An introduction to standards and standardization for nanotechnologies Dr Peter Hatto, Chairman UK NTI/1 and ISO TC 229 Nanotechnologies Standardization committees Read more at BSI’s nanotechnology website for standards and news www.bsigroup.com/nano

Overview Why standards for nanotechnologies are important Standards and standardization Role of standards Standardization organisations Development of formal standards Standardization for nanotechnologies Why are nanotechnologies important Major challenges for standardization Current International and European standardization committees Existing standards and standardization projects Cooperation, coordination and harmonization

Why standards for nanotechnologies are important Standards will help to ensure the open, safe and responsible development of nanotechnologies 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 By providing agreed ways of: Naming, describing and specifying things Measuring and testing things Protocols for health and environmental safety testing, risk assessment and risk management

Standards Two types of standards: Metrological standards Written (‘documentary’) standards Written Standards provide agreed ways of: Naming, describing and specifying things Measuring and testing things Managing things e.g. quality and environmental emissions: ISO 9001 and ISO 14000 Reporting things as in e.g. proposed ISO 26000 (Social Responsibility) To: Support innovation, commercialisation, market development and established markets Provide a basis for procurement 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 incorporated into a contract or regulation. Standards are based on CONSENSUS not necessarily unanimity

Standards – “not essential to life but absolutely essential to modern living” Standards are: Ubiquitous – covering such things as shoe sizes, nuts and bolts, petrol grades, warning signs, pipes and fittings, fire extinguishers, gas cylinders, shipping containers, electrical sockets and plugs, steel specifications,………….. Virtually invisible to “the man in the street” – there are over 16,500 International Standards, many with multiple parts; Absolutely critical to our modern way of life – covering things such as: internet protocols, aircraft fuels credit cards, business continuity management quality and environmental management, carbon trading, sustainable development life cycle costing …………………………………..

NWIP from member organisation Development of International Standards Process accommodates special needs NWIP from member organisation Approval – at least 5 P members agree to participate and >50% of members voting are in favour First level of consensus (amongst experts) { Second level of consensus (amongst members of ISO) Also ISO/TR for informative documents

Why is nanotechnology important? US Interagency Working Group on Nano Science, Engineering and Technology (IWGN) workshop on Nanotechnology Research Directions (Sept. ’99): “nanotechnology will be a strategic branch of science and engineering for the 21st century, one that will fundamentally restructure the technologies currently used for manufacturing, medicine, defence, energy production, environmental management, transportation, communication, computation and education.” US NSF report on “SOCIETAL IMPLICATIONS OF NANOSCIENCE AND NANOTECHNOLOGY” March 2001: “the impact of nanotechnology in the 21st century is likely to be at least as significant for health, wealth and security as the combined influences of antibiotics, integrated circuits and polymers.” Projected world-wide market for n-t enabled products will be >$500 Billion but <$3 trillion by 2015 “It is estimated that Nanotechnology is presently at a level of development similar to that of computer/information technology in the 1950s” (Nanostructure Science and Technology: A Worldwide Study, WTEC Panel report, 1999)

The challenges The Interagency Working Group on Nanotechnology workshop in 1999 concluded: “while recognizing nanotechnology’s potential to spawn an industrial revolution in coming decades, the consensus was that the challenges ahead in basic discovery, invention and eventual manufacturing are formidable. New methods of investigation at the nanoscale, novel scientific theories, and different fabrication paradigms are critical.” “Nanotechnolgy will only become a coherent field of endeavour through the confluence of three important technological streams: New and improved control of the size and manipulation of nanoscale building blocks; New and improved characterization (spatial resolution, chemical sensitivity, etc) of materials at the nanoscale; New and improved understanding of the relationship between nanostructure and properties and how these can be engineered” And don’t forget safety and consumer acceptance!!

