Standards for nanotechnologies Dr Peter Hatto, Chairman ISO TC 229, CEN TC 352 and BSI NTI/1 Nanotechnologies standardization committees Director of Research, IonBond Ltd Standards and standardization as a tool for the dissemination and implementation of research results DG Research, Brussels 14 th December 2010 Seminar on Standards and Standardization, DG Research, Brussels, 14 th December 2010 slide 1
Major challenges for nanotechnologies standardization Diversity of disciplines contributing to and impacted by nanotechnologies Global impact of nanotech developments Rapid speed of development and of commercialisation (over 1000 consumer products on the market see Woodrow Wilson International Center for Scholars inventory: http://www.nanotechproject.org/inventories/consumer/ Concern about potential negative health and environmental impacts of exposure to some nanomaterials (nanoparticles and nanofibres) Critical areas are horizontal, anticipatory standards: Guidance and protocols to ensure health and environmental safety (EHS) Terminology and nomenclature Measurement and characterization Materials specifications Coordination and harmonization across standards developers and stakeholders Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 2
International standards bodies for nano ISO TC 229 Nanotechnologies Established June 2005 Currently 36 P members and 8 O members (see http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical _committee_participation.htm?commid=381983 ) Liaisons with 26 other ISO/IEC/CEN TCs and SCs and 9 external bodies ANF, BIPM, EC JRC, ECOS, IRMM, IUPAC, OECD, VAMAS and ETUI CEN TC 352 Nanotechnologies Established November 2005 All 30 members of CEN are notionally members around 12 active (see http://www.cen.eu/cen/sectors/technicalcommitteesworkshops/centechnicalcommittees/pages/ default.aspx?param=508478&title=cen/tc%20352 ) Liaisons with 10 CEN/ISO TCs and 9 external bodies ECOS, ENTA, NORMAPNE, NIA, EC DGs Enterprise and Industry, Environment, Health and Consumer Protection, JRC & Research Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 3
TC 229 - Nanotechnologies Structure/working areas Material Specifications (WG4) (Convened by China) 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 Support for REGULATION and voluntary governance structures Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 4
ISO/TC 229 STRUCTURE TC 229 NLCG NLCG CAG CAG Planning & coordination TG Nanotechnology & Nanotechnology & sustainability TG sustainability TG Societal & Societal & Consumer issues Consumer issues TG TG JWG 1 Terminology & Nomenclature JWG 2 Measurement & Characterization WG 3 Health, safety & environment WG 4 Material specifications Nomenclature model TG Strategy Study Group Metrology Study Group Harmonization of terms TG Strategy & Roadmap SG Material Specifications SG Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 5
ISO/TC 229 JWG1: Published/approved documents and current work Vocabulary - Part 5: Nano-bio interface Nanoproduction Nanoprocesses Vocabulary - Part 8: nanomanufacturing processes Nanotechnologies Nanomeasurement Vocabulary - Part 6: nanoscale measurement and instrumentation Nano-object terms Vocabulary Base Core Terms Nano-object framework for core Documents concepts nanoscale Nanoparticle nanotechnology Nanofibre nanoscience Nanoplate nanomaterial Nanotube nano-object Nanorod nanostructure Nanowire nanostructured material Particle manufactured nanomaterial Ultrafine particle engineered nanomaterial incidental Quantum nanomaterial dot nanomanufacturing Agglomerate nanomanufacturing Aggregate process nanoscale Equivalent phenomenon diameter nanoscale Specific property surface area mean diameter Nomenclature model Nanomaterials Vocabulary Part 2: nano-objects nanoparticle, nanofibre and nanoplate published as TS 27687, August 2008 Vocabulary Part 3: carbon nano-objects published as TS 80004-3 May 2010 Vocabulary - Part 4: nanostructured materials Nanomaterials classification Devices and applications Vocabulary - Part 1: Core Terms Vocabulary - Part 7: Healthcare Therapeutics and Diagnostics Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 6
Accessing ISO agreed definitions the ISO Concept Database http://cdb.iso.org, login as Guest Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 7
ISO/TC 229 JWG2: Published/Approved documents and current work Electrical characterization of Carbon Nanotubes Using 4- Probe Measurement (TS) Measurement Methods for Characterizing Multi-Walled Carbon Nanotubes (TR) Determination of shape factors of multiwalled carbon nanotubes (TS) Determination of Metal Impurities in Carbon Nanotubes Using Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) - TS SWCNT characterization MWCNT characterization IS: General Framework for Determining Nanoparticle Content in Nanomaterials by Generation of Aerosol TS: Artificial gratings used in nanotechnology: description and measurement of dimensional quality parameters TS: Generic requirements for reference materials for development of methods for characteristic testing, performance testing and safety testing of nano-particle and nano-fiber powders Joint developments with CEN (CEN lead): TR: Guide to methods for nano-tribology measurements Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 8
