Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 1
Standards for nanotechnologiesDr Peter Hatto,Chairman ISO TC 229, CEN TC 352 and BSI NTI/1 Nanotechnologies standardization committeesDirector of Research, IonBond LtdStandards and standardization as a tool for the dissemination and implementation of research resultsDG Research, Brussels14th December 2010
Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 2
Major challenges for nanotechnologies standardizationDiversity of disciplines contributing to and impacted by nanotechnologiesGlobal impact of nanotech developmentsRapid 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 nomenclatureMeasurement and characterizationMaterials specificationsCoordination and harmonization across standards developers and stakeholders
Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 3
‘International’ standards bodies for nano
ISO TC 229 NanotechnologiesEstablished June 2005Currently 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 NanotechnologiesEstablished November 2005All 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 4
TC 229 - Nanotechnologies – 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 (W
G4)
(Convened by C
hina)
Support for “REG
ULA
TION
”and
voluntary governance structures
Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 5
ISO/TC 229 STRUCTURETC 229TC 229
JWG 1Terminology & Nomenclature
JWG 2Measurement &Characterization
WG 3Health, safety &
environment
WG 4Material
specifications
NLCGNLCG CAGCAG
Nanotechnology & sustainability TGNanotechnology &
sustainability TG
Planning & coordination TG
Nomenclature modelTG
Strategy Study Group
MetrologyStudy Group
Harmonization of termsTG
Strategy & RoadmapSG
Societal &Consumer issues
TGSocietal &
Consumer issuesTG
Material SpecificationsSG
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ISO/TC 229 JWG1: Published/approved documents and current work
Devices and applications
Vocabulary - Part 7: Healthcare –Therapeutics and Diagnostics
Nanomeasurement
Nano-production
Nano-processes
Vocabulary - Part 8: nanomanufacturing
processes
Vocabulary - Part 6: nanoscale measurement
and instrumentation
Vocabulary - Part 5: Nano-bio interface
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: nanostructuredmaterials
Nanomaterials classification
BaseDocuments
Vocabulary –framework for core
concepts
Nomenclature model
Nanotechnologies
Vocabulary - Part 1: Core TermsCore Terms
nanoscalenanotechnologynanosciencenanomaterialnano-objectnanostructurenanostructured materialmanufactured nanomaterialengineered nanomaterialincidental nanomaterialnanomanufacturingnanomanufacturing processnanoscale phenomenonnanoscale property
Nano-ob ject terms • Nano-ob ject • Nanoparticle • Nanofib re • Nanoplate • Nanotube • Nanorod • Nanow ire • Particle • Ultra fine partic le • Quantum dot • Agglom erate • Aggregate • Equivalent d iam eter • Specific surface area m ean diameter
Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 7
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 8
ISO/TC 229 JWG2: Published/Approved documents and current work
Determination of shape factors of
multiwalled carbon nanotubes (TS)
Measurement Methods for
CharacterizingMulti-Walled
Carbon Nanotubes(TR)
Electrical characterization of Carbon Nanotubes Using 4-
Probe Measurement (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 AerosolTS: 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 9
ISO/TC 229 WG3: Published/Approved documents and current work
TS: Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening - FT-IR methodTR: Guidance on toxicological screening methods for manufactured nanomaterialsTR: 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
Toxicological Screening of Nanomaterials- cooperation with OECD WPMN
Toxicological Screening of Nanomaterials- cooperation with OECD WPMN
ISO/TR 12885 - Safe Practices in Occupational Settings Relevant to Nanotechnologies - published autumn 2008TR: Nanomaterial risk evaluation framework TS: Guidance on safe handling and disposal of manufactured nanomaterialsTS: Guidelines for occupational risk management of nanomaterials based on "control banding“TR: Preparation of Material Safety Data Sheet (MSDS) for nanomaterials
Controlling Occupational Exposures to NanomaterialsControlling Occupational Exposures to Nanomaterials
Seminar on Standards and Standardization, DG Research, Brussels, 14th December 2010 slide 10
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 ProjectsJoint 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 11
ISO/TC 107Metallic and
other inorganic coatings
ISO/TC 38
Textiles
ISO/TC 59
Building construction
ISO/TC 206
Fine ceramics
ISO/TC 122
PackagingISO/TC 119
Powder metallurgy
ISO/TC 91
Surface active agents
ISO/TC 84Devices for
administration of medical products and intravascular
catheters
MATERIALS BIOMEDICAL
Coordination and harmonization considerations
ISO/TC 61
Plastics
ENERGY
ISO/TC 168Prosthetics
and orthotics
ISO/TC 212Clinical
laboratory testing and in
vitro diagnostic test systems
ISO/TC 215Health
Informatics
ISO/TC 225Market
opinion and social
research
ISO/TC 215Environmental management
ISO/TC 28Petroleum and
petroleum productsISO/TC 180
Solar energyISO/TC 203
Technical energy
systems
ISO/TC 184Industrial
automation systems and integration
ISO/TC 172
Optics and photonics
ISO/TC150Implants for
surgery
ISO/TC 34Food
products
ISO/TC 217Cosmetics
ISO/TC 48Laboratory equipment
ISO/TC 35Paints and varnishes
NANO-PARTICLES METROLOGY AND
CHARACTERIZATION
EXTERNAL LIAISONS RISK/HS&E
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CEN/TC 352
Work mostly done in collaboration with ISO/TC 229 using the ‘Vienna Agreement’, with ISO leadResponsible 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 nanomaterialsSampling and measurement of workplace, consumer and environment exposure Methods to simulate exposures to nanomaterialsH, S & EFurther work on terminology and nomenclature
– many items within the scope of other CEN or ISO technical committees hence need for coordination
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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 methodsAdvanced character set – e.g. elemental structure, chemical functionality, electrical, magnetic, mechanical, optical properties
Validated characterization techniques for coatings and nanostructured materialsBasic character set: geometrical properties, composition, densityAdvanced character set – e.g. electrical, magnetic, mechanical , optical, thermal ….. properties
Materials specifications – generic and specificH, S and E, including life cycle evaluation and end of life treatmentTerminology and nomenclature relevant to specific nanomaterial classesApplication 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 14
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
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