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Exposure

Nanomaterial exposure standards are published by ISO. Because of their small size, many nanomaterials pose health risks to those who work with them regularly. The listed documents cover a variety of aspects related to exposure safety including exposure limits, toxicological screenings, physio-chemical characterization, and more. Laboratory management is obligated to protect laboratory workers’ health, and these documents can protect the investment of personnel to ensure those working with nanomaterials can be safe.

ISO/TR 18637:2016

Nanotechnologies - Overview of available frameworks for the development of occupational exposure limits and bands for nano-objects and their aggregates and agglomerates (NOAAs)

ISO/TR 16837:2016 provides an overview of available methods and procedures for the development of occupational exposure limits (OELs) and occupational exposure bands (OEBs) for manufactured nano-objects and their aggregates and agglomerates (NOAAs) for use in occupational health risk management decision-making.

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ISO/TS 19337:2016

Nanotechnologies - Characteristics of working suspensions of nano-objects for in vitro assays to evaluate inherent nano-object toxicity

ISO/TS 19337:2016 describes characteristics of working suspensions of nano-objects to be considered when conducting in vitro assays to evaluate inherent nano-object toxicity. In addition, this Technical Specification identifies applicable measurement methods for these characteristics. This Technical Specification is applicable to nano-objects, and their aggregates and agglomerates greater than 100 nm. NOTE This Technical Specification intends to help clarify whether observed toxic effects come from tested nano-objects themselves or from other uncontrolled sources.

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ISO/TR 16196:2016

Nanotechnologies - Compilation and description of sample preparation and dosing methods for engineered and manufactured nanomaterials

ISO/TR 16196:2016 provides guidance regarding the preparation of nanomaterials for eco- and bio- toxicological testing. It provides guidance regarding factors pertaining to sample preparation and dose determination that might be useful in toxicological, including ecotoxicological, testing of engineered and manufactured nanoscale materials. The descriptions of sample preparation method factors for both in vitro and in vivo toxicological testing of engineered and manufactured nanoscale materials include considerations about physico-chemical properties, media, methods for transformation and accumulation studies, health effects and dosimetry. The document is not intended to be a literature review nor a thorough assessment of the quality of the methods or data generated. The document is intended to complement other international efforts. The focus of this document is on factors that might lead to results that are not relevant to safety evaluations. When featured, referenced methods are considered for their general interest and potential applicability. It is likely that most of the described methods are not generally applicable to all nanomaterials but they do demonstrate important factors and limitations that are common for a variety of nanomaterials.

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ISO/TR 16197:2014

Nanotechnologies - Compilation and description of toxicological screening methods for manufactured nanomaterials

ISO/TR 16197:2014 provides a compilation and description of in vitro and in vivo methods that can be useful for the toxicological, including ecotoxicological screening of engineered and manufactured nanomaterials. Toxicological screening tests included in ISO/TR 16197:2014 can be used for such purposes as early decision-making in research and product development, rapid feedback on potential toxicological/safety concerns, or for the preliminary assessment of manufactured nanomaterials. ISO/TR 16197:2014 is divided between screening assays related to humans and screening assays related to the environment. A screening test is a relatively simple, inexpensive test that can be administered easily and provides an indication of potential adverse outcomes and effects on human health or the environment.

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ISO/TS 19006:2016

Nanotechnologies - 5-(and 6)-Chloromethyl-2,7 Dichloro-dihydrofluorescein diacetate (CM-H2DCF-DA) assay for evaluating nanoparticle-induced intracellular reactive oxygen species (ROS) production in RAW 264.7 macrophage cell line

ISO/TS 19006:2016 describes how to test and evaluate results obtained from in vitro ROS generation in RAW 264.7 macrophage cells exposed to nano-objects, nanoparticles, their aggregates and agglomerates using the CM-H 2 DCFDA assay. The protocol in ISO/TS 19006:2016 is limited to use of a 24 well plate so if other plates were to be used, volumes would need to be adjusted and the protocol steps validated to ensure confidence in the test results.

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ISO/TR 13014:2012

Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment

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ISO/TR 13014/Cor1:2012

Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment - Corrigendum 1

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ISO 10801:2010

Nanotechnologies - Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method

ISO 10801:2010 gives requirements and recommendations for generating metal nanoparticles as aerosols suitable for inhalation toxicity testing by the evaporation/condensation method. Its application is limited to metals such as gold and silver which have been proven to generate nanoparticles suitable for inhalation toxicity testing using the technique specified.

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ISO 10808:2010

Nanotechnologies - Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing

ISO 10808:2010 specifies requirements for, and gives guidance on, the characterization of airborne nanoparticles in inhalation exposure chambers for the purpose of inhalation toxicity studies in terms of particle mass, size distribution, number concentration and composition.

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