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ISO/TR 16196:2016

Current
Current

The latest, up-to-date edition.

Nanotechnologies Compilation and description of sample preparation and dosing methods for engineered and manufactured nanomaterials
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

09-22-2016

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.

DocumentType
Technical Report
Pages
18
PublisherName
International Organization for Standardization
Status
Current

Standards Relationship
NEN NPR ISO/TR 16196 : 2016 Identical

ISO/TR 10993-22:2017 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
PD ISO/TR 10993-22:2017 Biological evaluation of medical devices Guidance on nanomaterials

ISO/TR 13014:2012 Nanotechnologies Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment
ISO 29701:2010 Nanotechnologies Endotoxin test on nanomaterial samples for in vitro systems Limulus amebocyte lysate (LAL) test
ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO/TS 80004-1:2015 Nanotechnologies — Vocabulary — Part 1: Core terms
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO/TS 19337:2016 Nanotechnologies — Characteristics of working suspensions of nano-objects for in vitro assays to evaluate inherent nano-object toxicity
ISO/TS 80004-2:2015 Nanotechnologies — Vocabulary — Part 2: Nano-objects

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