Current nanotechnology standardisation activities
The high global interest in the field of nanotechnologies has increased pressure on standard makers to develop deliverables to support commercial and regulatory needs. Standards are technical documents designed to be used as a rule, guideline or definition. They provide a consensus-built, repeatable way of doing something. One of the building blocks of a safe, integrated and responsible approach to the development of nanotechnologies is standardisation. In Europe, both the Economic and Social Committee and the European Parliament have highlighted the importance to be attached to standardisation as a means to accompany the introduction on the market of nanotechnologies and nanomaterials, and as a means to facilitate the implementation of regulation. Standards play a key role for regulatory compliance, in particular in areas where regulation requires a risk assessment and risk management approach.
Standardisation activities in the nanotechnology field are taking place at the international level and in many countries, involving a broad range of interests and organisations. At the forefront of these activities are the following four bodies:
- International Organisation for Standardization (ISO);
- European Committee for Standardization (CEN);
- British Standards Institution (BSI);
- Organisation for Economic Co-operation and Development Working Party on Manufactured Nanomaterials (OECD WPMN).
For each of these bodies, a summary of their current standardisation activities in relation to nanotechnologies is provided in the Standardisation Bodies section below, followed by a list of the key documents published to date. Further information is available on their respective websites.
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Led by TC 229, ISO is currently undertaking standardisation in the field of nanotechnologies that includes either or both of the following:
- Understanding and control of matter and processes at the nanoscale, typically, but not exclusively, below 100 nanometres in one or more dimensions where the onset of size-dependent phenomena usually enables novel applications,
- Utilising the properties of nanoscale materials that differ from the properties of individual atoms, molecules, and bulk matter, to create improved materials, devices, and systems that exploit these new properties.
Specific tasks of ISO TC 229 include developing standards for: terminology and nomenclature; metrology and instrumentation, including specifications for reference materials; test methodologies; modelling and simulations; and science-based health, safety, and environmental practices.
Key standards published by ISO TC 229 to date include:
Physico-chemical Characterisation
Toxicology
Terminology & Definitions
Cross-cutting standards
Further standards for nanotechnologies are currently in various stages of development by ISO TC 229, relating to physico-chemical characterisation, exposure assessment and control, risk assessment and management, terminology and naming, and toxicological testing. A list of draft standards and their stage of development is available on the
ISO website.
CEN established CEN/TC 352 'Nanotechnologies' at the end of 2005 to develop a set of standards addressing the following aspects of nanotechnologies:
- classification, terminology and nomenclature;
- metrology and instrumentation, including specifications for reference materials;
- test methodologies;
- modelling and simulation;
- science-based health, safety and environmental practices;
- nanotechnology products and processes.
Standards in each of these areas could be specific to a product, process or industry. Full details of CEN/TC 352's work programme is available
here.
In February 2010, the European Commission addressed a mandate (
M/461) to CEN, CENELEC (the European Committee for Electrotechnical Standardization) and ETSI (the European Telecommunications Standards Institute) for standardisation activities regarding nanotechnologies and nanomaterials. In the mandate, the Commission requested CEN, CENELEC and ETSI to develop a number of standardisation deliverables, including:
- European standards for methodologies for characterisation of nanomaterials in the manufactured form and prior toxicity and eco-toxicity testing;
- European standards for measurement of exposures to nanomaterials, and;
- European standards for methods to simulate exposures to nanomaterials;
- European standards for occupational handing and exposure, providing guidance on a number of issues including safe handling, dosimetry and exposure determination, detection and identification of nanoparticles and other nanoscale entities.
This mandate will therefore make an important contribution towards the development of standards in relation to providing methods for detection and characterisation of nanomaterials, which will in turn support evaluation of health, safety and environmental impact of nanomaterials in the manufactured form. It is anticipated that standards will begin to emerge from this activity within the next few years, in close collaboration with on-going ISO activities.
UK standardisation in the emerging field of nanotechnologies is the responsibility of the
BSI technical committee NTI/1. This technical committee (TC) was established in June 2004 and has the following Terms of Reference:
- to mirror the work of ISO/TC 229 "Nanotechnologies", IEC/TC 113 "Nanotechnology standardisation for electrical and electronic products and systems" and CEN/TC 352 "Nanotechnologies";
- to formulate a UK strategy for standardization in nanotechnologies through a broad consultation with relevant stakeholders;
- to ensure the UK view is given due consideration within the European Union, CEN, ISO and IEC;
- to develop and support formal standards and other standardization documents in the area of nanotechnologies and to promote their use by industry and other stakeholders;
- to ensure due consideration of the need for standards and standardization is given by UK nanotechnology networks and organisations, and to coordinate activities and actions in this area.
A range of documents have been published by BSI and are available for free download, including:
Terminology & Definitions
Exposure Assessment & Control
Cross-cutting standards
Further documents are under development, which will be published on the
BSI website in due course.
The OECD Working Party on Manufactured Nanomaterials (WPMN) was established in September 2006 as a subsidiary body of the OECD Chemicals Committee. This programme concentrates on human health and environmental safety implications of manufactured nanomaterials (limited mainly to the chemicals sector), and aims to ensure that the approach to hazard, exposure and risk assessment is of a high, science-based, and internationally harmonised standard. This programme promotes international co-operation on the human health and environmental safety of manufactured nanomaterials, and involves the safety testing and risk assessment of manufactured nanomaterials.
The OECD WPMN has published a series of guidance documents, listed below, which are available for free download from the
OECD website.
