Overview of Standards Related to the Occupational Risk and Safety of Nanotechnologies
1.1. Overview of Nanotechnology in the World
1.2. International Standards for Risk and Safety in Nanotechnology
- ISO/TR 13121:2011. Nanotechnologies—Nanomaterial risk evaluation. ISO/TR 13121:2011 describes a process for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials in order to protect the health and safety of the public, consumers, workers, and the environment. ISO/TR 13121:2011 offers guidance on the information needed to make sound risk evaluations and risk management decisions, as well as how to manage in the face of incomplete or uncertain information by using reasonable assumptions and appropriate risk management practices. Further, ISO/TR 13121:2011 includes methods to update assumptions, decisions, and practices as new information becomes available and on how to communicate information and decisions to stakeholders. ISO/TR 13121:2011 suggests methods that organizations can use to be transparent and accountable in how they manage nanomaterials. It describes a process of organizing, documenting, and communicating what information organizations have about nanomaterials [10,11].
- ISO/TS 12901-1:2012. Nanotechnologies—Occupational risk management applied to engineered nanomaterials—Part 1: Principles and approaches. ISO/TS 12901:2012 provides guidance on occupational health and safety measures relating to engineered nanomaterials, including the use of engineering controls and appropriate personal protective equipment, guidance on dealing with spills and accidental releases, and guidance on the appropriate handling of these materials during disposal. ISO/TS 12901-1:2012 is intended for use by competent personnel, such as health and safety managers, production managers, environmental managers, industrial/occupational hygienists, and others with responsibility for the safe operation of facilities engaged in the production, handling, processing, and disposal of engineered nanomaterials. ISO/TS 12901-1:2012 is applicable to engineered materials that consist of nano-objects such as nanoparticles, nanofibres, nanotubes, and nanowires, as well as aggregates and agglomerates of these materials (NOAA) [10,12].
- ISO/TR 13329:2012—Nanomaterials—Preparation of the material safety data sheet (MSDS). This document provides guidance on the development of content for, and consistency in, the communication of information on safety, health, and environmental matters in safety data sheets (SDS) for substances classified as manufactured nanomaterials and for chemical products containing manufactured nanomaterials. It provides supplemental guidance to ISO 11014:2009 (Safety data sheets for chemical products) on the preparation of SDSs generally, addressing the preparation of an SDS for both manufactured nanomaterials with materials and mixtures containing manufactured nanomaterials [4,13].
- ISO/TS 12901-2:2014. Nanotechnologies—Occupational risk management applied to engineered nanomaterials—Part 2: Use of the control banding approach. ISO/TS 12901-2:2014 describes the use of a control banding approach for controlling the risks associated with occupational exposures to nano-objects and their aggregates and agglomerates greater than 100 nm (NOAA), even if knowledge regarding their toxicity and quantitative exposure estimations is limited or lacking. The ultimate purpose of control banding is to control exposure in order to prevent any possible adverse effects on workers’ health. The control banding tool described here is specifically designed for inhalation control. Some guidance for skin and eye protection is given in ISO/TS 12901 1. ISO/TS 12901-2:2014 is focused on intentionally produced nano-objects, such as nanoparticles, nanopowders, nano fibres, nanotubes, and nanowires, as well as on aggregates and agglomerates of the same. As used in ISO/TS 12901-2:2014, the term NOAA applies to such components, whether in their original form or incorporated in materials or preparations from which they could be released during their lifecycle. ISO/TS 12901-2:2014 is intended to help businesses and others, including research organizations, engaged in the manufacturing, processing, or handling of NOAA, by providing an easy-to-understand, pragmatic approach for the control of occupational exposures [10,14].
- ISO/TR 12885:2018. Nanotechnologies—Health and safety practices in occupational settings. This document describes the health and safety practices in occupational settings relevant to nanotechnologies. This document focuses on the occupational manufacturing and use of manufactured nano-objects and their aggregates and agglomerates greater than 100 nm (NOAAs). It does not address health and safety issues or practices associated with NOAAs generated by natural processes, hot processes, and other standard operations which unintentionally generate NOAAs or potential consumer exposures or uses, although some of the information in this document can be relevant to those areas [10,15].
- EN ISO 28439:2011—Workplace atmospheres—Characterization of ultrafine aerosols/nanoaerosols—Determination of the size distribution and number concentration using differential electrical mobility analyzing systems (ISO 28439:2011)
- EN 17058:2018—Workplace exposure—Assessment of exposure by inhalation of nano-objects and their aggregates and agglomerates
- EN 16966:2018—Workplace exposure—Measurement of exposure by inhalation of nano-objects and their aggregates and agglomerates—Metrics to be used such as number concentration, surface area concentration, and mass concentration
- EN 16897:2017—Workplace exposure—Characterization of ultrafine aerosols/nanoaerosols—Determination of the number concentration using condensation particle counters
- CEN ISO/TS 21623:2018—Workplace exposure—Assessment of dermal exposure to nano-objects and their aggregates and agglomerates (NOAA) (ISO/TS 21623:2017)
2. Control Banding Approach in Occupational Risk Management Applied to Engineered Nanomaterials
- Information gathering;
- Assignment of the nano-objects to a hazard band (on the basis of a comprehensive evaluation of all available data on each material, taking into account parameters such as toxicity; in vivo biopersistence; and factors influencing the ability of particles to reach the respiratory tract, their ability to deposit in various regions of the respiratory tract, and their ability to elicit biological responses);
- Description of potential exposure characteristics (assigning an exposure scenario at a workplace to an exposure band, taking into account the physical form and amount of the nano-object, dust generation potential of processes, and actual exposure measurement data);
- Definition of recommended work environments and handling practices (control banding);
- Evaluation of the control strategy or risk banding.
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
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- ISO/TS 12901-2:2014; Nanotechnologies-Occupational Risk Management Applied to Engineered Nanomaterials-Part 2: Use of the Control Banding Approach. ISO. International Organization for Standardization: Geneva, Switzerland, 2014. Available online: https://www.iso.org/standard/53375.html (accessed on 15 December 2021).
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Ramos, D.; Almeida, L. Overview of Standards Related to the Occupational Risk and Safety of Nanotechnologies. Standards 2022, 2, 83-89. https://doi.org/10.3390/standards2010007
Ramos D, Almeida L. Overview of Standards Related to the Occupational Risk and Safety of Nanotechnologies. Standards. 2022; 2(1):83-89. https://doi.org/10.3390/standards2010007Chicago/Turabian Style
Ramos, Delfina, and Luis Almeida. 2022. "Overview of Standards Related to the Occupational Risk and Safety of Nanotechnologies" Standards 2, no. 1: 83-89. https://doi.org/10.3390/standards2010007