An introduction to standards and standardization for nanotechnologies

1. An introduction to standards and standardization for nanotechnologies Dr Peter Hatto, Chairman UK NTI/1, CEN TC 352 and ISO TC 229 Nanotechnologies Standardization committees Read more at BSI’s nanotechnology website for standards and news www.bsigroup.com/nano

2. 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

3. 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

4. Standards Two types of standards: Metrological standards Written 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

5. 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 …………………………………..

6. NWIP from member organisation

8. The challenges “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!!

9. 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

10. International Organisation for Standardization ISO/TC 229 - Nanotechnologies Established in June 2005 43 members – 32 “P” and 11 “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 19 other ISO TCs and 9 external bodies – IEC/TC 113, CEN/TCs 137 and 352, Asia Nano Forum, BIPM, EC JRC, IUPAC, OECD and VAMAS Exploring additional external liaisons with other groups and with emerging economies

11. International Electrotechnical Commission EC/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 29 members - 15 “P” and 14 “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

12.  Established November 2005 following a recommendation from CEN/BTWG 166 UK chair and 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. Preparing a response to a Commission mandate for the “elaboration of a programme of standards to take into account the specific properties of nanotechnology and nanomaterials”, Two working groups established in September 2008: WG 1 'Measurement, characterization and performance evaluation' WG 2 'Commercial and other stakeholder aspects'

13. 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 Work programme see: 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 Work programme see: www.cen.eu/CENORM/Sectors/TechnicalCommitteesWorkshops/CENTechnicalCommittees/WP.asp?param=508478&title=CEN%2FTC+352

14. UK Publications to date:

16. ISO/TC 229 JWG1: Strategic Roadmap 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) 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)

18. 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 AerosolsISO/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

20. 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. 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.

22. WG4 – current work programme

23. Other TC 229 structures Chairman’s Advisory Group Task Groups on: Planning and Coordination; Business Planning; Nanotechnologies and Sustainability; Societal and Consumer Dimensions of Nanotechnologies. Nanotechnologies Liaison Coordination Group (NLCG) JWG2 Study Groups on: metrology Strategy JWG2/WG3 Task Group on measurement and characterization for EHS issues relevant to nanomaterials JWG4 Task Group on nanomaterials classification

25. 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.

26. 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