³, from 0,60 g/cm³ to0,65 g/cm³

Calibration standards

- Standard metal measure for verification of fuel dispensers with capacity 10 l, uncertaintyU = ± 0,02 %



- Standard metal measure for liquefied gas with capacity 25 l, uncertainty U = ± 0,02 %- Standard metal measure with capacity 250 l, uncertainty U = ± 0,02 %

Total equipment price: EURO 1 300 000

55

ANNEX 5

REQUIREMENT EQUIPMENT SPECIFICATION FOR MEDICAL DEVICES WITHMEASURING FUNCTIONS - Component 3: Supply of Equipment for DirectorateGeneral “Measures and measuring Instruments”

Ø Standards and technical equipment for 4 laboratories for type approval andverification of clinical thermometers

I. Clinical liquid-in-glass thermometers:

1. Standards:Liquid-in-glass thermometers: measuring range (30-50) °C and scale division 0,02 °C;

2. Technical equipment:2.1. Water bath with stability 0,01 °C;2.2. Centrifuge providing radial acceleration 600 m/s2;

2.3. Stopwatch with scale division 0,2 s and accuracy 0,4 s;

II. Clinical electrical thermometers:

1. Standards:1.1. Digital ohmmeter with measuring ranges 10 O; 100 O; 1 ?O; 10 ?O; 100 ?O; 1 ? O,

resolution 6 ½ digits and accuracy 20ppm R + 10ppm FS.1.2. Resistance decades with measuring ranges10 O; 100 O; 1 ?O; step 0,001 O and

accuracy 0,004 O.

Total equipment price: EURO 380 000

Ø Equipment for testing and verification laboratories for blood pressure measuringinstruments

1. Equipment for testing of blood pressure measuring instruments (sphygmomanometers) up to40 kPa in accordance with OIML Recommendations R 16-1 "Non-invasive mechanicalsphygmomanometers" and R 16-2 "Non-invasive automated sphygmomanometers"

2. Equipment for verification of blood pressure measuring instruments up to 40 kPa – up to 10pieces:- standard manometer: measuring range up to 40 kPa;- generator and analyser of pulse waves: measuring range up to 40 kPa

2. Equipment for verification of blood pressure measuring instruments up to 40 kPa:- standard manometer: measuring range up to 40 kPa - up to 10 pieces;- generator and analyser of pulse waves: measuring range up to 40 kPa - up to 5 pieces.


56

Ø Equipment for acoustic values measurement for mobile laboratory

1. Module precise sound analyser in real time mode with built-in octave filters with baseinside software, type 2260? - 1 piece

Technical parameters:- Frequency range (16 ÷ 12500) Hz- Dynamic range (20 ÷ 140) dB- Built-in filters – ?, ? and Lin- Octave and 1/3 octave filters – (16 ÷ 12500) Hz

2. Adapter – type DB0375 - 1 piece

3. Adapter – type JJ2617 - 1 piece

4. Capacity microphone, type 4144 -1 piece

Technical parameters:- Frequency range (2,6 ÷ 8000) Hz- Sensitivity 50 mV/Pa- Upper limit of dynamic range 146 dB against 2.10-5 Pa- Polarization voltage 200 V- Resonance frequency 8000 Hz- Temperature coeficient in period (-50 ÷ +80)°? – 0,008 dB/°?

5. Artificial ear, type 4152 - 1 piece

Technical parameters:- Frequency range (3,9 ÷ 20000) Hz- Sensitivity 12,5 mV/Pa- Resonance frequency 23000 Hz- Acoustic connection chambers 2.10-6 and 6.10-6 m³

6. Artificial mastoid , type 4930 - 1 piece

Technical parameters:- Frequency range (50 ÷ 10000) Hz- Sensitivity related to charge and acceleration 2 pC/ms ²̄- Sensitivity related to voltage and acceleration –63 dB against 1 V/ms ²̄ per 1000 Hz- Sensitivity related to charge and power 300 pC/g

7. Acoustic calibrator – type 4231 - 1 piece

Technical parameters:- Frequency 1000 Hz ±1,5%- Sound pressure level 94 and 114 dB ± 0,2 dB against 2.10-5 Pa- Distortion < 1%- Static pressure influence at 100 Pa - ±0,05 dB in range 0–50 °?

