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Dr Peter Hatto,
Chairman UK NTI/1 and ISO TC 229 Nanotechnologies Standardization committees
Version 6, May 2007
y y y y y y y y Why standards for nanotechnologies are important Standards and standardization Why is nanotechnology important? What needs standardizing and why? Current standardization committees Existing standards, standardization projects and proposals; Pre- and co-normative research to support future needs; Support for possible regulation
Version 6, May 2007
Why standards for nanotechnologies are important Standards will help to ensure that nanotechnology is developed and commercialised in an open, safe and responsible manner by supporting: y safety testing, legislation and regulation y worker, public and environmental safety y commercialisation and procurement y patenting and IPR y communication about the benefits, opportunities and potential problems associated with nanotechnologies This will be achieved by providing agreed ways of: y Naming, describing and specifying things y Measuring and testing things y Health and environmental safety testing, risk assessment and risk management
Version 6, May 2007
quantity of matter ± primary and secondary standards y Written standards Written Standards provide agreed ways of: y y y y To: y y y Naming. mass. a specific test method. May 2007 . proposed ISO 26000 (Social Responsibility) support commercialisation and market development provide a basis for procurement based on technical requirements and quality/environmental management support appropriate legislation/regulation Can be NORMATIVE. quality and environmental management: ISO 9001 and ISO 14000 Reporting things as in e. Standards provide a means of ³validated quantification´ Version 6.g. or INFORMATIVE. describing and specifying things Measuring and testing things Managing things e.g. defining what MUST be done in e.Standards Standards can be of two types: y Metrological standards: length. providing information only. Standards are VOLUNTARY unless called in a contract or regulation.g. time.
gas cylinders. nuts and bolts. May 2007 . steel specifications. y But are absolutely critical to our modern way of life ± covering things such as CDs/DVDs. pin numbers. internet protocols. electrical sockets and plugs. petrol grades. Version 6.000 International Standards. many with multiple parts.. warning signs. quality and environmental management.«««««««««««. y Virtually invisible to ³the man in the street´ ± there are over 15.««««. fire extinguishers. pipes and fittings.Standards Standards are: y Ubiquitous ± covering such things as shoe sizes. credit cards.
and standardization Standards can be: y FORMAL ± developed by independent experts working under the auspices of a National. SEMI. y ISO. May 2007 . Version 6. ««««««« y CEN. JIS.e. IEC & ITU y INFORMAL ± developed by a SDO (Standards Development Organisation) y ASTM. DEVELOPED AND APPROVED by the members of the standards body y Based on CONSENSUS (i. VDI«(>600 SDOs IN US) y PRIVATE ± developed by a company or trade association FORMAL standards are: y PROPOSED. Regional or International standards body y AFNOR. ETSI«. CENELEC. BSI. IEEE. no sustained opposition) not necessarily unanimity. SAE. DIN..
g.g. shoe sizes. electrical plugs and outlets. V. Version 6. suit sizes ± leading to mass production and price reduction y Information/Measurement y Test and measurement methods for describing. May 2007 .Functions of standards Standards can perform any of the following four functions: y Interoperability/Compatibility y as with e. railway gauges. nuts and bolts. and interoperability standards for computers and telecommunications systems y Quality y Fitness for purpose or safety y Variety reduction/optimization (based on best practice) y E. quantifying and evaluating product attributes such as material. processes and functions DIN has reported that in Europe standardization adds approximately 1% to the value of gross domestic product and that the added value generated by standardisation is at least as important as the value generated by patents! ± see ³Economic benefits of standardization´ Published by DIN German Institute for Standardization e.
Extent of ISO System 151 full-time posts fullSecretary 734 Secretariats held by by 37 countries Ch C E E E WG E E Chairman More than 14 941 ISO Standards About 190 TCs Convenor C Standardization projects 544 SCs Standardization projects 2 188 WGs 4 176 active projects (30 June 2005) version 3. Jan 10 2007 .
