workshop para usuÁrios convênio fns/usp 2209/2008 … iso … · convênio fns/usp 2209/2008...
TRANSCRIPT
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WORKSHOP PARA USUÁRIOS
Convênio FNS/USP 2209/2008
Normas Técnicas, Gerenciamento de Risco,
Metrologia e Utilização de Produtos para a Saúde:
Porque participar e se envolver?
Profº Dr. José Carlos Teixeira de Barros Moraes Laboratório de Engenharia Biomédica/Escola Politécnica da USP
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Estrutura e estado atual da produção
normativa da ISO relativa a produtos para a
saúde
INTERNALIZAÇÃO BRASILEIRA DE NORMAS
TÉCNICAS NO SETOR DE PRODUTOS PARA A
SAÚDE
José Carlos T. B. Moraes
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ISO - International Organization for StandardizationSome examples of ISO technical committees
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ISO - International Organization for StandardizationSome examples of ISO technical committees
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ISO - International Organization for StandardizationHealth and Medicine ISO technical committees
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ISO - International Organization for StandardizationTC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use
TC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use
• Secretariat: DIN
• Secretary: Dr.-Ing. Vera Sattelmayer
• Chairperson: Dr. Bernd Mathieu (Germany) until end 2009
• Creation date: 1951
Scope:
Standardization of transfusion, infusion and injection equipment for medical and pharmaceutical use; terms
and definitions for such equipment; specifications for quality and performance of materials and components.
Standardization of containers (such as infusion bottles, injection vials, ampoules, glass cylinders, cartridges,
prefillable syringes, etc.) and devices (such as giving sets, blood collecting tubes, etc.) as well as pertinent
primary and secondary packaging and functional components (such as elastomeric closures, caps, pipettes
and accessories) for medical and pharmaceutical use.
Excluded:
• performance requirements of metered devices and supplies intended for self-administration of
medicinal products, non-prefilled syringes and needles and intravascular catheters, covered by ISO/TC 84;
• devices intended for respiratory therapy, covered by ISO/TC 121;
• dental cartridge syringe holder, covered by ISO/TC 106.
Total number of published ISO standards related to the TC and its SCs: 58
Number of published ISO standards under the direct responsibility of TC 76: 58
Participating countries: 17
Observing countries: 24
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ISO - International Organization for StandardizationTC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use
Subcommittee/Working Group Title
TC 76/WG 1 Plastic devices
TC 76/WG 2 Joint between ISO/TC 76 and ISO/TC 84: Glass
equipment
TC 76/WG 3 Secondary packaging closure components and
accessories
TC 76/WG 4 Elastomeric parts
TC 76/WG 5 Blood collection systems
TC 76/WG 6 Primary packaging materials for medicinal products
TC 76/WG 7 Non--electrically driven portable infusion devices
Joint working groups under the responsibility of another committee:
TC 84/WG 5 Joint TC 84-TC 76-TC 121/SC 3 WG : Pulmonary devices
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ISO - International Organization for StandardizationTC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use
Published standards
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ISO - International Organization for StandardizationTC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use
Published standards
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ISO - International Organization for StandardizationTC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use
Published standards
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ISO - International Organization for StandardizationTC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use
Published standards
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ISO - International Organization for StandardizationTC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use
Published standards
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ISO - International Organization for StandardizationTC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use
Published standards
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ISO - International Organization for StandardizationTC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use
Standards under development
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ISO - International Organization for StandardizationTC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use
Standards under development
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ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment
TC 121 - Anaesthetic and respiratory equipment
Secretariat: ANSI
Secretary: Ms. Debra Milamed
Chairperson: Dr. Ronald Greenbaum (United Kingdom) until end 2007
Creation date: 1966
Scope:
Standardization of anaesthetic and respiratory equipment and supplies, related devices and supply systems.
Total number of published ISO standards related to the TC and its SCs:
77
Participating countries:
26
Observing countries:
22
ISO committees in liaison:
TC 58, TC 198, TC 210, TC 215
IEC committees in liaison:
IEC/TC 62, IEC/SC 62D
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ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment
Subcommittee/Working Group Title
TC 121/CAGChairman Advisory Group
The convener can be reached through the secretariat
TC 121/SC 1 Breathing attachments and anaesthetic machines - STANDBY
TC 121/SC 2 Tracheal tubes and other equipment
TC 121/SC 3 Lung ventilators and related equipment
TC 121/SC 4 Anaesthesia terminology
TC 121/SC 6 Medical gas systems
TC 121/SC 8 Suction devices for hospital and emergency care use
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ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment
Published standards
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ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment
Published standards
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ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment
Published standards
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ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment
Published standards
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ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment
Published standards
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ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment
Published standards
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ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment
Published standards
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ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment
Published standards
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ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment
Standards under development
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ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment
Standards under development
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
TC 150
Implants for surgery
Secretariat: DIN
Secretary: Dr.-Ing. Gabriele Tröscher
Chairperson: Mr. J.P. Hallett (United Kingdom) until end 2010
Creation date:
Scope:
Standardization in the field of implants for surgery 1) and their requiredinstrumentation, covering
terminology, specifications andmethods of tests for all types of implants, and for thematerials
both basic and composite used in their manufactureand application.