Major challenges for standardization for nanotechnologies Diversity of disciplines impacted by and contributing to nanotechnologies Global impact Rapid speed of development and apparent speed of commercialisation (over 800 consumer products on the market – see Woodrow Wilson International Center for Scholars inventory: www.nanotechproject.org/inventories/consumer ) Critical areas: Coordination and harmonization across standards developers and stakeholders Terminology Measurement and characterization Health, safety and environmental issues Material specifications

International Organisation for Standardization ISO/TC 229 - Nanotechnologies Established in June 2005 44 members – 36 “P” and 8 “O” (see www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=381983 ) Works closely with IEC/TC 113 and CEN/TC 352 Liaisons with 26 ISO/IEC/CEN TCs and 9 external bodies –Asia Nano Forum, BIPM, EC JRC, ECOS, ETUI, IRMM, IUPAC, OECD and VAMAS Exploring additional external liaisons with other groups and with emerging economies

Established June 2006 with US Chair and German secretariat International Electrotechnical Commission IEC/TC 113 – “Nanotechnology standardization for electrical and electronic products and systems” Established June 2006 with US Chair and German secretariat www.iec.ch/cgi-bin/procgi.pl/www/iecwww.p?wwwlang=e&wwwprog=dirdet.p&progdb=db1&css_color=purple&committee=TC&number=113 32 members - 18 “P” and 14 “O” Agreed to establish two Joint Working Groups with ISO/TC 229: JWG 1 – Terminology and nomenclature JWG 2 – Measurement and characterization Together with a third Working Group: WG 3 – Performance assessment

Established November 2005 following a recommendation from CEN/BTWG 166 European Committee for Standardization CEN/TC 352 - Nanotechnologies Established November 2005 following a recommendation from CEN/BTWG 166 French chair and joint French/Czech Republic secretariat All 30 members of CEN are notionally members – around 14 active Works closely with ISO/TC 229 using the ‘Vienna Agreement’ for cooperative working. Developing a work programme to include areas of specific interest to Europe and areas that will be relevant to European legislation. Coordinating work programme to address European Commission mandate M/461 for standardization activities regarding nanotechnologies and nanomaterials. Two working groups established in September 2008: WG 1 'Measurement, characterization and performance evaluation' WG 2 'Commercial and other stakeholder aspects'

Published standards and work programmes – ISO, IEC and CEN ISO/TC 229, Published standards see: www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=381983&published=on&includesc=true Work programme see: www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=381983&development=on IEC/TC 113, Published standards see: www.iec.ch/cgi-bin/procgi.pl/www/iecwww.p?wwwlang=e&wwwprog=TCpubs.p&progdb=db1&committee=TC&css_color=purple&number=113 www.iec.ch/cgi-bin/procgi.pl/www/iecwww.p?wwwlang=e&wwwprog=sea1122.p&progdb=db1&css_color=purple&class=&refno=&committee=&pubno=&header=*+(all)&search=program&pcomm=113 CEN/TC 352, Published standards see: www.cen.eu/CENORM/Sectors/TechnicalCommitteesWorkshops/CENTechnicalCommittees/Standards.asp?param=508478&title=CEN%2FTC+352 www.cen.eu/CENORM/Sectors/TechnicalCommitteesWorkshops/CENTechnicalCommittees/WP.asp?param=508478&title=CEN%2FTC+352

UK Publications and work programme Publicly Available Specifications (PAS): PAS 71 Vocabulary – Nanoparticles (under revision) PAS 131 Terminology for medical, health and personal care applications of nanotechnologies PAS 132 Terminology for the bio-nano interface PAS 133 Terminology for nanoscale measurement and instrumentation PAS 134 Terminology for carbon nanostructures PAS 135 Terminology for nanofabrication PAS 136 Terminology for nanostructured materials PAS 130 Guidance on the labelling of manufactured nanoparticles and products containing manufactured nanoparticles Published Documents (PD) PD 6699-1 Guide to specifying nanomaterials PD 6699-2 Guide to safe handling and disposal of manufactured nanomaterials PD 6699-3 Guide to assessing airborne exposure in occupational settings relevant to nanomaterials All documents are available for free download at www.bsigroup.com/nano except PD 6699-3 Under development: PAS 137 - Nanomaterials and nanotechnology-based products – Guidance on legislation and standards for SMEs

