standardization nanotechnology -...
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NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
STANDARDIZATION
OF NANOTECHNOLOGY
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
Why standards for nanotechnologies are important ?
• Standards will help to ensure that nanotechnology is
developed and commercialised in an open, safe and
responsible manner by supporting:
– safety testing, legislation and regulation
– worker, public and environmental safety
– commercialisation and procurement
– patenting
– communication about the benefits, opportunities and potential problems associated with nanotechnologies
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
Needs for standardization 1. To support commercialisation and market development
2. To provide a basis for procurement – technical/ quality/ environmental management
3. To support appropriate legislation/ regulation
Challenges: currently there are:
– No internationally agreed terminology/definitions for nanotechnology(ies).
– No internationally agreed protocols for toxicity testing of nanoparticles.
– No standardized protocols for evaluating environmental impact of nanoparticles.
– Existing “methods of test” may not be suitable for nanoscale devices and nanoscale dimensions.
– Measurement techniques and instruments need to be developed and/or standardized.
– New calibration procedures and certified references materials are needed for validation of test instruments at the nanoscale.
– Multifunction nanotechnology systems and devices will need new standards.
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
Standards • Two type of Standards
1. Metrological standards:
• length, mass, time, quantity of matter – primary and secondary standards
2. Written standards • ISO 9001 and ISO 14000
• ISO 26000 (Social Responsibility)
• SNI ( Indonesian Standard )
• To:
• support commercialisation and market development
• provide a basis for procurement based on technical requirements and quality/environmental management
• support appropriate legislation/ regulation .
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
Standardization
• Standards can be: – FORMAL – developed by independent experts working under the
auspices of a National, Regional or International standards body
• AFNOR, BSI, DIN, JIS, …………………
• CEN, CENELEC, …..
• ISO, IEC & ITU
– INFORMAL – developed by a SDO (Standards Development
Organisation)
• ASTM, IEEE, SAE, , VDI…
– PRIVATE – developed by a company or trade association
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
FORMAL standards are:
– PROPOSED, DEVELOPED AND APPROVED by the members
of the standards body
• Based on CONSENSUS
• STANDARD:
• Can be NORMATIVE, defining what MUST be done in e.g. a specific test method, or INFORMATIVE, providing information only.
• Standards are VOLUNTARY unless called in a contract or regulation
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
TC ISO 229
NANO TECHNOLOGY 4 Working Group:
1. WG1= Terminology
2. WG2= Metrology
3. WG3= Health, Safety
4. WG4= Material Spec
• 33 country P + 8 country O member.
• Indonesia as P member
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
Functions of standards
Standards can perform any of the following four functions:
1. Interoperability/Compatibility as with e.g. nuts and bolts, railway gauges, electrical plugs and outlets, and
interoperability standards for computers and telecommunications systems
2. Quality Fitness for purpose or safety
3. Variety reduction/optimization (based on best practice) E.g. shoe sizes, suit sizes – leading to mass production and price reduction
4. Information/Measurement Test and measurement methods for describing, quantifying and evaluating
product attributes such as material, processes and functions
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013 9
ANF Members
ISO TC229
Technical Standardization
Committee
Terminology &
Nomenclature
Measurement &
Characterization
Health, Safety &
Environment
India P-member • National Technical Committee on Nanotechnology constituted by BIS(2007)
Adopt 5 ISO documents
• Round-robin tests to be conducted to develop a standard for AFM characterization and evaluation of nanomaterials • Electron microscopic characterization of multiwalled carbon nanotube • Proposed to develop a standard on Luminescent Nanomaterials and Magnetic Nanoparticles
• Developed a standard on toxicity evaluation of ZnO nanomaterials • A Medical Biotechnology and Nanotechnology Sectional Committee constituted by BIS • Proposed to set up a regulatory board to examine nanotech products • Regulatory Framework, focused programmes in health and agriculture –ICMR, ICAR, DBT, DIT, BIS and several other Ministries, industry reps and other concerned parties • Adopt 2 ISO documents
Indonesia P-member •Agency for National Standardization has established working team for nanotechnology Standardization TC Nanotech
Adopt 8 ISO documents
Adopt 1 ISO documents
• Agency for Drug and Food Assessment begins considering nanotechnology application in drug and food fields • Succofindo (an institution for product certification) also begins considering nanotechnology enabled products • Adopt 4 ISO documents
Iran P-member • 3 nantional nano- standardisation committee (WG’s) since 2005. • Creating national database for nanotechnology standards and safety. •Funding research programs on nanotechnology standardization and safety issues including master and PhD programs.
• ISIRI 12098 terminology and core terms in nanotechnology (In Farsi language) • Nano-tree project in WG1 (ISO/TC229): final stage of publishing.