1) Objects or devices which are surgically implantedin the body either temporarily or
permanently for diagnosticor therapeutic purposes.
Total number of published ISO standards related to the TC and its SCs: 126
Number of published ISO standards under the direct responsibility of TC 150: 10
Participating countries: 22
Observing countries: 19
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Subcommittee/Working Group Title
TC 150/WG 7
Fundamental standards
The convener can be reached through the
secretariat
TC 150/WG 8
Breast implants - STANDBY
The convener can be reached through the
secretariat
TC 150/WG 10
Data on implanted and retrieved devices
The convener can be reached through the
secretariat
TC 150/SC 1 Materials
TC 150/SC 2Cardiovascular implants and
extracorporeal systems
TC 150/SC 3 Neurosurgical implants
TC 150/SC 4 Bone and joint replacements
TC 150/SC 5 Osteosynthesis and spinal devices
TC 150/SC 6 Active implants
TC 150/SC 7 Tissue-engineered medical products
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgery
Published standards
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ISO - International Organization for StandardizationTC 150 - Implants for surgeryStandards under development
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ISO - International Organization for StandardizationTC 150 - Implants for surgeryStandards under development
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ISO - International Organization for StandardizationTC 150 - Implants for surgeryStandards under development
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ISO - International Organization for StandardizationTC 150 - Implants for surgeryStandards under development
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ISO - International Organization for StandardizationTC 157 - Mechanical contraceptives
TC 157 - Mechanical contraceptives
• Secretariat: DSM
• Secretary: Mrs. Roslina Harun
• Chairperson: Dr Eng Long Ong (Malaysia) until end 2011
• Creation date: 1974
Scope:
Standardization of mechanical contraceptives.
Total number of published ISO standards related to the TC and its SCs: 7
Number of published ISO standards under the direct responsibility of TC 157: 7
Participating countries: 25
Observing countries: 27
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ISO - International Organization for StandardizationTC 157 - Mechanical contraceptives
Subcommittee/Working Group Title
TC 157/TG 1 Statistical task group
TC 157/CAG Chairman Advisory Group
TC 157/WG 3 Intra-uterine devices
TC 157/WG 10 Minimum burst pressure and burst volume requirements
TC 157/WG 11 Packaging integrity
TC 157/WG 12 Determination of the amount of lubricant
TC 157/WG 13 Stability assessment
TC 157/WG 14 Guidance on the use of ISO 4074 and ISO 23409
TC 157/WG 15 Test methods for the effect of additional lubricants on physical
properties of condoms
TC 157/WG 17 Synthetic condoms
TC 157/WG 18 Female condoms
TC 157/WG 19 Methods for hole detection
TC 157/WG 20 Clinical trials
TC 157/WG 21 Determination of nitrosamines
TC 157/WG 22 Latex barrier membranes
TC 157/WG 23 Natural rubber latex condoms
TC 157/WG 24 Tubal ligation/Fallopian ring
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ISO - International Organization for StandardizationTC 157 - Mechanical contraceptives
Published standards
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ISO - International Organization for StandardizationTC 157 - Mechanical contraceptives
Standards under development
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ISO - International Organization for StandardizationTC 168 - Prosthetics and orthotics
TC 168 - Prosthetics and orthotics
• Secretariat: DIN
• Secretary: Dipl.-Ing. Karl Wenzelewski
• Chairperson: Prof. Dr. Manfred Nietert (Germany) until end 2010
• Creation date: 1977
Scope:
Standardization in the field of prosthetics and orthotics, covering such aspects as
performance, safety, environmental factors, interchangeability, etc.
Temporary and permanent procedures and devices are included.
Priority is given to standards on prostheses (artificial limbs and auxiliary equipment).
Total number of published ISO standards related to the TC and its SCs: 21
Number of published ISO standards under the direct responsibility of TC 168: 21
Participating countries: 16
Observing countries: 16
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ISO - International Organization for StandardizationTC 168 - Prosthetics and orthotics
Subcommittee/Working Group Title
TC 168/WG 1 Nomenclature and classification
TC 168/WG 2 Medical aspects
TC 168/WG 3 Testing
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ISO - International Organization for StandardizationTC 168 - Prosthetics and orthotics
Published standards
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ISO - International Organization for StandardizationTC 168 - Prosthetics and orthotics
Published standards
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ISO - International Organization for StandardizationTC 168 - Prosthetics and orthotics
Published standards
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ISO - International Organization for StandardizationTC 170 - Surgical instruments
TC 170 - Surgical instruments
• Secretariat: DIN
• Secretary: Dipl.-Ing. Karl Wenzelewski
• Chairperson: Prof. Bernd Domres (Germany) until end 2009
• Creation date: 1977
Scope:
Standardization in the field of surgical instruments such as forceps, scissors,
scalpels and retractors.
