ABSTRACT
Before 2005 more or less no internationally agreed terminologies and/or definitions for nanotechnology, protocols for toxicity testing of nanoparticles, or protocols for evaluating environmental impact of nanoparticles existed. Some existing standards are, or might be, applicable to characterize nanomaterials, e.g. standards for chemical analysis and imaging (developed by ISO TCs 201 and 202) or in the field of particle detection or sizing (ISO TC 24). A few already existing test methods might be suitable for nanoscale devices and in nanoscale dimensions. But their application on the nanoscale has to be proofed and standardized, especially specific sampling or preparation techniques. Consequently there is a strong demand to develop and standardize new measurement techniques and instruments. New calibration procedures and certified references materials (CRMs) are needed to validate test instruments in the nanoscale. Multifunction nanotechnology systems and devices will need new standards. After some preliminary activities the intensive process of international standardization of nanotechnological issues started at the end of 2005 by launching the new committees ISO/TC 229, IEC/ TC 113, and CEN/TC 352, all of them entitled “Nanotechnologies”. ISO/TC 229 is the most active committee and had its inaugural
meeting in London (November 2005), followed by a six-month period of meetings in Tokyo (June 2006), Seoul (December 2006), Berlin (June 2007), Singapore (December 2007), Bordeaux (May 2008), Shanghai (November 2008), Seattle (June 2009), Tel Aviv (October 2009), Maastricht (May 2010), Malaysia (December 2010), St. Petersburg (May 2011), Johannesburg (November 2011), and Stresa (June 2012). There is a large, still increasing number of participating (34) or observing (19) countries and participating experts (between 120 and 150). Many other TCs in ISO, IEC, and CEN also handle topics related to the nanoscale. Therefore ISO/TC 229, IEC/TC 113, and CEN/TC 352 had established a number of liaisons to convey the cooperation between those and to avoid duplication of work. 1.1.3 Importance of the Definition of the Term
Since the beginning of the trend to develop materials, processes, measurement techniques, etc., in the nanoscale accompanied by the introduction of the term “nanotechnology”, which is sometimes called the “nanotech hype”, the discussion on potential new risks associated with this new technology area increased. Public perception and political action focus mainly on the impact of nanomaterials to health, environment, and safety. The intensity is different, but it happens in all regions of the industrial world. Therefore nationwide organizations such as OECD, trade zones such as the EU, and individual countries have already implemented-or plan to develop-regulations on nanomaterials. Life would be much easier if the internationally agreed definition of the term “nanomaterial” would be referenced by those organizations and countries for regulative purposes. The European Commission Joint Research Centre had published their “Considerations on a Definition of Nanomaterial for Regulatory Purposes” [4] in 2010. They discussed the need for a definition of the term nanomaterial and compared the different existing international and national definitions. One of the goals of the international standardization process in ISO had been the definition of internationally agreed terms in the field of nanotechnologies. The status quo shows unfortunately that
in many cases regulative documents (already published or planned) use different definitions of the term nanomaterial. Examples will be discussed in Section 1.3.1.4.