57


Ø Equipment for optical measurements laboratory

1. Standard focimeter: 2 pieces• Measuring range:

- Sphere Power: 0 - ±25 D; steps (0,01/0,125/0,25 D);- Cylinder Power: 0 - ±25 D; steps (0,01/0,125/0,25 D);- Cylinder Axis: 0 º - 180 º; step 1 º;- Prism Power: 0 ? - 20 ?; steps (0,01/0,125/0,25 ?);- Prism base: 0 º - 360 º; step 1 º

• Permissible tolerances:

Table 1 Tolerances of measured vertex power

Measurement range of vertex powerm-1 (D)

Permissible Tolerancesm-1 (D)

< 0≥ - 5

> 0≤ + 5

± 0,01

< - 5≥ - 10

> + 5≤ +10

± 0,02

< - 10≥ - 15

>+10≤ +15

± 0,02

< - 15≥ - 20

>+15≤ +20

± 0,03

< - 20≥ - 25

> +20≤ +25

± 0,03

Table 2 Tolerances of measured prismatic power

Measurement range of prismaticpower

cm/m (?)

Permissible Tolerancescm/m (?)

> 0≤ 5

0,03

> 5≤ 10

0,05

> 10≤ 15

0,10

> 15≤ 20

0,15

> 20 0,20

• Technical requirements:

Measurable lens size from 7 mm to 100 mm and thickness up to 20 mm.

58

Power supply 220 V ± 10 %; frequency 50 Hz ± 1 %.

Measuring time - 0, 1 s on average;

Computer control; digital display

2. Two sets of at least 20 test lenses each, for focimeters verification purposes, comprising of:

± 1,2, 5, 10, 15, 20, 25 D, diameter 40 mm, and2, 5, 10, 15, 20 ?; dimensions 40 x 40 ± 0, 2 mm.

Table 3 Tolerances for spherical test lenses:

Nominal back vertex powerm-1 (D)

Tolerances (maximumdeviation)

m-1 (D)-25 0,03-20 0,02-15 0,02-10 0,01-5 0,01+5 0,01+10 0,02+15 0,02+20 0,03+25 0,03

Table 4 Tolerances for prismatic test lenses

Prismatic deviationcm/m (?)

Tolerancecm/m (?)

2 ± 0,025 ± 0,0310 ± 0,0515 ± 0,1020 ± 0,15


59

ANNEX 6

Technical Specification for Metrology Equipment for Thermophysics MeasurementsLaboratory Component 4: SUPPLY OF EQUIPMENT FOR DIRECTORATEGENERAL “NATIONAL CENTRE OF METROLOGY” – “THERMOPHYSICSMEASUREMENTS LABORATORY”

GENERAL REQUIREMENTS

The Tenderer shall meet the following general requirements to the metrology equipmentsupplied:

1. Maximum delivery period is eight months. Installation and putting into operation of allequipment to be concluded two months after delivery.

2. Warranty period shall be one year.3. The supplies shall include all accessories necessary for proper operation, such as, but not

limited to, power cables, interconnect cables, adapters, input devices, power adapters, mediaof all installed software.

4. The Tenderer shall provide consumables for start up and acceptance tests. The prices shallbe specified within the contract amount.

5. All equipment shall be in conformity with all applicable Bulgarian and EU technicalregulations. Evidence for compliance has to be provided (such as CE marking,manufacturer declaration, relevant marks/signs or copies of certificates) for suchequipment.

6. The Tenderer shall provide equipment technical documentation in English includingtechnical specification of manufacturer, manuals for equipment operation, reference booksetc.

7. The Tenderer shall provide a warranty for quality and performance of the goods supplied(Works Certificates/Product Certificates provided by the manufacturer)

8. CalibrationCalibration by a national metrology institute is to be offered for reference instruments,specified in the table Specific Requirements. The tenderer shall indicate the calibration costin EURO per item specified.