• Establishing Iran
Nanometrology and
Characterization
Center (to be opened
in 3 years)
• Adopt 3 ISO
documents
• Establishing National Nano-product Risk Assessment Task Group. • Published 4 National Standards • 4 National Standards under developing • Adopt 3 ISO documents
May, 2012
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
Legal Basis
Government Regulation 102/2000
• BSN is responsible to develop and promote national
standardization
• TCs for SNI development are established by BSN in
coordination with technical ministries and other relevant
government bodies
• The task of BSN in Conformity Assessment is delegated
to KAN (National Accreditation Body)
• Coordination with NMI and Legal Metrology is
implemented through KSNSU (Committee for National
Standard on Measurement Units)
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
Institutional Framework
NMI and Legal Metrology
Standard Society
(MASTAN)
enquiry & balloting
TCs/STCs
drafting of SNI
BSN
technical mgt
Development of SNI
3rd Party CABs
• certification
• inspection
• testing
• calibration
KAN
accreditation
Conformity Assessment
BSN
• Notification body
• enquiry point
Regulators
Adoption of SNI into
technical regulation
BSN
Technical Regulation
Standardization Policy & Regulatory Framework
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
Development of SNI
Planning Drafting Enquiry Approval
Program
Proposals
TC
Program
Planning
BSN
Drafting
TC/Sub-TC
Verification
BSN
Enquiry
MASTAN
e-Balloting
MASTAN
Adoption &
Publication
BSN
Final
Drafting
TC/Sub-TC
Proposals
MASTAN
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
List of nano standards (SNI)
No Code Title Published
1 SNI ISO/TS 80004-1:2011 Nanotechnologies - Vocabulary - Part 1: Core
terms
2011
2 SNI ISO 29701:2011 Nanotechnologies –Endotoxin test on
nanomaterial samples for in vitro systems-Limulus
amebocyte lysate (LAL) test
2011
3 SNI ISO/TS 80004-3: 2011 Nanotechnologies -- Vocabulary -- Part 3: Carbon
nano-objects
2011
4 SNI ISO/TR 11360:2011, Nanotechnologies -- Methodology for the
classification and categorization of nanomaterials
2011
5 SNI ISO /TS 27687: : 2011 Nanotechnologies –Terminology and definitions
for nano-objects-Nanoparticle,nanofibre and
nanoplate
2011
6 SNI ISO/TS 10867:2011 Nanotechnologies -- Characterization of single-
wall carbon nanotubes using near infrared
photoluminescence spectroscopy
2011
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
List of nano standard in 2012
No Adoption Code Title Expected
Publication
date
1 ISO/TR 12885:2008 Nanotechnologies – Health and safety practices
in occupational settings relevant to
nanotechnologies
2012
2 ISO 10801:2010 Nanotechnologies-Genaration of metal
nanoparticles for inhalation toxicity testing using
the evaporation/condensation method
2012
3 ISO 10808:2010 Nanotechnologies-Characterization of
nanoparticles in inhalation exposure chambers
for inhalation toxicity testing
2012
4 ISO/TS 12805:2011 Nanotechnologies-Materials specifications-
guidance on specifying nano-objects
2012
5 ISO/TS 80004-4:2011 Nanotechnologies- Vocabulary- Part 4 :
nanostructured materials
2012
6 ISO/TS 80004-5 :
2011
Nanotechnologies- Vocabulary- Part 5 : nano/bio
interface
2012
7 ISO/TS 80004-7 :
2011
Nanotechnologies- Vocabulary-Part 7 :
Diagnostics and therapeutics for healthcare
2012
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
Dokumen, yang berisi
spesifikasi teknis atau sesuatu yang dibakukan,
disusun berdasarkan konsensus oleh semua pemangku kepentingan
ditetapkan oleh lembaga berwenang,
dipergunakan secara umum dan berulang-ulang
untuk memperoleh tingkat keteraturan yang optimum
STANDAR
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
AKREDITASI DAN PENILAIAN KESESUAIAN DI INDONESIA
ACCREDITAION OF LABORATORY
TESTING/CALIBRATION LABORATORY
ISO/IEC 17025
MEDICAL LABORATORY
ISO 15189
ACCREDITAION OF INSPECTION
BODY
INSPECTION BODY
ISO/IEC 17020
ACCREDITATION OF CERTIFICATION
BODY
CERTIFICATION BODY
PERSONNEL CERTIFICATION
QMS CERTIFICATION
PRODUCT CERTIFICATION
HACCP CERTIFICATION
ISO/IEC 17024
ISO/IEC Guide 65
EMS CERTIFICATION
TSTING/ CALIBRATION CERTIFICATE
INSPECTION CERTIFICATE
HACCP CERTIFICATE
EMS CERTIFICATE
PRODUCT CERTIFICATE
PERSONNEL CERTIFICATE
Standard
Requirement
Standard
Metode
Product
ISO 14000
Series Standard
Requirement
ISO 9000
series
Product
Standard
SNI 01-4852-
1998
SUPPLIERS/INDUSTRIES PERSONNEL PROFESSION
NATIONAL ACCREDITATION BODY OF INDONESIA (KAN) (ISO/IEC 17011)
QMS CERTIFICATE
ECOLABEL CERTIFICATION
ECOLABEL CERTIFICATE
Standard
Requirement
ISO/IEC 17021
ISO/IEC 17021
ISO/IEC 17021
ISO/IEC Guide 65
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
tanda kesesuaian
NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF
NANOTECHNOLOGY
JAKARTA 26-27 JUNE - 2013
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