Jan 10 2007 Approval ± at least 5 P members agree to participate and >50% of members in favour Published as ISO/PAS Published as ISO/TS Also ISO/TR for informative documents .Development of International Standards Process accommodates special needs NWIP from member organisation External process ISO TC/SC process NP WD Final WD Text First CD Final CD Text DIS FDIS International Standard ISO Workshop IWA version 3.
transportation. integrated circuits and polymers. medicine.Why is nanotechnology important? US Interagency Working Group on Nano Science. one that will fundamentally restructure the technologies currently used for manufacturing. ¶99): ³nanotechnology will be a strategic branch of science and engineering for the 21st century. WTEC Panel report.´ US NSF report on ³SOCIETAL IMPLICATIONS OF NANOSCIENCE AND NANOTECHNOLOGY´ March 2001: ³the impact of nanotechnology in the 21st century is likely to be at least as significant for health. defence. energy production. May 2007 .´ Projected world-wide market for n-t enabled products will be >$500 Billion but <$3 trillion by 2015 ³It 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. environmental management. 1999) Version 6. wealth and security as the combined influences of antibiotics. computation and education. communication. Engineering and Technology (IWGN) workshop on Nanotechnology Research Directions (Sept.
´ ³Nanotechnolgy will only become a coherent field of endeavour through the confluence of three important technological streams: y New and improved control of the size and manipulation of nanoscale building blocks. May 2007 . the consensus was that the challenges ahead in basic discovery. and different fabrication paradigms are critical. etc) of materials at the nanoscale. y New and improved characterization (spatial resolution. novel scientific theories.The challenges The Interagency Working Group on Nanotechnology workshop in 1999 concluded: ³while recognizing nanotechnology¶s potential to spawn an industrial revolution in coming decades. y New and improved understanding of the relationship between nanostructure and properties and how these can be engineered´ y And don¶t forget safety and consumer acceptance!! Version 6. invention and eventual manufacturing are formidable. New methods of investigation at the nanoscale. chemical sensitivity.
or where the existing TC does not have the necessary resources. y New calibration procedures and certified references materials are needed for validation of test instruments at the nanoscale. 3. for chemical analysis and imaging (ISO TCs 201 and 202) and particle detection/sizing (ISO TC 24) y Hence there is a need for a dedicated committee to coordinate standards development with relevant TCs. Partial solutions y But some existing standards may be applicable e. y No standardized protocols for evaluating environmental impact of nanoparticles.g.Needs for standardization 1. 2. y Existing ³methods of test´ may not be suitable for nanoscale devices and nanoscale dimensions. May 2007 . y Multifunction nanotechnology systems and devices will need new standards. y Measurement techniques and instruments need to be developed and/or standardized. and to develop standards where no TC exists. To support commercialisation and market development To provide a basis for procurement ± technical/quality/environmental management To support appropriate legislation/regulation Challenges: currently there are: y No internationally agreed terminology/definitions for nanotechnology(ies). y No internationally agreed protocols for toxicity testing of nanoparticles. Version 6.
UK proposes CEN/BTWG to develop strategy for European standardization in nanotechnologies.A brief history of standardization for nanotechnologies y 12/03: . y 03/04: Proposal for CEN/BTWG approved ± UK awarded secretariat y 05/04: UK establishes NTI/1 national committee y 08/04: ANSI forms Nanotech Standards Panel in response to a request from OSTP y 10/04: UK starts work on PAS 71 .China implements published nanotech standards .vocabulary for nanoparticles y 11/04: Japan establishes study group for nanotech.ISO ballot on UK proposal approved ± 30 votes to nil Version 6. standardization y 12/04: China publishes 7 national nanotech standards y 01/05: UK submits proposal for an ISO committee y 04/05: .ASTM International approves establishment of E56 committee . May 2007 .China establishes United Working Group for Nanomaterials standardization .
. Singapore (jointly with IEC/TC 113) To date national committees established in Australia.CEN establishes CEN/TC 352 ± Nanotechnologies ± UK Chair & Secretariat y 01/06: UK submits first NWIP to TC 229 ± vocabulary for nanoparticles y 03/06: IEC receives proposal for new TC for Nanotechnologies y 04/06: First meeting of CEN/TC 352 (agreed to collaborate closely with ISO/TC 229) y 05/06: IEC agrees to establish TC 113 in the field of nanotechnologies ± issue of coordination with ISO/TC 229 y 06/06: 2nd meeting of ISO/TC 229. Korea. Singapore. Canada. .UK publishes PAS 71. Tokyo y 12/06: 3rd meeting of ISO/TC 229.CEN/BT/WG 166 delivers European strategy to CEN/BT y 11/05: . May 2007 . Japan. US«««. Germany. Iran. Italy. Russia.Inaugural meeting of ISO TC 229 in London. Berlin y 12/07: 5th meeting of ISO/TC 229. Thailand. UK. vocabulary ± nanoparticles (free from www) .ISO confirms establishment of TC 229 ± UK secretariat & chair. Seoul y 06/07: 4th meeting of ISO/TC 229. China.y 06/05: . Version 6. India. France.
