ISO/TR 16196:2016
Current
The latest, up-to-date edition.
Nanotechnologies Compilation and description of sample preparation and dosing methods for engineered and manufactured nanomaterials
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English
22-09-2016
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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 |
| ABNT ISO/TR 16196:2024 | 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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