9. TrainingGeneral: Equipment use and operationParticular: Thermophysics measurements, test results and measurement uncertainty,

software applicationParticipants:

- Two NCM experts to be trained on realization of standard fixed point using deliveredcells. Metrologists from manufacturer or national metrology institute shall perform thetraining. The Tenderer shall offer a training schedule.- Two NCM experts to be trained on radiators use and operation - type of black body.Metrologists from manufacturer or from national metrology institute shall perform thetraining. The Tenderer shall offer a training schedule.- Location and duration: Shall be proposed by tenderer: one week at manufacturer and4-5 days at NCM site after setting up the equipment.

10. Travel and accommodation expenses related to the experts to be trained shall be specifiedwithin the contract amount.

60

The metrology equipment supply must be delivered to the following address:State Agency for Metrology and Technical SurveillanceMladost, Poligona2, General Ivan Kinov str.1784 Sofia, Bulgaria

61

SPECIFIC REQUIREMENTS

ItemNo.

Item MetrologicalSpecifications/Uncertainty/Ac

curacy/Class

Qty.

I. Standard fixed point cells according to ITS-90 for realising the national temperaturescale of the country

I.1. Triple point of Mercury (Hg) – one ampoulerealizing triple point of Mercury

T= 234,3156 Ku = ± 0,5 mK99, 9999 % purity

1

I.2. Triple point of water (H2O) - an apparatusrealizing the triple point of water with threeampoules and ice mantle makerCalibration certificate for the three ampoulesby a national metrology institute

T= 273,16 Ku = ± 0,1 mK

1app.with

3amp.

I.3. Melting point of Gallium (Ga) - an apparatusrealizing the triple point of the Gallium withone ampouleCalibration certificate by a national metrologyinstitute

T = 29,7646 ºC u = ± 0,2 mK99, 9999 % purity

1

I.4. Freeze point of Indium (In) - one ampoule ofthe Indium

T = 156,5985 ºC u = ± 0,5 mK99, 9999 % purity

1

I.5. Freeze point of Tin (Sn) – one ampoule of theTin

T = 231,928 ºC u = ± 0,5 mK99, 9999 % purity

1

I.6. Freeze point of Zinc (Zn) – one ampoule ofthe Zinc

T = 419,527 ºC u = ± 1 mK99, 9999 % purity

1

I.7. Freeze point of Aluminium (Al) - oneampoule of the Aluminium

T = 660,323ºC u = ± 2 mK99, 9999 % purity

1

I.8. Freeze point of Silver (Ag)- one ampoule ofthe Silver

T = 961,78 ºCu = ± 2 mK99, 9999 % purity

1

I.9. Freeze point of Copper (Cu)- one ampoule ofthe Copper

T = 1084,62 ºCu = ± 5 mK99, 9999 % purity

1

I.10 Low temperature bath with holder forMercury fixed point cell

Temperature range: from 0 ºC tominus 50 ºC;

I.11. Medium temperature furnace for realizingthe fixed points of the In, Sn, and Zn withequalizing block for comparison calibration

Temperature range: from 150 ºC to500 ºC;

1

I.12. High temperature furnace for realizing thefixed points of the Al, Ag, and Cu withequalizing block for comparison calibration

Temperature range: from 200 ºC to1100 ºC;

1

62

I.13. Vertical annealing furnace for resistancethermometers with programmablecontroller with RS 232 interface

Temperature range: up to 1000 ºC;Display resolution: 0,1 ºC;Response: ± 0,3 ºC;Gradient: 0,3 ºC;Working space depth:Min. 500 mm;Internal diameter of the workingspace: Min. 40 mm

1

I.14. Software for interpolation and printing of data from calibration of standardPlatinum thermometers according to ITS-90

1

I.15. Windows based software for automation of the temperature calibration 1II. Set of standard Platinum resistance

thermometers according to ITS-90Nominal resistances at 0 ºC:25 O - 3 pieces100 O - 3 piecesCalibration certificates for the three PRT100 O by a national metrology institute

