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Posted: May 16, 2008

Nanotechnology standards

(Nanowerk Spotlight) Most people in the world know exactly how long a kilometer is, how large a liter is, how much a kilogram weighs, and how warm 25°C is. That's because almost all countries in the world have adopted a standard called the metric system - since the 1960s the International System of Units has been the internationally recognized standard system for measurements (only three countries have not adopted this standard: Liberia, Myanmar, and the United States - the latter maybe because the metric system was invented by the French...). The lack of a unified standard, or the existence of different standards, can have dire consequences. A few years ago, the Mars Climate Orbiter spacecraft was destroyed because a navigation error caused the spacecraft to fly too deep into the atmosphere of Mars. This error arose because a NASA subcontractor used Imperial units (pound-seconds) instead of the metric units (newton-seconds) as specified by NASA. But even in the U.S., economic and scientific needs assure the continued creeping adoption of the metric standard in various areas. Nanotechnology is such a case, were the metric system is the undisputed only standard - used even by U.S. researchers - and sparing us conversion tables for nanometer to nanoinch and nanofoot, and nanoliter to nanogallon.
Standards have a much larger role in our society than just agreeing measurements. As the British Standards Institution (BSI) explains it, put at its simplest, a standard is an agreed, repeatable way of doing something. It is a published document that contains a technical specification or other precise criteria designed to be used consistently as a rule, guideline, or definition. Standards help to make life simpler and to increase the reliability and the effectiveness of many goods and services we use. They are intended to be aspirational – a summary of good and best practice rather than general practice.
Standards are designed for voluntary use and do not impose any regulations. However, laws and regulations may refer to certain standards and make compliance with them compulsory. For example, the physical characteristics and format of credit cards is set out in standard number BS EN ISO/IEC 7810:1996. Adhering to this standard means that the cards can be used worldwide.
The need for standardization also exists in various fields of nanotechnology in order to support commercialization and market development, provide a basis for procurement, and support appropriate legislation/regulation. The lack of nanotechnology standards poses several major challenges because right now there are:
  • no internationally agreed terminology/definitions for nanotechnology
  • no internationally agreed protocols for toxicity testing of nanoparticles
  • no standardized protocols for evaluating environmental impact of nanoparticles
  • no standardized measurement techniques and instruments
  • no standardized calibration procedures and certified references materials.
  • If we didn't have standards in our everyday lives, from things like coffemakers to cell phones, CDs and cars, life would be pretty complicated and much more expensive. Just think about the inconvenience every international traveler has experienced when it comes to the international incompatibility of plugs and sockets.
    Standards create comparability and any standard is a collective work. Committees of manufacturers, users, research organizations, government departments and consumers work together to draw up standards that evolve to meet the demands of society and technology.
    Standards exist at different levels and with different scopes: national standards such as ANSI in the U.S. or DIN in Germany; regional standards such as the EN standards in the European Union or the standards set by the Pan American Standards Commission; and international standards such as the IEC and ISO standards that are recognized by a large number of countries around the world.
    When it comes to nanotechnology, numerous standard setting organizations around the world are active in defining nanotechnology standards, although no one standard has achieved dominance yet. Some examples:
  • ANSI-Nanotechnology Standards Panel in the U.S.
  • ASTM Committee E56 on Nanotechnology
  • BSI British Standards Committee for Nanotechnologies (NTI/1)
  • European Committee for Standardization (CEN) 'work program Nanotechnologies' (CEN/TC 352)
  • IEC group for nanotechnology standardization for electrical and electronic products and systems (TC 113)
  • IEEE Nanotechnology Standards Working Group
  • ISO Technical Committee on Nanotechnologies (TC 229)
  • Interestingly, China took the early lead in being first to establish its United Working Group for Nanomaterials standardization in December 2003. Here is a brief history of standardization for nanotechnologies:
    March 2004Proposal for CEN/BTWG approved UK awarded secretariat
    May 2004UK establishes NTI/1 national committee
    August 2004ANSI forms Nanotechnology Standards Panel in the U.S.
    October 2004UK starts work on PAS 71 – vocabulary for nanoparticles
    November 2004 Japan establishes study group for nanotechnology standardization
    December 2004China publishes 7 national nanotechnology standards
    January 2005UK submits proposal for an ISO nanotechnology committee
    April 2005China implements published nanotechnology standards; ASTM International approves establishment of E56 committee
    June 2005ISO confirms establishment of TC 229 ; UK publishes PAS 71, vocabulary; CEN/BT/WG 166 delivers European strategy to CEN/BT
    November 2005 Inaugural meeting of ISO TC 229; CEN establishes CEN/TC 352 Nanotechnologies
    January 2006UK submits first NWIP to TC 229 – vocabulary for nanoparticles
    April 2006First meeting of CEN/TC 352 (agreed to collaborate closely with ISO/TC 229)
    May 2006IEC agrees to establish TC 113 in the field of nanotechnologies
    Throughout 20072nd, 3rd, 4th and 5th meting of ISO/TC 229
    January 2008 BSI publishes 6 terminology publications and 3 other guidance documents
    Source: Dr Peter Hatto, Chairman UK NTI/1 and ISO TC 229 Nanotechnologies Standardization committees, in: "An introduction to standards and standardization for nanotechnologies"
    One of the first tasks on everyone's plate – and the fundamental building block for any emerging industry – is a consistent and globally-accepted nomenclature and terminology. Without a precise and widely accepted terminology, communications about nanotechnology's risks and benefits are riddled with overgeneralizations. For example, the term 'carbon nanoparticles' often is used to describe in one phrase a range of very diverse nanomaterials such as fullerenes, single-, double-, or multi-walled carbon nanotubes, and even diesel exhaust.
    Following the nanotechnology terminology, the next requirements on everyone's list are specifications and tests needed to support nanoscale measurement and characterization; as well as how nanotechnology will impact health, safety and the environment.
    Ultimately, nanotechnology will require agreed international standards. The UK's BSI is playing a key role in leading the development of nanotechnology standards through its national committee NTI/1 Nanotechnologies and it holds both the chair and secretariat of ISO TC/229 Nanotechnologies and CEN/TC 352 Nanotechnologies.
    An example of the emerging body of nanotechnology standards are the BSI's publication of nine documents for nanotechnology terminology and guidance for industry, addressing nanotechnology terminology, health and safety issues, and product labeling:

    PAS 131, Terminology for medical, health and personal care applications of nanotechnologies;

    PAS 132, Terminology for the bio-nano interface;

    PAS 133, Terminology for nanoscale measurement and instrumentation;

    PAS 134, Terminology for carbon nanostructures;

    PAS 135, Terminology for nanofabrication;

    PAS 136, Terminology for nanomaterials.

    PD 6699-1, Nanotechnologies Part 1: Good practice guide for specifying manufactured nanomaterials

    PD 6699-2, Nanotechnologies Part 2: Guide to safe handling and disposal of manufactured nanomaterials

    PAS 130, Guidance on the labeling of manufactured nanoparticles and products containing manufactured nanoparticles

    All nine publications are available to download from BSI's website.
    Globally accepted nanotechnology standards will support worker, public and environmental safety and underpin commercialization and procurement of nanotechnologies in various industries. Given the current discussion about the potential risks of engineered nanomaterials, one of the key functions of nanotechnology standards will be the safety aspect of products. Today, products that contain nanomaterials, especially in the food and cosmetics industry, don't require any special labeling. Once the appropriate standards have been developed and accepted, product labels could refer to these standards, assuring the consumer that this particular product has undergone rigorous safety testing based on best practice and is considered safe.
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