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Nanotechnology Standardisation

Nanotechnology Standardisation. M G Gee National Physical Laboratory BSI-Russia Workshop. Overview. Standards and standardization Role of standards Standardization organisations Development of formal standards Complementary structures Standardization for nanotechnologies

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Nanotechnology Standardisation

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  1. Nanotechnology Standardisation M G Gee National Physical Laboratory BSI-Russia Workshop

  2. Overview • Standards and standardization • Role of standards • Standardization organisations • Development of formal standards • Complementary structures • Standardization for nanotechnologies • What needs standardizing and why? • Current standardization committees • Existing standards, standardization projects and proposals • Cooperation, coordination and harmonization

  3. Standards • Standards can be of two types: • Metrological standards such as the kilogram or second • Written standards • Written Standards provide agreed ways of: • Naming, describing and specifying things • Measuring and testing things • Managing things e.g. quality and environmental management: ISO 9001 and ISO 14000 • Reporting things as in e.g. proposed ISO 26000 (Social Responsibility) • To: • support commercialisation, market development and established markets • provide a basis for procurement based on technical requirements and quality/environmental management • support appropriate legislation/regulation • 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. • Can provide a means of “validated quantification”

  4. Functions of Standards • Standards can perform any of the following four functions: • Interoperability/Compatibility • as with e.g. nuts and bolts, railway gauges, electrical plugs and outlets, and interoperability standards for computers and telecommunications systems • Quality • Fitness for purpose or safety • Variety reduction/optimization (based on best practice) • E.g. shoe sizes, suit sizes – leading to mass production and price reduction • Information/Measurement • Test and measurement methods for describing, quantifying and evaluating product attributes such as material, processes and functions • DIN has reported that in Europe standardization adds approximately 1% to the value of gross domestic product and that the added value generated by standardisation is at least as important as the value generated by patents! – see “Economic benefits of standardization” Published by DIN German Institute for Standardization e. V.

  5. 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, ………………… (NSBs) • CEN, CENELEC, ETSI….. • ISO, IEC & ITU • INFORMAL – developed by a SDO (Standards Development Organisation) • ASTM, IEEE, SAE, SEMI, VDI…(>600 SDOs IN US) • PRIVATE – developed by a company or trade association • FORMAL standards are: • PROPOSED, DEVELOPED AND APPROVED by the members of the standards body (or an accredited organisation) • Based on CONSENSUS (i.e. no sustained opposition) not necessarily unanimity.

  6. Needs for Standardization in Nanotechnology • To support commercialisation and market development • To provide a basis for procurement – technical/quality/environmental management • To support appropriate legislation/regulation Challenges: currently there are: • No internationally agreedterminology/definitionsfor nanotechnology(ies). • No internationally agreedprotocols for toxicity testing of nanoparticles. • Nostandardized protocols for evaluating environmental impactof nanoparticles. • Existing “methods of test” may not be suitablefor nanoscale devices and nanoscale dimensions. • Measurement techniques and instruments need to be developedand/or standardized. • Newcalibration procedures and certified references materials are neededfor validationof test instruments at the nanoscale. • Multifunctionnanotechnologysystems and devices will need new standards. Partial solutions • Some existing standards may be applicablee.g. for chemical analysis and imaging (ISO TCs 201 and 202) and particle detection/sizing (ISO TC 24)

  7. Major issues in Nanotechnology Standardisation • Diversity of disciplines impacted by and contributing to nanotechnologies • Global impact • Speed of development and apparent speed of commercialisation • Critical areas: • Coordination and harmonization across standards developers and stakeholders • Terminology • Measurement and characterization • Health, safety and environment

  8. 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 and IPR • communication about the benefits, opportunities and potential problems associated with nanotechnologies • This will be achieved by providing agreed ways of: • Naming, describing and specifying things • Measuring and testing things • Health and environmental safety testing, risk assessment and risk management

