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 What needs standardizing and why? Current standardization committees Existing standards, standardization projects and proposals Cooperation, coordination and harmonization

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”

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.

Standardization Standards can be: FORMAL standards are: 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.

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 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. Partial solutions Some existing standards may be applicable e.g. for chemical analysis and imaging (ISO TCs 201 and 202) and particle detection/sizing (ISO TC 24)

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

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

BSI NTI/1 Nanotechnologies Guides Guide to Safe Handling and Disposal of Free Engineered Nanoparticles Guide to Specifying Nanomaterials. 6 PAS documents Good Practice Guide for Labelling of Engineered Nanoparticles and Products Containing Engineered Nanoparticles Terminology for Medical and consumer applications of nanotechnologies Terminology for The bio-nano interface Terminology for Common Nanoscale Measurement Terms Including Instrumentation Terminology for Carbon nanostructures Terminology for Nanofabrication Terminology for Nanomaterials

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

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 – Performance Assessment 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

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

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

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 Nanotechnologies Nanostructured materials Nanomaterials Terminology - nanomaterials Nano-production Framework and core terms Project 2 Complex assemblies Terminology - nanostructures Terminology - nanofabrication Nomenclature model Nanomedical devices Nanosensors Nanomeasurement Terminology – medical and consumer Devices and applications ISO/TS: Terminology and definitions for nanoparticles – Document now approved as TS 27687 – awaiting resolution of comments ISO/TR: Terminology and nomenclature for nanotechnologies — Framework and core terms ISO/TS: Outline of Nanomaterials classification ("Nano tree") ISO/TS: Terminology and definitions for carbon nanomaterials NWIP: ISO/TS: Nanotechnologies - Core Terms - Terminology and Definitions (ballot closes 6 May 2008) Nanometrology Nanomeasurement tools Nanoelectronic devices Nanophotonic devices Terminology – nanoscale measurement (IEC) Terminology – nano-optics (IEC) Vocabulary - electrotechnical

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

Support for WG3 activities 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 ISO/TS: The Use of Transmission Electron Microscopy (TEM) in the Characterization of Single-walled Carbon Nanotubes ISO/TS: The Use of Scanning Electron Microscopy (SEM) and Energy Dispersive X-ray Analysis (EDXA) in the Characterization of Single-walled Carbon Nanotubes ISO/TS: Technical Specification for the Use of UV-Vis-NIR absorption spectroscopy in the Characterization of Single-walled Carbon Nanotubes ISO/TS: Technical Specification for the use of NIR-Photoluminescence (NIR-PL) Spectroscopy in the Characterization of Single-Walled Carbon Nanotubes ISO/TR: Use of Thermo Gravimetric Analysis (TGA) in the purity evaluation of Single Walled Carbon Nanotubes ISO/TR: Use of Evolved Gas Analysis-Gas Chromatograph Mass Spectrometry (EGA-GCMS) in the Characterization of Single-Walled Carbon Nanotubes ISO/TS: Use of Raman Spectroscopy in the Characterization of Single Walled Carbon Nanotubes. ISO/TS: Measurement Methods for the Characterization of Multi-Walled Carbon Nanotubes ISO/TS: Determination of meso-scopic shape factors of multiwalled carbon nanotubes ISO/TS: General Framework for Determining Nanoparticle Content in Nanomaterials by Generation of Aerosols Basic Metrology Length, Depth, Force, Traceability, Definition of Measurand, Uncertainty Interoperability Support for WG3 activities 16 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

Standard Methods for Toxicological ISO/TC 229 WG3 : Strategic Roadmap Standard Methods for Controlling Occupational Exposures to Nanomaterials Standard Methods for Determining Relative Toxicity/Hazard Potential of Nanomaterials Standard Methods for Toxicological Screening of Nanomaterials Future NWIP TBD Future Screening Test TBD In vivo Tox Test TBD In vitro Tox Test TBD Metrology TBD Terminology TBD Nanoparticle Inhalation Testing Workplace Monitoring Metrology TBD Terminology TBD Current Practices TR Future Occupational Standards TBD Nanoparticle Toxicity Testing Sequence Physico-Chemical characterization Endotoxin Test ISO/TR: Safe Practices in Occupational Settings Relevant to Nanotechnologies – should be balloted shortly. ISO/IS: Endotoxin test on nanomaterial samples for in vitro systems ISO/IS: Generation of nanoparticles for inhalation toxicity testing ISO/IS: Monitoring of nanoparticles in inhalation exposure chambers for inhalation toxicity testing ISO/TR Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment. Metrology TBD Terminology TBD 2008 2009 2010 2011

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

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")

TC 229 Work programme – JWG2 – SWCNT work ISO/TS: The Use of Transmission Electron Microscopy (TEM) in the Characterization of 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-walled Carbon Nanotubes (US) ISO/TS: Technical Specification for the Use of UV-Vis-NIR absorption spectroscopy in the Characterization of Single-walled Carbon Nanotubes (Japan) ISO/TS: Technical Specification for the use of NIR-Photoluminescence (NIR-PL) Spectroscopy in the Characterization of Single-Walled Carbon Nanotubes (Japan) ISO/TR: Use of Thermo Gravimetric Analysis (TGA) in the purity evaluation of Single Walled Carbon Nanotubes (US/Korea) ISO/TR: Use of Evolved Gas Analysis-Gas Chromatograph Mass Spectrometry (EGA-GCMS) in the Characterization of Single-Walled Carbon Nanotubes (Japan) ISO/TS: Use of Raman Spectroscopy in the Characterization of Single Walled Carbon Nanotubes (US)

JWG2 – MWCNT and Other Work ISO/TS: Measurement Methods for the Characterization of Multi-Walled Carbon Nanotubes (Japan) ISO/TS: Determination of meso-scopic shape factors of multiwalled carbon nanotubes (Korea) ISO/IS: General Framework for Determining 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)

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

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

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

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

Complementary structures: e. g 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

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

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

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