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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

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

3.
Why standards for nanotechnologies are important <ul><li>Standards will help to ensure the open, safe and responsible development of nanotechnologies by supporting: </li></ul><ul><ul><ul><li>safety testing, legislation and regulation </li></ul></ul></ul><ul><ul><ul><li>worker, public and environmental safety </li></ul></ul></ul><ul><ul><ul><li>commercialisation and procurement </li></ul></ul></ul><ul><ul><ul><li>patenting and IPR </li></ul></ul></ul><ul><ul><ul><li>communication about the benefits, opportunities and potential problems associated with nanotechnologies </li></ul></ul></ul><ul><li>By providing agreed ways of: </li></ul><ul><ul><ul><li>Naming, describing and specifying things </li></ul></ul></ul><ul><ul><ul><li>Measuring and testing things </li></ul></ul></ul><ul><ul><ul><li>Protocols for health and environmental safety testing, risk assessment and risk management </li></ul></ul></ul>

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Standards <ul><li>Two types of standards: </li></ul><ul><ul><li>Metrological standards </li></ul></ul><ul><ul><li>Written (‘documentary’) standards </li></ul></ul><ul><li>Written Standards provide agreed ways of: </li></ul><ul><ul><ul><li>Naming, describing and specifying things </li></ul></ul></ul><ul><ul><ul><li>Measuring and testing things </li></ul></ul></ul><ul><ul><ul><li>Managing things e.g. quality and environmental emissions: ISO 9001 and ISO 14000 </li></ul></ul></ul><ul><ul><ul><li>Reporting things as in e.g. proposed ISO 26000 (Social Responsibility) </li></ul></ul></ul><ul><li>To: </li></ul><ul><ul><ul><li>Support innovation, commercialisation, market development and established markets </li></ul></ul></ul><ul><ul><ul><li>Provide a basis for procurement </li></ul></ul></ul><ul><ul><ul><li>Support appropriate legislation/regulation </li></ul></ul></ul><ul><li>Can be NORMATIVE , defining what MUST be done in e.g. a specific test </li></ul><ul><li>method, or INFORMATIVE , providing information only. </li></ul><ul><li>Standards are VOLUNTARY unless incorporated into a contract or </li></ul><ul><li>regulation. </li></ul><ul><li>Standards are based on CONSENSUS not necessarily unanimity </li></ul>

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Standards – “not essential to life but absolutely essential to modern living” <ul><li>Standards are: </li></ul><ul><ul><ul><li>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,………….. </li></ul></ul></ul><ul><ul><ul><li>Virtually invisible to “the man in the street” – there are over 16,500 International Standards, many with multiple parts; </li></ul></ul></ul><ul><ul><ul><li>Absolutely critical to our modern way of life – covering things such as: </li></ul></ul></ul><ul><ul><ul><ul><ul><li>internet protocols, </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>aircraft fuels </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>credit cards, </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>business continuity management </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>quality and environmental management, </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>carbon trading, </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>sustainable development </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>life cycle costing </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>………………………………… .. </li></ul></ul></ul></ul></ul>

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NWIP from member organisation Development of International Standards Process accommodates special needs Also ISO/TR for informative documents 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)

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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 .” “ 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) 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

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The challenges <ul><li>“ Nanotechnolgy will only become a coherent field of endeavour through the confluence of three important technological streams: </li></ul><ul><ul><li>New and improved control of the size and manipulation of nanoscale building blocks; </li></ul></ul><ul><ul><li>New and improved characterization (spatial resolution, chemical sensitivity, etc) of materials at the nanoscale; </li></ul></ul><ul><ul><li>New and improved understanding of the relationship between nanostructure and properties and how these can be engineered” </li></ul></ul><ul><ul><li>And don’t forget safety and consumer acceptance!! </li></ul></ul>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.”

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Major challenges for standardization for nanotechnologies <ul><ul><ul><li>Diversity of disciplines impacted by and contributing to nanotechnologies </li></ul></ul></ul><ul><ul><ul><li>Global impact </li></ul></ul></ul><ul><ul><ul><li>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 ) </li></ul></ul></ul><ul><ul><ul><li>Critical areas: </li></ul></ul></ul><ul><ul><ul><ul><li>Coordination and harmonization across standards developers and stakeholders </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Terminology </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Measurement and characterization </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Health, safety and environmental issues </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Material specifications </li></ul></ul></ul></ul>

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International Organisation for Standardization ISO/TC 229 - Nanotechnologies <ul><ul><li>Established in June 2005 </li></ul></ul><ul><ul><li>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 ) </li></ul></ul><ul><ul><li>Works closely with IEC/TC 113 and CEN/TC 352 </li></ul></ul><ul><ul><li>Liaisons with 26 ISO/IEC/CEN TCs and 9 external bodies –Asia Nano Forum, BIPM, EC JRC, ECOS, ETUI, IRMM, IUPAC, OECD and VAMAS </li></ul></ul><ul><ul><li>Exploring additional external liaisons with other groups and with emerging economies </li></ul></ul>

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

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

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

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

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

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ISO/TC 229 JWG1: Strategic Roadmap Nanosensors Nanoelectronic devices Devices and applications Nanophotonic devices Terminology – medical and consumer (IEC) Terminology – nano-optics (IEC) Vocabulary - electrotechnical Nanomedical devices Nanotechnologies Nanomeasurement Nano-production Nano-processes Base Definitions Framework and core terms Terminology - manufacturing Terminology – nanoscale measurement Terminology – nano-bio interface Nomenclature model Nanometrology Nanomeasurement tools Nano films Nanostructured materials Complex assemblies Nanoscale objects Nanomaterials Terminology - nanoparticles Terminology - nanostructures Terminology –carbon nanostructures Terminology - nanomaterials Nano dispersions Nanomaterials classification

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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

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

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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

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

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ISO 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 Material Specifications (WG4) (Convened by China) PRODUCT AND PROCESS (sc) PRODUCT AND PROCESS (sc) Support for “REGULATION” and voluntary governance structures

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WG4 – current work programme

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

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ISO/TC 107 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 ISO/TC 215 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

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<ul><li>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. </li></ul>

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Why standards for nanotechnologies are important <ul><li>Standards will help to ensure the open, safe and responsible development of nanotechnologies by supporting: </li></ul><ul><ul><ul><li>safety testing, legislation and regulation </li></ul></ul></ul><ul><ul><ul><li>worker, public and environmental safety </li></ul></ul></ul><ul><ul><ul><li>commercialisation and procurement </li></ul></ul></ul><ul><ul><ul><li>patenting and IPR </li></ul></ul></ul><ul><ul><ul><li>communication about the benefits, opportunities and potential problems associated with nanotechnologies </li></ul></ul></ul><ul><li>By providing agreed ways of: </li></ul><ul><ul><ul><li>Naming, describing and specifying things </li></ul></ul></ul><ul><ul><ul><li>Measuring and testing things </li></ul></ul></ul><ul><ul><ul><li>Protocols for health and environmental safety testing, risk assessment and risk management </li></ul></ul></ul><ul><li>Read more at BSI’s nanotechnology website for standards and news www.bsigroup.com/nano </li></ul>