com/nanotechnologies Version 6. RSC.com or see www. ION.cassidy@bsi-global. IoP. FSA. IEC/TC 113 and CEN/TC 352 y Meets four times per year y Members represent key stakeholders from Defra. May 2007 . IOM. y Provides UK input to international committees: ISO/TC 229. NIA. DTI. Terminologies for medical. EA. Qinetiq. CERAM. Durham University. carbon nanostructures. health and personal care applications of nanotechnologies.bsi-global. y For further details contact the secretary Ms Anne Cassidy anne. HSE. and the bio-nano interface). nanomaterials. currently preparing 2 Published Documents (Guide to safe handling and disposal of nanoparticles and Guide to specification of nanomaterials) and 7 PASs (Guide to labelling.HSL.UK NTI/1 Committee (as of September 2006) y Established May 2004 .second (after China) national committee to be formed y Develops national standards and other standardization documents ± 1 published ³Publicly Available Specification´ (PAS) ± PAS 71 vocabulary ± nanoparticles. measurement terms. ««««. nanofabrication.
y Currently 3 New projects: y Format for reporting the engineered nanomaterials content of products (to be published as a CEN/TS). Version 6.European Committee for Standardization committee CEN/TC 352 Nanotechnologies y Established November 2005 following proposal from UK and recommendations from CEN/BTWG 166 y UK Chair and Secretariat y Works closely with ISO/TC 229 and ³topics of mutual interest will be developed under the µVienna Agreement¶ with ISO lead´. y Guide to nanoparticle measurement methods and their limitations (CEN/TR) y Guide to methods for nano-tribology measurements (CEN/TR). y Developing work programme in areas of specific interest to Europe and areas that will be relevant to European legislation. May 2007 .
Asia Nano Forum.iso.TechnicalCommitteeList) y Liaisons with 15 other ISO TCs and 6 external bodies ± IEC/TC 113. May 2007 . CEN/TC 352.Nanotechnologies y Established in June 2005 with UK Chair and Secretariat y 37 members ± 29 ³P´ and 8 ³O´ (see http://www. OECD and VAMAS y Exploring additional external liaisons for emerging economies Version 6. EC JRC.org/iso/en/stdsdevelopment/tc/tclist/Technica lCommitteeList.International Organisation for Standardization committee ISO/TC 229 .
15 ³P´ and 11 ³O´ First meeting March 2007 Agreed to establish two Joint Working Groups with ISO TC/229: y y y JWG 1 ± Terminology and nomenclature JWG2 ± Measurement and characterization WG3 ± Performance Together with a third Working Group: Version 6. May 2007 .International Electrotechnical Commission committee IEC/TC 113 ± ³Nanotechnology standardization for electrical and electronic products and systems´ Established June 2006 with US Chair and German secretariat 26 members .
but not exclusively.´ Note: Scope is further defined by the TC¶s ³Strategy Statement´ Version 6. test methodologies. devices. and science-based health. May 2007 . Utilizing the properties of nanoscale materials that differ from the properties of individual atoms. modelling and simulation. and systems that exploit these new properties Specific tasks include developing standards for: terminology and nomenclature. safety. metrology and instrumentation. typically. including specifications for reference materials. below 100 nanometres in one or more dimensions where the onset of size-dependent phenomena usually enables novel applications. and bulk matter.ISO TC 229 adopted Scope: ³Standardization in the field of nanotechnologies that includes either or both of the following: Understanding and control of matter and processes at the nanoscale. molecules. and environmental practices. to create improved materials.
Safety and Environment (WG 3) ³what effect it might have on health and the environment´ ± Convened by USA PRODUCT AND PROCESS (sc) PRODUCT AND PROCESS (sc) PRODUCT AND PROCESS (sc) Version 6.TC 229 ± Structure/working areas SUPPORT FOR ³REGULATION´ Terminology and Nomenclature (WG 1) ³what you call it´ .Convened by Canada Measurement and Characterization (WG 2) ³How you measure/test it´ ± Convened by Japan Health. May 2007 .