ISO/TC 229 WG3: Published/Approved documents and current work Controlling Occupational Exposures to Nanomaterials ISO/TR 12885 - Safe Practices in Occupational Settings Relevant to Nanotechnologies - published autumn 2008 TR: Nanomaterial risk evaluation framework TS: Guidance on safe handling and disposal of manufactured nanomaterials TS: Guidelines for occupational risk management of nanomaterials based on "control banding TR: Preparation of Material Safety Data Sheet (MSDS) for nanomaterials Toxicological Screening of Nanomaterials - cooperation with OECD WPMN TS: Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening - FT-IR method TR: Guidance on toxicological screening methods for manufactured nanomaterials TR: Guidance on sample preparation methods and dosimetry considerations for manufactured nanomaterials (for toxicology screening) TS: Determination of Muramic Acid as a biomarker for silver nanoparticles activity Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 9
TC 229 Work programme Materials specifications (WG4) TS: Materials specification for nano-titanium dioxide Part 1 General requirements TS: Materials specification for nano-titanium dioxide Part 2 Requirements for specific applications TS: Materials specification for nano-calcium carbonate Part 1 General requirements TS: Materials specification for nano-calcium carbonate Part 2 Requirements for specific applications TS: Guidance on specifying manufactured nano-materials Other Projects Joint development with CEN (CEN lead): Guidance on labelling of products containing manufactured nanoparticles under preparation for ballot in both committees Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 10
MATERIALS ISO/TC 91 Surface active agents Coordination and harmonization considerations ISO/TC 107 Metallic and other inorganic coatings ISO/TC 119 Powder metallurgy ISO/TC 122 Packaging ISO/TC 206 Fine ceramics ISO/TC 217 Cosmetics ISO/TC 84 Devices for administration of medical products and intravascular catheters ISO/TC150 Implants for surgery BIOMEDICAL ISO/TC 61 Plastics ISO/TC 168 Prosthetics and orthotics ISO/TC 59 Building construction EXTERNAL LIAISONS RISK/HS&E ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems ISO/TC 38 Textiles ISO/TC 35 Paints and varnishes ISO/TC 34 Food products ISO/TC 48 Laboratory equipment NANO- PARTICLES ISO/TC 172 Optics and photonics ISO/TC 184 Industrial automation systems and integration Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 11 METROLOGY AND CHARACTERIZATION ISO/TC 203 Technical energy systems ISO/TC 180 Solar energy ISO/TC 215 Environmental management ISO/TC 28 Petroleum and petroleum products ENERGY ISO/TC 225 Market opinion and social research ISO/TC 215 Health Informatics
CEN/TC 352 Work mostly done in collaboration with ISO/TC 229 using the Vienna Agreement, with ISO lead Responsible for coordinating development of standards to satisfy EC MANDATE ADDRESSED TO CEN, CENELEC AND ETSI FOR STANDARDIZATION ACTIVITIES REGARDING NANOTECHNOLOGIES AND NANOMATERIALS (M/461) : Validated methods for determination of physicochemical properties relevant to hazard characterisation of nanomaterials Sampling and measurement of workplace, consumer and environment exposure Methods to simulate exposures to nanomaterials H, S & E Further work on terminology and nomenclature many items within the scope of other CEN or ISO technical committees hence need for coordination Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 12
What standards are still needed for commerce and regulation Support for the commercial perspective if you can t measure it you can t make it Validated characterization techniques for manufactured nano-objects: Basic character set - composition, geometrical properties, sampling methods Advanced character set e.g. elemental structure, chemical functionality, electrical, magnetic, mechanical, optical properties Validated characterization techniques for coatings and nanostructured materials Basic character set: geometrical properties, composition, density Advanced character set e.g. electrical, magnetic, mechanical, optical, thermal.. properties Materials specifications generic and specific H, S and E, including life cycle evaluation and end of life treatment Terminology and nomenclature relevant to specific nanomaterial classes Application standards will be done by sector committees Support for the regulatory perspective: if you can t define it and you can t measure it then you can t regulate it - European Commission Mandate M/469 and OECD WPMN Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 13
Issues for standardization Effective participation of all parties concerned, i.e. all stakeholders at the national level issue of pay to play in some countries Identification and active participation of experts Training of experts and project leaders Informed and complete response to ballots by national member bodies Vigilance of all national members Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 14
Thank you Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 15