Nanotechnology standardization: Challenges, current status and perspectives

Abstract

After more than 20 years of vigorous development, nanotechnology has been applied to many a fields, such as building materials, clothing, electronics, information, medicine, energy and environment, etc. The scale of the nanotechnology industry continues to expand. According to the statistics results, there are more than 1600 nanotechnology-based products in the global market. Technical standards provide important support and guarantee for scientific achievements entering market and forming industries. Efficient standard system can meet the standardization requirements from each stage of industrial chain, from preparation of nanomaterials to final products, thus help improving research and development efficiency and the development of industrial. In the past industrial economy era, standards often lag behind the production and large-scale application of products, while in the current era of knowledge-based economy, leading enterprises try to formulate and control standards in the early stage of industrialization to maximize the benefits. Nanotechnology with rapid development is in urgent need of standardization in the following four aspects: terminology and nomenclature, measurement and characterization, health, safety and environmental, and material specifications. (1) We all know that nanotechnology practitioners come from different disciplines and industries. In order to avoid misunderstanding and establish a consistent basis for information exchange, it is necessary to establish terms and definitions. The main contents of the standardization of terminology and nomenclature includes classification and nomenclature of materials, definition of core terms and derived terms, establishment of terminological framework and system, etc. ISO/TC229-IEC/TC113-JWG1 has classified nanotechnology into different areas and defined basic terms of these areas within the overall framework of nanotechnology. Currently, the famous ISO 80004 series have been developed, which includes 13 parts. (2) Measurement and characterization standardization guarantee reliable and comparable measurement results. The validation and comparison of large number of data in nano-field need scientific and unified characterization standard. Measurement results of key characteristics directly affect the trade of nanomaterials between up- and down-stream vendors. ISO/TC229-IEC/TC113-JWG2 focuses on establishing different levels of measurement and characterization standards for each class of nanomaterials. There are about 30 standards that have been published and under development in ISO/TC229-IEC/TC113-JWG2. These standards are mainly focused on matured measurement techniques. (3) Health, safety and environmental aspect standardization of nanotechnology is to ensure the sustainable development of occupational health, environment and public safety. It mainly involves nanotoxicology testing standards, occupational exposure dose data collection and control. ISO/TC229/WG3 works on the standard development of this area. Standards developed in this area are mainly led by developed countries, such as the USA, Canada, etc. (4) Material specifications in nanotechnology refers to the standardization of the critical characteristics that must be achieved in nano-products, nanomaterials, nano-manufacturing processes as well as measurement methods to determine these characteristics. ISO/TC229/ WG4 works on the development of material specifications. WG4 mainly focus on classification of nanomaterials, selection of proper characteristics, evaluation of the maturity of the market, and find proper standard measurement methods for the selected characteristics. The development of nanotechnology standardization confronts great challenges. Further development in this area depends on deep research in fields of measurement method validation, uncertainty evaluation, reference material development, etc. as well as close cooperation among academia, industry and regulators. This article reviews the current state of nanotechnology industry standardization. Specifically, strategy design, standardization organizations, standards that have published and being developed and major challenges are elaborated. Furthermore, possible strategies are also proposed base on the nanotechnology development in our country. It is hoped that by strengthening top-level design and publicity efforts, improved enterprises' participation in standardization activities, elevated standardization quality and boosted development of nano-enterprises will be achieved in our country.