  9. International Organisation for Standardization committee ISO/TC 229 - Nanotechnologies • Established in June 2005 with UK Chair and Secretariat • 40 members – 30 “P” and 10 “O” (see http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=381983 ) • Liaisons with 15 other ISO TCs and 7 external bodies – IEC/TC 113, CEN/TCs 137 and 352, Asia Nano Forum, EC JRC, OECD and VAMAS • Exploring additional external liaisons for emerging economies • OECD liaison is particularly important as there is much work being carried out on EHS on manufactured nanoparticles

  10. International Electrotechnical Commission Committee IEC/TC 113 – “Nanotechnology Standardization for Electrical and Electronic Products and Systems” • Established June 2006 with US Chair and German secretariat • http://www.iec.ch/cgi-bin/procgi.pl/www/iecwww.p?wwwlang=e&wwwprog=dirdet.p&progdb=db1&css_color=purple&committee=TC&number=113 • 26 members - 15 “P” and 11 “O” • Agreed to establish two Joint Working Groups with ISO TC/229: • JWG 1 – Terminology and nomenclature • JWG2 – Measurement and characterization • Together with a third Working Group: • WG3 – PerformanceAssessment • Scope: To develop standards for the assessment of performance, reliability, and durability related to the nanotechnology-enabled aspects of components and systems in support of continuous improvement at all stages of the value adding chain. • Work Item: GUIDE FOR CARBON NANOTUBE SPECIFICATION FOR ELECTROTECHNICAL APPLICATION

  11. European Committee for Standardization Committee CEN/TC 352 - Nanotechnologies • http://www.cen.eu/CENORM/Sectors/TechnicalCommitteesWorkshops/CENTechnicalCommittees/CENTechnicalCommittees.asp?param=508478&title=CEN%2FTC+352 • Established November 2005 following proposal from UK and recommendations from CEN/BTWG 166 • UK Chair and Secretariat • Works closely with ISO/TC 229 and “topics of mutual interest will be developed under the ‘Vienna Agreement’ with ISO lead”. • Developing work programme in areas of specific interest to Europe and areas that will be relevant to European legislation. • Currently 3 projects: • Guide to nanoparticle measurement methods and their limitations (CEN/TR) • Guide to methods for nano-tribology measurements (CEN/TR) • Guide for Labelling of Engineered Nanoparticles and Products Containing Engineered Nanoparticles

  12. TC 229 – Structure/working Areas Terminology and Nomenclature (JWG 1) “what you call it” - Convened by Canada

  13. ISO/TC 229 JWG1: Strategic Roadmap Project 3 Nanomaterials classification Base Definitions Nanoscale Nano films Nano dispersions Terminology –carbon nanostructures Terminology – nano-bio interface Project 4 Nanoscale attribute Terminology - nanoparticles Project 1 Nomenclature- Model Options Nano-processes Nanoscale objects Nanostructured materials Nanotechnologies Nanomaterials Terminology - nanomaterials Nano-production Framework and core terms Project 2 Complex assemblies Terminology - nanostructures Terminology - nanofabrication Nomenclature model Nanomedical devices Nanosensors Nanomeasurement Devices and applications Terminology – medical and consumer Nanometrology Nanomeasurement tools Nanoelectronic devices Nanophotonic devices Terminology – nanoscalemeasurement (IEC) Vocabulary - electrotechnical (IEC) Terminology – nano-optics

  14. TC 229 – Structure/working Areas Terminology and Nomenclature (JWG 1) “what you call it” - Convened by Canada Measurement and Characterization (JWG 2) “How you measure/test it” – Convened by Japan

  15. ISO/TC 229 JWG2: Draft Roadmap 2005 2010 2015 Carbon Nano-Materials Basic Character set Purity Geometrical property Morphology Dispersability Tube type Advanced Character set Electrical, Magnetic, Mechanical , Optical properties Engineered nanoparticles Basic Character set Purity Composition, Geometrical property, Sampling method. Advanced Character set Elemental structure, Chemical functionality, Electrical, Magnetic, Mechanical , Optical properties Coatings/ Nanostructured materials Basic Character set Geometrical property, Composition, Density Advanced Character set Electrical, Magnetic, Mechanical , Optical properties Basic Metrology Length, Depth, Force, Traceability, Definition of Measurand, Uncertainty Interoperability Support for WG3 activities