ISO TC 229 – Horizontal activities 1 Terminology and Nomenclature (JWG 1) “what you call it” - Convened by Canada

ISO/TC 229 JWG1: Strategic Roadmap Framework and core terms Base Definitions Nano films Nano dispersions Terminology –carbon nanostructures Nomenclature model Nano-processes Terminology - nanoparticles Nanomaterials classification Terminology – nano-bio interface Nanoscale objects Nanostructured materials Nanotechnologies Nanomaterials Terminology - nanomaterials Nano-production Complex assemblies Terminology - nanostructures Terminology - manufacturing 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

ISO TC 229 – Horizontal activities 2 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 18 18

ISO TC 229 – Horizontal activities 3 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

ISO/TC 229 WG3 : Strategic Roadmap Toxicological Screening of Nanomaterials - cooperation with OECD WPMN Controlling Occupational Exposures to Nanomaterials Determining Relative Hazard Potential of Nanomaterials Future NWIP TBD Future Screening Test TBD MSDS guidance Future NWIP TBD Risk management ‘control banding’ Sequence Nanoparticle Inhalation Testing Risk evaluation framework Support to In vivo Tox Test TBD Physico-Chemical characterization Safe handling guidance Support to In vitro Tox Test TBD Current Practices Endotoxin Test Metrology TBD 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. Workplace Monitoring Metrology TBD Metrology TBD Terminology TBD Terminology TBD Terminology TBD 2007……..8……….9………10... 2007……..8……….9………10. 2010……..11…….12…..

ISO 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

WG4 – current work programme

Other TC 229 structures Chairman’s Advisory Group Task Groups on: Planning and Coordination; Nanotechnologies and Sustainability; Societal and Consumer Dimensions of Nanotechnologies. Nanotechnologies Liaison Coordination Group (NLCG) JWG2 Study Groups on: Metrology Strategy

Current and potential liaisons for ISO/TC 229 Metallic and other inorganic coatings ISO/TC 38 Textiles ISO/TC 206 Fine ceramics ISO/TC 122 Packaging ISO/TC 119 Powder metallurgy ISO/TC 91 Surface active agents ISO/TC 84 Devices for administration of medical products and intravascular catheters MATERIALS BIOMEDICAL ISO/TC 61 Plastics Current and potential liaisons for ISO/TC 229 ENERGY ISO/TC 168 Prosthetics and orthotics ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems ISO/TC 215 Health Informatics ISO/TC 225 Market opinion and social research Environmental management ISO/TC 28 Petroleum and petroleum products ISO/TC 180 Solar energy ISO/TC 203 Technical energy systems ISO/TC 184 Industrial automation systems and integration ISO/TC 172 Optics and photonics ISO/TC150 Implants for surgery ISO/TC 217 Cosmetics ISO/TC 34 Food products ISO/TC 48 Laboratory equipment NANO-PARTICLES METROLOGY AND CHARACTERIZATION EXTERNAL LIAISONS RISK/HS&E BIPM ISO/TC 142 Cleaning equipment for air and other gases ISO/TC 59 Building construction ISO/TC 35 Paints and varnishes ISO/TC 45 Rubber and rubber products

The roles of ISO/TC 229, IEC/TC 113 and CEN/ TC 352 will be to identify requirements in cooperation with stakeholders, including industry, governments, regulators, OECD, the European Commission, and the public, to coordinate standards development with relevant TCs, and to develop standards where no TC exists or where the existing TC does not have the necessary resources.

Why standards for nanotechnologies are important Standards will help to ensure the open, safe and responsible development of nanotechnologies 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 By providing agreed ways of: Naming, describing and specifying things Measuring and testing things Protocols for health and environmental safety testing, risk assessment and risk management Read more at BSI’s nanotechnology website for standards and news www.bsigroup.com/nano