• Temperature ranges anduncertainties:

- from 84 K to 600 ºC; u = ± 2 mK;- from 0 ºC to 960 ºC; u= ±5 mK.• Reproducibility:from ± 1 mK to ± 2.0 mK• Relative resistance of the

thermometers:W (29,7646 ºC) = 1,11807W (-38,8344 ºC) = 0,844235W (961,78 ºC) = 4,2844• Method of connection: four-wire

Total6

PRT

III. Radiators - Type of black body Radiationsource, equalizing block for thermocouplesand black body with standard probe

• Range: from 150 ºC to 1 200 ºC;• Uncertainty, u: up to ± 4 K;• Internal diameter: Min. 50 mm.

1

IV. Standard automatic adiabatic bombcalorimeter for solid state materials andfluids

• Measurement range: from 0 J/g to30 000 J/g;

• Uncertainty: u = ± 0,05 J/g• Temperature measurement range:

from - 50 °C to 250 °C• Temperature uncertainty: u = ± 0,01 °C• Resolution: ± 0,001 °C• Temperature coefficient: 0,5

mK/°C• Method of connection: four-wire

1

V. Certified Reference Material for benzoicacid

• Uncertainty: ± 3 J / g to ± 5 J / g• Purity: Min. 0, 99999 mol / mol

1

63

VI. Standard stand for testing of complete heat meters 1Energy measurement standardPumpFlow stabilizerCoolerTemperature insulation

• Units of heat quantity - J, Wh• Flow rate: up to 30000 l / h• Temperature range: from 30 °C to

90 °C• Temperature difference: from 1 K

to 30 K• Uncertainty: u = 0,4 %• Technical capability for a

simultaneous measurement up tofive heat meters

• Technical capability for ameasurement of heat meters

with a conditional diameter• from DN 15 to DN 50

VII. Computer for automatic data processing andrelevant Software (see items I.14, and I.15)

• Processor 1 GHz• 256 MB RAM• HDD 40 GB/7200• FDD 1,44 MB• CD-RWR 40x• Video Card• 17 " Color Monitor: 1024 x 768 dpi 85 Hz refresh frequency 16 bit color• IEEE 488• Mouse PS/2 Optical Wheel• Sound Card + Speakers• Printer Laser A4, 600 dpi,

parallel interface (LPT)• Windows 98, Office 97 (or 2000)

1

VIII. System for calibration of thermometers, working in air environment and thermometers,measuring surface temperature within different temperature ranges

VIII.1. Calibrator for a temperature range from 150°C to 1200 °C in air environment withindication in Celsius degree, resolution0,1°C

• Working volume: Min. Ø 30 x 120mm

• Metal block insert with holes size: 8mm

• Absolute temperature stability: 0,2 °C

1

VIII.2. Portable digital thermometerCalibration certificate by a nationalmetrology institute

• Measured quantities: °C, K, O, µV• Temperature range: from - 200 °C to 850 °C (Pt 100); Resolution 0,001 K; Accuracy: from 0,01 to 0,05 K• Thermocouple types: B, C, D, E, J,

K, N, R, S, T Resolution 0,1 K;

1

64

VIII.3. Calibrator for temperature range fromminus 20 °C to 70 °C, relative humidityfrom 10 % to 90 %

• Absolute temperature stabilityinside the working volume:- ± 0,3 °C- Absolute humidity stability inside

the working volume: ± 1 %

• Technical capability for calibrationof thermometers having an externaldiameter up to Ø 300 mm andheight up to 80 mm

• Technical capability for visualreading of the thermometersindications

1

VIII.4. Ice generator 12 kg / 24 h 1

65

ANNEX 7

Implementation capacity report

The projects are implemented by the State Agency for Metrology and Technical Surveillance(SAMTS).

A Programme Implementation Unit (PIU) consisting of 6 persons is established within SAMTS.

The operational Programme coordination is carried out by the International Cooperation andEuropean Integration Directorate’s staff of the organisation. The personnel is trained in projectpreparation activities as well as have gained experience in various project implementation andcoordination (Phare and other donors projects).

