STANDARDIZATION OF NANOTECHNOLOGY

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1 STANDARDIZATION OF

2 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

3 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.

4 Two type of Standards Standards 1. Metrological standards: length, mass, time, quantity of matter primary and secondary standards 2. Written standards ISO 9001 and ISO ISO (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.

5 Standards can be: Standardization 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

6 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

7 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

8 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

9 India P-member National Technical Committee on Nanotechnology constituted by BIS(2007) Indonesia P-member Agency for National Standardization has established working team for nanotechnology Standardization TC Nanotech Iran P-member 3 nantional nanostandardisation committee (WG s) since Creating national database for nanotechnology standards and safety. Funding research programs on nanotechnology standardization and safety issues including master and PhD programs. Adopt 5 ISO documents Adopt 8 ISO documents ISIRI terminology and core terms in nanotechnology (In Farsi language) 9 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 Adopt 1 ISO documents Establishing Iran Nanometrology and Characterization Center (to be opened in 3 years) Adopt 3 ISO documents Nano-tree project in WG1 (ISO/TC229): final stage of NATIONAL WORKSHOP publishing. ON SRDCR& RMRDI IN AREA OF Developed a standard on toxicity evaluation May, of ZnO 2012 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 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 Establishing National Nano-product Risk Assessment Task Group. Published 4 National Standards 4 National Standards under developing Adopt 3 ISO documents

10 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)

11 Institutional Framework Standardization Policy & Regulatory Framework BSN Development of SNI BSN technical mgt TCs/STCs drafting of SNI Standard Society (MASTAN) enquiry & balloting Conformity Assessment KAN accreditation 3 rd Party CABs certification inspection testing calibration Technical Regulation Regulators Adoption of SNI into technical regulation BSN Notification body enquiry point NMI and Legal Metrology

12 Development of SNI Planning Drafting Enquiry Approval Proposals MASTAN Enquiry MASTAN e-balloting MASTAN Program Proposals TC Drafting TC/Sub-TC Final Drafting TC/Sub-TC Program Planning BSN Verification BSN Adoption & Publication BSN

13 List of nano standards (SNI) No Code Title Published 1 SNI ISO/TS :2011 Nanotechnologies - Vocabulary - Part 1: Core terms SNI ISO 29701:2011 Nanotechnologies Endotoxin test on nanomaterial samples for in vitro systems-limulus amebocyte lysate (LAL) test 3 SNI ISO/TS : 2011 Nanotechnologies -- Vocabulary -- Part 3: Carbon nano-objects SNI ISO/TR 11360:2011, Nanotechnologies -- Methodology for the classification and categorization of nanomaterials SNI ISO /TS 27687: : 2011 Nanotechnologies Terminology and definitions for nano-objects-nanoparticle,nanofibre and nanoplate 6 SNI ISO/TS 10867:2011 Nanotechnologies -- Characterization of singlewall carbon nanotubes using near infrared photoluminescence spectroscopy

14 List of nano standard in 2012 No Adoption Code Title Expected 1 ISO/TR 12885:2008 Nanotechnologies Health and safety practices in occupational settings relevant to nanotechnologies 2 ISO 10801:2010 Nanotechnologies-Genaration of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method 3 ISO 10808:2010 Nanotechnologies-Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing 4 ISO/TS 12805:2011 Nanotechnologies-Materials specificationsguidance on specifying nano-objects Publication date ISO/TS :2011 Nanotechnologies- Vocabulary- Part 4 : nanostructured materials ISO/TS : 2011 Nanotechnologies- Vocabulary- Part 5 : nano/bio interface ISO/TS : 2011 Nanotechnologies- Vocabulary-Part 7 : Diagnostics and therapeutics for healthcare 2012

15 STANDAR 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

16 AKREDITASI DAN PENILAIAN KESESUAIAN DI INDONESIA NATIONAL ACCREDITATION BODY OF INDONESIA (KAN) (ISO/IEC 17011) ACCREDITATION OF CERTIFICATION BODY ACCREDITAION OF LABORATORY ACCREDITAION OF INSPECTION BODY CERTIFICATION BODY TESTING/CALIBRATION LABORATORY ISO/IEC INSPECTION BODY ISO/IEC ISO/IEC ISO/IEC Guide 65 ISO/IEC ISO/IEC ISO/IEC Guide 65 MEDICAL LABORATORY ISO ISO/IEC PERSONNEL QMS CERTIFICATION CERTIFICATION PRODUCT CERTIFICATION EMS CERTIFICATION HACCP CERTIFICATION ECOLABEL CERTIFICATION PERSONNEL CERTIFICATE QMS CERTIFICATE PRODUCT CERTIFICATE EMS CERTIFICATE HACCP CERTIFICATE ECOLABEL CERTIFICATE TSTING/ CALIBRATION CERTIFICATE INSPECTION CERTIFICATE Standard Requirement ISO 9000 series Product Standard ISO Series SNI Standard Requirement Standard Metode Product Standard Requirement PERSONNEL PROFESSION SUPPLIERS/INDUSTRIES

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18 THANK YOU