  16. TC 229 – Structure/working Areas Terminology and Nomenclature (JWG 1) “what you call it” - Convened by Canada Measurement and Characterization (JWG 2) “How you measure/test it” – Convened by Japan Health, Safety and Environment (WG 3) “what effect it might have on health and the environment” – Convened by USA

  17. ISO/TC 229 WG3 : Strategic Roadmap Future Screening Test TBD Future Occupational Standards TBD In vivo Tox Test TBD In vitro Tox Test TBD Current Practices TR Metrology TBD Workplace Monitoring Terminology TBD Metrology TBD Terminology TBD Future NWIP TBD Nanoparticle Inhalation Testing Nanoparticle Toxicity Testing Sequence Physico-Chemical characterization Endotoxin Test Metrology TBD Terminology TBD 2008 2009 2010 2011

  18. TC 229 – Structure/working Areas Support for “REGULATION” and voluntary governance structures Material Specifications (WG4) (Convened by China) PRODUCT AND PROCESS (sc) PRODUCT AND PROCESS (sc) Terminology and Nomenclature (JWG 1) “what you call it” - Convened by Canada Measurement and Characterization (JWG 2) “How you measure/test it” – Convened by Japan Health, Safety and Environment (WG 3) “what effect it might have on health and the environment” – Convened by USA

  19. TC 229 Current Work Programme – JWG1 • ISO/TS: Terminology and definitions for nanoparticles - completed • ISO/TR: Terminology and nomenclature for nanotechnologies — Framework and core terms • ISO/TS: Terminology and definitions for carbon nanomaterials (Japan) • ISO/TS: Core Terms - Terminology and Definitions • New work item proposals: • ISO/TS: Terminology for nanoscale measurement and instrumentation • ISO/TS: Terminology for the bio-nano interface • ISO/TS: Terminology for medical, health and personal care applications of nanotechnologies • ISO/TS: Terminology for nanofabrication/nanomanufacturing • Committee resource document: • Outline of Nanomaterials classification ("Nano tree")

  20. TC 229 Work programme – JWG2 – SWCNT work • ISO/TS: The Use of Transmission Electron Microscopy (TEM) in the Characterizationof Single-walled Carbon Nanotubes (US/Japan) • ISO/TS: The Use of Scanning Electron Microscopy (SEM) and Energy Dispersive X-ray Analysis (EDXA) in the Characterization of Single-walledCarbon Nanotubes (US) • ISO/TS: Technical Specification for the Use of UV-Vis-NIR absorption spectroscopy in the Characterizationof Single-walledCarbon Nanotubes (Japan) • ISO/TS: Technical Specification for the use of NIR-Photoluminescence (NIR-PL) Spectroscopy in the Characterizationof Single-Walled Carbon Nanotubes(Japan) • ISO/TR: Use of Thermo Gravimetric Analysis (TGA) in thepurity evaluation of Single Walled Carbon Nanotubes (US/Korea) • ISO/TR: Use of Evolved Gas Analysis-Gas Chromatograph Mass Spectrometry (EGA-GCMS) in theCharacterization of Single-Walled Carbon Nanotubes (Japan) • ISO/TS: Use ofRaman Spectroscopy in the Characterization of Single Walled Carbon Nanotubes(US)

  21. JWG2 – MWCNT and Other Work • ISO/TS: Measurement Methods for the Characterization of Multi-Walled Carbon Nanotubes (Japan) • ISO/TS: Determination ofmeso-scopic shape factors of multiwalled carbon nanotubes (Korea) • ISO/IS: General Framework forDetermining Nanoparticle Content in Nanomaterials by Generation of Aerosols • Joint developments with CEN (CEN lead): • ISO/TR: Guide to nanoparticle measurement methods • ISO/TR: Guide to methods for nano-tribology measurements • NWIP under joint ballot: • Sample Preparation for 4-Probe Measurement of Electrical Properties of CNTs(Korea)

  22. TC 229 Work Programme – WG3 • ISO/TR: Safe Practices in Occupational Settings Relevant to Nanotechnologies – completed • Under CD ballot • ISO/IS: Endotoxin test on nanomaterial samples for in vitro systems • ISO/IS: Standard for Generation of Metal Nanoparticles with the Evaporation/Condensation Method for inhalation toxicity testing • ISO/IS: Standard for characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing • ISO/TR Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment. • New work item proposal: • Guide to safe handling and disposal of manufactured nanomaterials