Excluded :
• specific instruments which are dealt with in ISO / TC 106 - Dentistry, and
ISO / TC 150 - Implants for surgery.
Total number of published ISO standards related to the TC and its SCs: 6
Number of published ISO standards under the direct responsibility of TC 170: 6
Participating countries: 8
Observing countries: 22
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ISO - International Organization for StandardizationTC 170 - Surgical instruments
Published standards
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ISO - International Organization for StandardizationTC 210 - Quality management and corresponding general aspects for medical devices
TC 210 - Quality management and corresponding general aspects for medical devices
• Secretariat: ANSI
• Secretary: Ms. Hillary Woehrle
• Chairperson: Dr. Eamonn V. Hoxey (United Kingdom) until end 2009
• Creation date: 1994
Scope:
Standardization of requirements and guidance in the field of quality management and corresponding general
aspects for medical devices. Standards for small bore connectors.
Excluded:
• generic quality management standards dealt with by ISO / TC 176;
• quality management standards for pharmaceutical products;
• technical requirements for specific types of medical devices (Note: Small bore connectors are
components of a range of medical devices but are not themselves medical devices).
Note:
In order to promote global harmonization the technical committee may also develop standards on general
aspects stemming from the application of quality principles to medical devices, where these are not covered
by the scope of another technical committee.
Total number of published ISO standards related to the TC and its SCs: 17
Number of published ISO standards under the direct responsibility of TC 210: 17
Participating countries: 30
Observing countries: 18
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ISO - International Organization for StandardizationTC 210 - Quality management and corresponding general aspects for medical devices
Subcommittee/Working Group Title
TC 210/WG 1 Application of quality systems to medical devices
TC 210/JWG 1 Joint ISO/TC 210-IEC/SC 62A WG : Application of risk
management to medical devices
TC 210/JWG 2 Joint ISO/TC 210-IEC/SC 62A WG : Medical device software
TC 210/WG 2 General aspects stemming from the application of quality
principles to medical devices
TC 210/WG 3 Symbols and nomenclature for medical devices
TC 210/JWG 3 Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability
TC 210/JWG 4 Joint ISO/TC 210-IEC/SC 62D: Small bore connectors
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ISO - International Organization for StandardizationTC 210 - Quality management and corresponding general aspects for medical devices
Published standards
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ISO - International Organization for StandardizationTC 210 - Quality management and corresponding general aspects for medical devices
Published standards
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ISO - International Organization for StandardizationTC 210 - Quality management and corresponding general aspects for medical devices
Standards under development
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ISO - International Organization for StandardizationTC 212 - Clinical laboratory testing and in vitro diagnostic test systems
TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
• Secretariat: ANSI
• Secretary: Mr. David Sterry
• Chairperson: Dr. Donald M. Powers (USA) until end 2012
• Creation date: 1994
Scope:
Standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems. This
includes, for example, quality management, pre- and post-analytical procedures, analytical performance,
laboratory safety, reference systems and quality assurance.
Excluded:
• generic quality management standards dealt with by ISO / TC 176;
• quality management standards for medical devices dealt with by ISO / TC 210;
• reference materials guidelines dealt with by the ISO Committee on Reference Materials
(REMCO);
• conformity assessment guidelines dealt with by the ISO Committee on Conformity assessment
(CASCO).
Total number of published ISO standards related to the TC and its SCs: 18
Number of published ISO standards under the direct responsibility of TC 212: 18
Participating countries: 32
Observing countries: 19
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ISO - International Organization for StandardizationTC 212 - Clinical laboratory testing and in vitro diagnostic test systems
Subcommittee/Working Group Title
TC 212/WG 1 Quality and competence in the medical laboratory
TC 212/WG 2 Reference systems
TC 212/WG 3 In vitro diagnostic products
TC 212/WG 4 Antimicrobial susceptibility testing
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ISO - International Organization for StandardizationTC 212 - Clinical laboratory testing and in vitro diagnostic test systems
Published standards
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ISO - International Organization for StandardizationTC 212 - Clinical laboratory testing and in vitro diagnostic test systems
Published standards
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ISO - International Organization for StandardizationTC 212 - Clinical laboratory testing and in vitro diagnostic test systems
Standards under development
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ISO - International Organization for Standardization
Fonte de pesquisa: http://www.iso.org