ISO/FDIS 10993-3

This draft is in the approval phase.

Will replace ISO 10993-3:2014 | ISO/TR 10993-33:2015

Abstract

ISO 10993-3:2014 specifies strategies for risk estimation and selection of hazard identification tests, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:

genotoxicity;
carcinogenicity;
reproductive and developmental toxicity.

ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

General information

Status
: Under development

Stage
: Proof sent to secretariat or FDIS ballot initiated: 8 weeks [50.20]
Edition
: 4

Number of pages
: 44
Technical Committee :
ISO/TC 194

ICS :
11.100.20
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