Although the documents published to date are guidance documents rather than standards, OECD does publish standards and is active in the nanotechnology field. It is therefore to be expected that standards will be developed and published by OECD in the future. Further details will be included here as and when they are available.
Published OECD guidance documents:
- No. 29 - ENV/JM/MONO(2011)12 - Current Developments/Activities on the Safety of Manufactured Nanomaterials
- No. 28 - ENV/JM/MONO(2010)47 - Compilation and Comparison of Guidelines Related to Exposure to Nanomaterials in Laboratories
- No. 27 - ENV/JM/MONO(2010)46 - List of Manufactured Nanomaterials and List of Endpoints for Phase One of the Sponsorship Programme for the Testing of Manufactured Nanomaterials: Revision
- No. 26 - ENV/JM/MONO(2010)42 - Current Developments/Activities on the Safety of Manufactured Nanomaterials, Tour de Table at the 7th Meeting of the Working Party on Manufactured Nanomaterials
- No. 25 - ENV/JM/MONO(2009)20/REV - Guidance Manual for the Testing of Manufactured Nanomaterials: OECD Sponsorship Programme: First Revision
- No. 24 - ENV/JM/MONO(2010)25 - Preliminary Guidance Notes on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials
- No. 23 - ENV/JM/MONO(2010)12 - Report of the Questionnaire on Regulatory Regimes for Manufactured Nanomaterials (2010)
- No. 22 - ENV/JM/MONO(2010)11 - OECD Programme on the Safety of Manufactured Nanomaterials 2009-2012 Operational Plans of the Projects
- No. 21 - ENV/JM/MONO(2010)10 - Report of the Workshop on Risk Assessment of Manufactured Nanomaterials in a regulatory context, held on 16-18 September 2009, in Washington D.C.,United States
- No. 20 - ENV/JM/MONO(2010)4 - Current Developments/Activities on the Safety of Manufactured Nanomaterials: Tour de Table at the 6th Meeting of the Working Party on Manufactured Nanomaterials, 28-30 October 2009
- No. 19 - ENV/JM/MONO(2009)45 - Analysis of Information Gathering Initiatives on Manufactured Nanomaterials
- No. 18 - ENV/JM/MONO(2009)34 - Manufactured Nanomaterials: Roadmap for Activities during 2009 and 2010
- No. 17 - ENV/JM/MONO(2009)23 - Current Developments in Delegations and other International Organisations on the Safety of Manufactured Nanomaterials- Tour de Table
- No. 16 - ENV/JM/MONO(2009)22 - Manufactured Nanomaterials: Work Programme 2009- 2012
- No. 15 - ENV/JM/MONO(2009)21 - Preliminary Review of OECD Test Guidelines for their Applicability to Manufactured Nanomaterials
- No. 14 - ENV/JM/MONO(2009)20 (This document has been updated) - Guidance Manual for the Testing of Manufactured Nanomaterials: OECD's Sponsorship Programme
- No. 13 - ENV/JM/MONO(2009)18 - Report of an OECD Workshop on Exposure Assessment and Exposure Mitigation: Manufactured Nanomaterials
- No. 12 - ENV/JM/MONO(2009)17 - Comparison of Guidance on Selection of Skin Protective Equipment and Respirators for Use in the Workplace: Manufactured Nanomaterials
- No. 11 - ENV/JM/MONO(2009)16 - Emission Assessment for Identification of Sources and Release of Airborne Manufactured Nanomaterials in the Workplace: Compilation of Existing Guidance
- No. 10 - ENV/JM/MONO(2009)15 - Identification, Compilation and Analysis of Guidance Information for Exposure Measurement and Exposure Mitigation: Manufactured Nanomaterials
- No. 9 - ENV/JM/MONO(2009)10 - EHS Research Strategies on Manufactured Nanomaterials: Compilation of Outputs
- No. 8 - ENV/JM/MONO(2009)6 - Preliminary Analysis of Exposure Measurement and Exposure Mitigation in Occupational Settings: Manufactured Nanomaterials
- No. 7 - ENV/JM/MONO(2008)29 - Current Developments/ Activities on the Safety of Manufactured Nanomaterials: Tour de Table at the 4th Meeting of the Working Party on Manufactured Nanomaterials, 11-13 June 2008
- No. 6 - ENV/JM/MONO(2008)13/REV (This document has been updated) - List of Manufactured Nanomaterials and List of Endpoints for Phase One of the OECD Testing Programme
- No. 5 - ENV/JM/MONO(2008)7 - Current Developments/ Activities on the Safety of Manufactured Nanomaterials: Tour de Table at the 3rd Meeting of the Working Party on Manufactured Nanomaterials, 28-30 November 2007
- No. 4 - ENV/JM/MONO(2008)2 - Manufactured Nanomaterials: Programme of Work 2006-2008
- No. 3 - ENV/JM/MONO(2007)16 - Current Developments/ Activities on the Safety of Manufactured Nanomaterials: Tour de table at the 2nd Meeting of the Working Party on Manufactured Nanomaterials, 25-27 April 2007
- No. 2 - ENV/JM/MONO(2006)35 - Current Developments/ Activities on the Safety of Manufactured Nanomaterials: Tour de table at the 1st Meeting of the Working Party on Manufactured Nanomaterials, 26-27 October 2006
- No.1 - ENV/JM/MONO(2006)19 - Report of the OECD Workshop on the Safety of Manufactured Nanomaterials: Building Co-operation, Co-ordination and Communication, 7-8 December 2005.