STANDARDIZATION NANOTECHNOLOGY -...

NATIONAL WORKSHOP ON SRDCR& RMRDI IN AREA OF

NANOTECHNOLOGY

JAKARTA 26-27 JUNE - 2013

STANDARDIZATION

OF NANOTECHNOLOGY


NANOTECHNOLOGY


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


NANOTECHNOLOGY


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.


NANOTECHNOLOGY


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 .


NANOTECHNOLOGY


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


NANOTECHNOLOGY


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


NANOTECHNOLOGY


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


NANOTECHNOLOGY


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


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



• 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


NANOTECHNOLOGY


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)


NANOTECHNOLOGY


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


NANOTECHNOLOGY


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


NANOTECHNOLOGY


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

http://sisni.bsn.go.id/index.php?/sni_main/sni/detail_sni_2/14030




NANOTECHNOLOGY


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


NANOTECHNOLOGY


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


NANOTECHNOLOGY


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

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//Bsn8.2/c/My Documents/KUKUH SA/COUNCIL-KAN/SLIDEShow/KANOverview.pps


NANOTECHNOLOGY


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NANOTECHNOLOGY


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