Nanotechnology Standards

A standard can be understood as a rule, norm or requirement that is broadly established chiefly by authority, custom or consent. The American National Standards Institute (ANSI) classifies standards by function or origin into eight types: basic, product, design, process, specification, code, management system and personnel certification standard [1]. Historically, standards were developed in limited geographies in parallel with man’s own technical development by common use and early custom.

At the time of writing this chapter, early in 2010, several reports have been issued that differ in definitions used for nanotechnology, which is not unusual considering the large number of conferences, reports, papers and presentations given each year on this subject. It is in fact very difficult to follow developments in this field, and the multidisciplinary nature of nanotechnology almost invites a similar multiplicity of definitions as each specialty (or scientific discipline) adjusts to the new findings of what is a dynamic research effort. However, the same dynamism leads to ambiguity in meanings and to uncertainty in the overall impact this field will have when products are commercialized. In this chapter, we will be visiting the several dimensions, societal, governmental and technical, and thereby highlighting the challenges facing terminology and nomenclature efforts.

Globalisation of both science and trade has increased the relevance of the ­comparability of measurement data whether in research, industry or regulatory contexts. Reference materials (RMs) are essential tools in the quest for comparable and reliable measurement results, a quest which laboratories, worldwide, are tasked with every day. An explicit acknowledgement of the importance of RMs in today’s measurement systems is found, for instance, in the laboratory accreditation standards, such as ISO/IEC 17025 [1].

Nanotechnology is generally defined as the study, exploitation and/or manipulation of matter with size range from approximately 1 to 100 nm. The focus of nanotechnology is largely on the new and novel properties and/or functionalities of traditional substances when they have structures of nano-scale dimensions. Science continues to push frontiers of knowledge, and the transformation of science into technology is underpinned by profound understanding and predictive models, which can only be attained via measurement results which are widely reliable and comparable. Therefore, measurement science and metrology are essential for nanoscale manufacturing of new materials, devices and products.

Nanotechnology is emerging now as a technology from the fundamental research stage, so an obvious question to ask is: Is nanotechnology too premature for standardization? The answer will be a clear NO!

This chapter briefly describes current standardization activities for measurement and characterization of nanotechnology in various standardization organizations, with emphasis on the activity of ISO (International Organization for Standardization). Since the establishment of the U.S. National Nanotechnology Initiative (NNI) in 2001, both industrial and developing countries have accelerated investment for research and development (R&D) of nanotechnology [1]. In accordance with the increase in attention to nanotechnology worldwide, the interest in standardization for nanotechnology became prominent in 2004 in a trilateral framework involving the U.S., Europe, and Asia.

Nanotechnology as a concept is usually credited to Feynman [1] who presented the idea in a 1959 after-dinner speech entitled, “There’s plenty of room at the bottom.” Interest in nanotechnology at the national level grew to the point that the United States Government launched the National Nanotechnology Initiative (NNI) in 1999 [2]. From a programmatic standpoint, materials related disciplines were combined using the unifying principle that some feature of the material should fall within the nanoscale size range. Nanoscale is defined as the size from approximately 1–100 nm [3]. Also some well-known materials associated with nanotechnology, such as fullerene and single wall carbon nanotubes were discovered in only the last 25 years [4, 5]. Much of the supporting science is well established in fields such as electronics, polymers, powders, colloids, and aerosols. However, the nanotechnology field is currently expanding rapidly with the discovery of new techniques, insights, applications and materials. It is clear that unifying principles and appropriate standards need to be developed to allow a systematic approach to managing the applications and risks of nanotechnology. These challenges have been faced by ISO Technical Committee 229 “Nanotechnologies” in its program to develop documents consistent with the goals of international standardization. The purposes of international standardization are to facilitate international trade; improvement of quality, safety, security, environmental and consumer protection, as well as the rational use of natural resources; and global dissemination of technologies and good practices [6].

For the first time in the history of industrialization, nanotechnology offers the unique opportunity to consider material safety concerns prior to widespread adoption and use by industry. Many scientists around the world have been motivated by this and are working on developing and applying nanotechnology as safely as ­possible, attempting to avoid the pitfalls of our earlier introductions of new chemicals and chemical processes into commerce. One key aspect of defining the safety of any chemical product, whether nano-sized or conventional, is toxicity testing and the determination of hazard potential during manufacturing and/or use.

Health and safety standards aim at minimizing risk to people and the environment. Often, though, there is a significant time lag between the emergence of any new technology and the generation of sufficient risk information to allow a thorough risk assessment and to write a traditional regulatory quantitative risk management standard [1]. In the early twenty-first century, this time lag is leading society to aim to proactively manage the risks of emerging technologies like nanotechnology [2]. Proactive risk management can serve as an initial response to a new technology and later can lead to traditional regulatory standards that are based on lengthy risk assessment data collection. Proactive risk management should include, at a minimum, the following essential features (1) qualitative – as opposed to quantitative – risk assessment; (2) strategies to quickly adapt to accumulating risk information as it develops and to refine any risk management recommendations; (3) recommendations based on a level of precaution that is appropriate to ensure no material impairment of human or environmental health occurs from exposure to the new technology; (4) steps that are equivalent across the spectrum of global emerging technology firms; and (5) robust stakeholder involvement that can lead to widespread voluntary cooperation between firms [2]. These features of proactive risk management are particularly applicable for the development of health and safety standards for the rapidly emerging field of nanotechnology.

Many emerging technologies of the last century have been structured or defined through the standards development process, sometimes either preceded or eventually followed by adaptations in the law.