May 2007 .TC 229 Work programme Currently work items: y ³Terminology for nanoparticles´ for publication as an ISO/TS (WG 1) y ³Health and safety practices in occupational settings relevant to nanotechnologies´ for publication as an ISO/TR (WG 3) y ³Endotoxin test on nanomaterial samples for in vitro systems´ for publication as an International Standard (WG 3) New projects: y The Use of Transmission Electron Microscopy in the Characterization of Single-walled Carbon Nanotubes y The use of Scanning Electron Microscopy (SEM) and Energy Dispersive X-ray Analysis (EDXA) of Single Wall Carbon Nanotubes (SWCNTs) y Technical Specification for the Use of UV-Vis-NIR absorption spectroscopy in the Characterization of Single-Walled Carbon Nanotubes (SWCNTs) y Technical Specification for the use of NIR-Photoluminescence (NIR-PL) Spectroscopy in the Characterization of Single-Walled Carbon Nanotubes (SWCNTs) y Generation of silver nanoparticles for inhalation toxicity testing y Monitoring of silver nanoparticles in inhalation exposure chambers for inhalation toxicity testing Version 6.
and 18 were relevant to other Technical Committees. of which y y y y y 2 were relevant to WG 1. Version 6. May 2007 .TC 229 Work programme . 54 were relevant to WG 2. 31 were relevant to WG 3. These results will form the basis of a Road Map for the future work of the committee.2 New Work Item Proposals: y y y Terminology and nomenclature for nanotechnologies ² Framework and core terms Use of Thermo Gravimetric Analysis (TGA) in the purity evaluation of Single Walled Carbon Nanotubes (SWCNT) Use of Evolved Gas Analysis-Gas Chromatograph Mass Spectrometry (EGAGCMS) in the Characterization of Single-Walled Carbon Nanotubes (SWCNTs) In December 2007 ISO/TC 229 completed its first survey of Standardization needs which identified 110 ³high priority´ topics. 5 were relevant to a new WG on materials specifications.
Mar 2007 ENERGY .Current and potential liaisons for ISO/TC 229 ISO/TC 122 ISO/TC 119 ISO/TC 107 Metallic and other inorganic coatings Powder metallurgy 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 MATERIALS ISO/TC 91 Surface active agents BIOMEDICAL ISO/TC 61 Plastics ISO/TC 168 Prosthetics and orthotics EXTERNAL LIAISONS ISO/TC 59 Building construction RISK/HS&E ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems ISO/TC 38 Textiles NANOPARTICLES ISO/TC 215 Health Informatics METROLOGY AND CHARACTERIZATION ISO/TC 225 Market opinion and social research ISO/TC 35 Paints and varnishes ISO/TC 34 Food products ISO/TC 48 Laboratory equipment ISO/TC 215 Environmental management ISO/TC 28 Petroleum and petroleum products ISO/TC 172 Optics and photonics ISO/TC 184 Industrial automation systems and integration ISO/TC 203 Technical energy systems ISO/TC 180 Solar energy version 3. Jan 10 2007 Version 4.
Determination of particle size distribution .IDT y GB/T 20307-2006 General rules for nanometer-scale length measurement by SEM y GB/T 20099-2006 Sample preparation dispersing procedures for powders in liquids Nano-material specificiations: y GB/T19588-2004 Nano-nickel power y GB/T19589-2004 Nano-zinc oxide y GB/T19590-2004 Nano-calcium carbonate y GB/T19591-2004 Nano-titanium dioxide y UK ± PAS 71: 2005 ± Vocabulary ± Nanoparticles Several standards (International. May 2007 .IDT y GB/T 15445.Current nanotechnology standards y Only National standards to date: y China ± 12 National standards published and adopted: Terminology: y GB/T19619-2004 Terminology for nanomaterials Sizing: y GB/T13221-2004 Nanometer powder .Photon correlation spectroscopy (ISO 13321:1996) y GB/T 15445.Small angle X-ray scattering method (ISO/TS13762) y GB/T19587-2004 Determination of the specific surface area of solids by gas absorption using the BET method (ISO 9277:1999) y GB/T19627-2005 Particle size analysis . regional and national) that also apply to the nanoscale y Version 6.4-2006 Representation of results of particle size analysis²Part 2:Characterization of a classification process ISO 9276 4 2001.2-2006 Representation of results of particle size analysis²Part 2:Calculation of average particle sizes/diameters and moments from particle size distributions ISO 9276 2 2001.
