Working with nanotechnologies has provided unique solutions for several industries but requires new quality, safety and testing standards, as Dr Peter Hatto, chairman of various BSI, CEN and ISO nanotech committees, explains.
Despite their virtual invisibility to the man in the street, voluntary, consensus-based, documentary standards are absolutely vital to the smooth and efficient operation of industry, commerce and regulation. By providing agreed ways of naming, describing and specifying things, measuring and testing things, managing things, and means to ensure health and environmental safety, documentary standards support innovation, commercialisation, market development and established markets, and provide a basis for procurement together with support for legislation and regulation.
In the new and emerging field of nanotechnologies, where nanoscale-related phenomena are predicted to have a major impact on virtually all areas of human endeavour, consensus-based standards will be essential to provide underpinning support for both r&d and commercialisation in relevant areas.
In particular, agreements on terminology and definitions, measurement and characterisation protocols, and protocols for occupational and environmental health and safety will be critical to helping to ensure that nanotechnologies develop in an open, safe and responsible manner.
At the current time, nanotechnologies standardisation activities are primarily devoted to developing “horizontal standards”, i.e. documents that provide a common and harmonised foundation for product-related and sector-specific standards. For the UK, these horizontal standards are being developed within three separate committees. These are the UK committee BSI NTI/1, the European Committee for Standardisation (CEN) TC 352, and the International Organisation for Standardisation (ISO) committee ISO TC 229. The development of UK national standards in the area started more than five years ago with the establishment of the NTI/1 committee. Since that time the committee has published 10 documents, seven terminologies and three guides – to safe handling and disposal of nanomaterials, specifying nanomaterials, and to labelling of nanomaterials (see annex 1) – which are all available for free download from the BSI website.
All of these documents have been used either as the basis for new work item proposals for work in the CEN or ISO committees or as contributions to existing work items in these committees. NTI/1 is currently engaged in the development of guidance documents for assessing occupational exposure to nanomaterials and for small and medium sized enterprises (SMEs) to standards and regulations relevant to nanotechnologies. The website referred to above provides further details of the committee and its work, as well as useful information and news on nanotechnologies.
The International Organisation for Standardisation Technical Committee (ISO/TC) 229 Nanotechnologies was established in June 2005 with a UK secretariat and chair. The ninth meeting of the committee took place in Tel Aviv, Israel, in October 2009. The committee currently has 41 members – 32 “P” and 9 “O”. The first two documents developed by the committee were published in 2008: DD CEN ISO/TS 27687 – Nanotechnologies. Terminology and definitions for nano-objects – nanoparticle, nanofibre and nanoplate; and PD ISO/TR 12885 Nanotechnologies. Health and safety practices in occupational settings relevant to nanotechnologies.
The TC structure consists of four working groups (WG), the first two of which are Joint Working Groups (JWG) with IEC/TC 113 (Nanotechnology standardisation for electrical and electronic products and systems): Terminology and Nomenclature (JWG1, convened by Canada); Measurement and Characterisation (JWG2, convened by Japan); Health, Safety and Environmental Aspects of Nanotechnologies (WG3, convened by the USA), and Material Specifications (WG4, convened by China). The work programme currently contains 37 work items – 7 in JWG1, 15 in JWG2, 9 in WG3, 5 in WG4 and 1 unallocated (see Annex 2).
The committee has Task Groups that are developing recommendations as to how it should address the areas of Nanotechnologies and Sustainability, and Consumer and Societal Dimensions of Nanotechnologies. The work of these Task Groups is essential to ensure that committee documents take these important issues into account, and should prove valuable in helping to ensure that nanotechnologies deliver a major contribution to significant global challenges, energy, water and sustainability, that many people predict.
The TC works closely with the International Electrotechnical Commission (IEC) TC 113, chaired by the US, with Germany providing the secretariat. The two Technical Committees hold joint plenary meetings at least every two years, starting in December 2007. TC 229 also works closely with the CEN TC in the area (TC 352 – Nanotechnologies, also chaired by UK), using the Vienna agreement where appropriate. Liaisons have been established with 25 other ISO TCs, with the OECD (Working Party on Manufactured Nanomaterials and Working Party on Nanotechnology), the International Bureau of Weights and Measures (BIPM), the EC Joint Research Centres (IRMM and Institute for Health and Consumer Protection, Ispra), International Union of Pure & Applied Chemistry (IUPAC), the Asia Nano Forum and the Versailles Project on Advanced Materials and Standards (VAMAS).
Given the number of ISO and other committees and working parties with an interest in nanotechnologies, standardis-ation and test methods for measurement and characterisation, the committee has established a Nanotechnology Liaison Co-ordination Group to ensure the co-ordination of activities and deliverables amongst liaison organisations. Meetings of this group are held during the twice-yearly plenary meetings of ISO/TC 229.
CEN/TC 352 was established at the end of 2005 to develop standards of specific interest to Europe and the European single market. It has two working groups: WG1 ‘Measurement, characterisation and performance evaluation’; and WG2 ‘Commercial and other stakeholder aspects’. All of its work to date has been undertaken jointly with ISO/TC 229 under the terms of the Vienna Agreement, with three items led by CEN and the others by ISO. The committee is currently awaiting a response from the European Commission to a report on “the elaboration of a programme of standards to take into account the specific properties of nanotechnology and nanomaterials”, which it prepared on behalf of the European standardisation bodies (CEN, CENELEC and ETSI) and which was submitted in May 2008.
The response is expected to include a programming mandate that will identify standards of particular interest to the Commission. CEN/TC 352 is also working with the NMP division of DG Research to identify outputs of Framework projects that might be suitable for standardisation.
In view of the strict time limits on the development of projects in ISO and CEN, all of the projects identified in the Annex will either be published sometime within the next three years or be deleted from the work programmes.
ISO/CEN agreement on technical co-operation
The Vienna Agreement between CEN and ISO allows for joint working on topics of mutual interest. Under the terms of the agreement, such projects are developed in one or other organisation (the lead committee) with the other providing input, where appropriate, while agreeing not to undertake work in the area (“stand still”). The final draft is balloted through both committees in the usual way and can be adopted by one or other, both or neither committee. If confirmed by both committees the document is published as a CEN/ISO, whereas if confirmed by only one of the committees, it is published as either a CEN or ISO document, depending on which committee approves it. The process is primarily intended for the development of full CEN (EN – European Norm) and ISO (IS – International Standard) standards but can also be used, with appropriate justification, for the development of Technical Specifications.
The author
Dr Peter Hatto, Director of Research, IonBond, Chairman of BSI/NTI/1, CEN/TC 352 and ISO/TC 229 standardisation committees for nanotechnologies