The following is the institutional framework within which the project will have to operate:

Component 1: Technical Assistance for Directorate General “Quality Control of LiquidFuels” (DG “QCLF”) and Component 2: Supply of Equipment for Directorate General“Quality Control of Liquid Fuels”

The beneficiary in the field of quality control of liquid fuels is Directorate General “QualityControl of Liquid Fuels” within SAMTS. The basic obligation of the Directorate, stipulated inthe Rules of the organisational structure of SAMTS, are to monitor and control liquid fuels forwhich quality requirements are laid down in Directive 1999/32/EC and Directive 98/70/EC. TheDirectorate is organised in two units: "Testing of Fuels and Lubricants" Department and three“Quality Control of Liquid Fuels” Regional Departments situated throughout the country. Thenumber of their staff is 12 and 18 persons respectively. It is considered that the current staff ofthe Directorate is insufficient for carrying out of the foreseen control and testing activities. Atleast 10 people are necessary in addition.

Component 3: Technical Assistance for Fuel Flow Rate Measurement Laboratory,Component 4: Supply of Equipment for Fuel Flow Rate Measurement Laboratory,Component 5: Technical Assistance for Laboratories for metrological control of medicaldevices with measuring functions and Component 6: Supply of Equipment forLaboratories for metrological control of medical devices with measuring functions

The direct beneficiary of these Components is the Directorate General “Measures andMeasuring Instruments". The basic obligations of the Directorate, stipulated in the Rules of theorganisational structure of SAMTS, are to perform type examination, initial and subsequentverification of measuring instruments subject to metrological control. The Directorate isorganised in 16 regional departments all over the country. The total number of staff is 330.Three laboratories for type examination are in a process of preparation for accreditation underthe PHARE 2000 Programme, Project BG 0003.02.02 in order to meet coming requirements ofexpected CIML Mutual Acceptance Arrangement.

Legal metrological control assures accurate and reliable measurements for the purposes ofhealth care, public safety, environment protection, state and municipal receivables andcommercial payments.

DG “MMI” strives to achieve recognition of measuring instruments type approval and initialverification in order to support Bulgarian producers.

Component 7: Technical Assistance for Directorate General “Measures and measuringInstruments” (DG “NCM”) - Thermophysics measurements laboratory

66

The direct beneficiary of this Component is the Directorate General “National Center ofMetrology". The basic obligations of this Directorate, stipulated in the Rules of theorganisational structure of SAMTS, are to establish and develop the national measurementstandards, ensure traceability of the national measurement standards to the internationalmeasurement standards or to measurement standards of member-states of the MeterConvention, disseminate units of measurements, perform calibration and comparisons. The totalnumber of staff is 75. Since 2000 DG “NCM” has participated in the EUROMET activities.

67

ANNEX 8

Detailed Implementation Chart2004 2005 2006

J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A SComponent 1: TechnicalAssistance for DG “QCLF”A1.1 Staff training on specifictechnical and operational issuesrelated to implementation of theliquid fuels quality monitoringsystem (FQMS);A1.2 Consulting engineeringon customising applications andassistance to staff in putting intooperation of a computerisedmanagement system for liquidfuels quality control and relatedactivities;A1.3 Staff training on use ofthe IT-system;A1.4 Organisation andparticipation in internationalproficiency testing.Supply of Equipment for DG“QCLF”A1.5 Procurement ofequipment for testing of liquidfuels and its putting intooperation;A1.6 Procurement of IT-system hardware and softwareand their putting into operation.Component 2: TechnicalAssistance for DG “MMI” -Flow Rate MeasurementLaboratory

68

A2.1 Assessment andpreparation of recommendationsfor improvement of theadministrative and technicalcapacity for the implementationof New Approach Directive onMeasuring Instruments - Flowrate measuring instruments.A2.2 Training of staff onimplementation of the draft NewApproach Directive on MeasuringInstruments - Flow rate measuringinstruments - and respectiveWELMEC documents;A2.3 Training of staff onuncertainty budget of the testingprocedures.Supply of Equipment for DG“MMI” - Flow RateMeasurement LaboratoryA2.4 Procurement of fuel flowrate equipment, traceable tointernationally recognisedmeasurement standards, and itsputting into operation.Component 3: TechnicalAssistance for DG “MMI” -Laboratories for metrologicalcontrol of medical devices withmeasuring functions