allowing earlier publication.qmul. Version 6. y allow documents to be developed in tandem with technology developments rather than trying to shoe horn a new technology into an existing terminology.xalter y For fullerenes (nanoparticles or molecular structures???).bsi-global.uk/iupac/fullerene/#r3 y Chinese National standard for nanomaterials: GB/T19619-2004 Terminology for nanomaterials y ASTM E56 has published a terminology for nanotechnology: E2456-06 Terminology for Nanotechnology y Approach recommended by UK: y Develop series of terminologies/vocabularies in various topic areas.available for free download at http://www.com/Manufacturing/Nano/Download. there is a provisional nomenclature developed by IUPAC http://www.ac. y ISO TC 229 Work Item ³Terminology and definitions for nanoparticles´ approved April 2006.chem.Terminology and nomenclature for nanotechnologies y One current document specific to nanoparticles: y UK PAS 71 . y enable changes in one topic area to be implemented without altering a substantial document. May 2007 . which together will form a terminology for nanotechnologies. This will : y allow consensus to be achieved more easily.
bsi-global.com/nanotechnologies Version 6. May 2007 .Current UK (NTI/1) Work Items 6 sector specific terminologies: y y y y y y Medical. health and personal care applications of nanotechnology The bio-nano interface Carbon nanostructures Nanomaterials Nanofabrication Common nanoscale measurement terms including instrumentation 3 guides y Guide to labelling of manufactured nanoparticles and products containing manufactured nanoparticles y Guide to safe handling and disposal of manufactured nanomaterials y Guide to specifying nanomaterials All documents will be published by the end of 2007 and will be made freely available on the www see www.
y particle shape descriptor. without being so complex as to make it unusable. y composition of any deliberately applied surface layers. which allows as-yet undiscovered entities to be similarly named. y any surface functionalization.g. y core composition and crystal structure. y Perhaps easier to agree an ordered structure for describing nanoparticles containing e. y specific surface area. y must take account of range and complexity of nanoparticles / nanomaterials under consideration. and which ideally allows the nature of all such entities to be determined from their name´ y needs to provide recognisable added value in comparison to existing descriptions. y and particle size distribution. May 2007 .Do we need a nomenclature for nanoparticles (nanomaterials)? y ³a structured naming system that can allocate unique names to unique entities. Version 6.
trapping and destruction of nanoparticles and nanoscale entities. oral and pulmonary exposure to. EPA/NIOSH. in particular for industries dealing with nanoparticles and nanoscale devices. and to characterize nanoscale materials and devices. elimination of. NANOTOX.Pre. nasal. y protocols for whole life cycle assessment of nanoscale materials. y protocols for containment. Work in these areas being undertaken by: SnIRC. CRM. ECVAM. Rice University. INOS. etc.and eco-toxicity testing. including protocols to evaluate effects of short term and long term dermal. y risk assessment tools relevant to the field of nanotechnologies. y Collaboration with OECD Working Party for Manufactured Nanomaterials Version 6. y occupational health protocols relevant to nanotechnologies. May 2007 . Nanosafe2. and fate determination for nanomaterials and nanoscale devices. y protocols for bio. devices and products.and co-normative research requirements: y Critical areas are risk/regulation: Development and delivery needed of: y test methods to detect and identify nanoparticles.
water.Nanomaterial test methods needed for risk assessment/to support possible regulation Particle detection and measurement y Fast. accurate methods for particle ³size´ measurement in air. including any catalytic and enzymatic characteristics y ³bulk´ or ³individual particle´ measurements? y Work relevant to ISO TC 201 ± Surface Chemical Analysis and ISO TC 202 ± microbeam analysis Version 6. sieving and other sizing methods: Particle Characterisation. Size.Sieves. food and the environment: y Specific Surface Area (SSA) y Particle size distribution y Shape factor y Particulate density/Exposure y Work relevant to ISO TC 24 SC4 . May 2007 . Surface area and Zeta potential Identification of composition and surface functionalities.
Biological evaluation of medical devices 207/SC 5 .Environmental management ± life cycle assessment 217.Ultrafine.Air quality (New TR published 2007: Workplace Atmospheres .Food and food products 94 .Implants for surgery 194 .Other ISO TC¶s with an interest in the area of risk and health effects of nanotechnologies y y y y 34 . May 2007 .Inhalation exposure characterization and assessment) 147 .Packaging 146 .Water quality 150 .Cosmetics TMB Working Group on Risk Management (Risk Terminology defined in ISO/IEC Guides 51 & 73) y y y y y y Version 6.Personal safety ± protective equipment 122 . nanoparticle and nano-structured aerosols .
Version 6. to coordinate standards development with relevant TCs. May 2007 . governments.The roles of ISO TC 229. or where the existing TC does not have the necessary resources. OECD. and to develop standards where no TC exists. the European Commission. and the public. IEC TC 113 and CEN TC 352 will be to identify requirements in cooperation with stakeholders. including industry. regulators.
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