  23. TC 229 Work programme – Materials specifications (WG4) • ISO/TS: Materials specification for nano-titanium dioxide • ISO/TS: Materials specification for nano-calcium carbonate • New Work Item Proposal • Guide to specifying nano-materials

  24. Current and potential liaisons for ISO/TC 229 ISO/TC 122 Packaging ISO/TC 206 Fine ceramics ISO/TC 217 Cosmetics ISO/TC 119 Powder metallurgy ISO/TC 215 Health Informatics ISO/TC150 Implants for surgery ISO/TC 172 Optics and photonics ISO/TC 84 Devices for administration of medical products and intravascular catheters ISO/TC 168 Prosthetics and orthotics ISO/TC 107 Metallic and other inorganic coatings ISO/TC 91 Surface active agents ISO/TC 61 Plastics ISO/TC 59 Building construction ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems ISO/TC 35 Paints and varnishes ISO/TC 225 Market opinion and social research ISO/TC 34 Food products ISO/TC 38 Textiles ISO/TC 215 Environmental management ISO/TC 28 Petroleum and petroleum products ISO/TC 180 Solar energy ISO/TC 184 Industrial automation systems and integration ISO/TC 203 Technical energy systems MATERIALS BIOMEDICAL EXTERNAL LIAISONS RISK/HS&E NANO-PARTICLES METROLOGY AND CHARACTERIZATION ISO/TC 48 Laboratory equipment ENERGY

  25. IEC/TC 110 Flat panel displays IEC/TC 105 Fuel cell technologies IEC/TC 86 Fibre optics IEC/TC 82 Solar photovoltaic energy systems IEC/TC 59 Performance of household electrical appliances IEC/TC 48 Electromechanical components and mechanical structures for electronic components IEC/TC 235 Primary cells and batteries IEC/TC 21 Secondary cells and batteries CURRENT AND POTENTIAL LIAISONS – IEC/TC 113 SEMI IEEE IEC/TC 34 Lamps and related equipment IEC/TC 113 Nanotechnology Standardization for electrical and electronic products and systems

  26. Complementary structures: e.g. OECD Test Guidelines for testing of chemicals • SECTION 1 - PHYSICAL-CHEMICAL PROPERTIES • SECTION 2 - EFFECTS ON BIOTIC SYSTEMS • SECTION 3 - DEGRADATION AND ACCUMULATION • SECTION 4 - HEALTH EFFECTS • For laboratories complying with “GLP”, “MAD” applies

  27. OECD WPMN Projects • Development of an OECD (Nanosafety) Database on Human Health and Environmental Safety (EHS) research • EHS Research Strategies on Manufactured Nanomaterials • Safety Testing of a Representative Set of Manufactured Nanomaterials • Manufactured Nanomaterials and Test Guidelines • Co-operation on Voluntary Schemes and Regulatory Programmes • Co-operation on Risk Assessments and Exposure Measurements • The Role of Alternative Methods in Nano Toxicology • Co-operation on Exposure Measurements and Exposure Mitigation

  28. Sponsorship programme for testing a “representative set” of manufactured nanomaterials • Fullerenes (C60) • Single walled carbon nanotubes • Multi walled carbon nanotubes • Carbon black • Nanoparticle (NP) silver • NP iron • NP aluminium oxide • NP cerium oxide • NP silicon dioxide • NP titanium dioxide • NP zinc oxide • Nanoclays • NP polystyrene • Dendrimers + Guidance manual for sponsors – including guidance on sample preparation and dosimetry

  29. Cooperation/Coordination/Harmonization • Close cooperation with OECD WPMN • International Workshop on Documentary Standards for Measurement and Characterization for Nanotechnologies – 02/08, joint workshop with IEC, OECD and NIST (see http://www.iso.org/nanotech-workshop ) • Terminology coordination through ISO/TC 229/JWG1 • Nanotechnologies Liaison Coordination Group

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