A3.1 Workshop andintroduction of the EU practice inmetrological control of measuringinstruments used in health care;

69

A3.2 Assessment of theadministrative, technological andtechnical capacity of laboratoriesfor carrying out metrologicalcontrol of measuring instrumentsused in health care;A3.3 Elaboration of strategyfor development of metrologicalactivities regarding measuringinstruments used in health careafter the implementation of NewApproach Medical DevicesDirective;A3.4 Practical training in EUMember States on carrying outmetrological control of measuringinstruments used in health care.Supply of Equipment for DG“MMI”- Laboratories formetrological control of medicaldevices with measuringfunctionsA3.5 Procurement ofequipment for type examinationand initial verification ofmeasuring instruments used inhealth care, traceable tointernationally recognisedmeasurement standards, and itsputting into operation.

70

Component 4: Supply ofEquipment for DirectorateGeneral “National Center ofmetrology” (DG “NCM”) -Thermophysics measurementslaboratoryA.4.1 Procurement ofmetrology equipment forThermophysics laboratory,traceable to internationalmeasurement standards, and itsputting into operation.

Tendering, contracting

Implementation and disbursement

Disbursement and completion

71

ANNEX 9

Cumulative Contracting and Disbursement Schedule

All figures in €PLANNED

Jan.–March2004

April-June2004

July–Sept.2004

Jan.–March2005

April-June2005

July–Sept.2005

Oct.-Dec.2005

July–Sept.2006

TOTAL €4 477 000

Contract 1 Technical AssistanceInstitution BuildingContracted 400 000 400 000Disbursed 240 000 360 000 400 000 400 000

Contract 2 Supply (4 Lots, up to 4 contracts)InvestmentContracted 3 767 000 3 767 000Disbursed 3 390 300 3 767 000 3 767 000

National parallel co-financing (10%)Contracted 310 000 310 000

Disbursed 93 000 310 000 310 000

NB: In addition to the Phare funds the investment components of the project will receive co-financing from the State budget to the totalvalue of € 1 252 000 (35% of the total investment budget). 25% of the total investment budget is envisaged for joint co-financing ofequipment supply, which is reflected in the table above. The remaining 10% envisaged for renovation and refurbishment of laboratories(parallel co-financing) will be contracted according to the provisions of the Public Procurement Act.

72

ANNEX 10

RECONSTRUCTION WORKS AND REFURBISHMENT OF SAMTSLABORATORIES UNDER NATIONAL PARALLEL CO-FINANCING

Component 1: Directorate General “Quality Control of Liquid Fuels” Laboratory

1. Reconstruction works and refurbishment of the testing laboratory premises - € 42 0002. Ventilation of the testing laboratory premises - € 45 0003. Air conditioning of testing laboratory premises and of the storage premises of liquid fuelsamples in Regional Departments - € 10 0004. Laboratory facilities - € 10 0005. Environment monitoring system - € 3 000Total: € 110 000

Component 2: Directorate General “Measures and Measuring Instruments” - Flow RateMeasurement Laboratory

1. Reconstruction works and refurbishment of the premises - € 46 0002. Fire detection and fire extinguishing - € 20 0003. Air conditioning and ventilation - € 32 0004. Laboratory facilities - € 14 0005. Control and alarm system for maximum permissible benzene fume concentration and harmfulemissions - € 15 0006. Environment monitoring system - € 3 000Total: € 130 000

Component 3: Directorate General “Measures and Measuring Instruments" Laboratories

1. Reconstruction works and refurbishment of the premises - € 30 0002. Air conditioning - € 27 0003. Laboratory ancillary equipment - € 8 0004. Environment monitoring system - € 5 000Total: € 70 000

standard summary project fiche · the project purpose is to ensure effective and reliable liquid...

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