SS-EN-ISO-10993-3 › Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

SS-EN-ISO-10993-3 - 2014 EDITION - CURRENT
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This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, 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.This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.NOTE Guidance on selection of tests is provided in ISO 10993-1.

To find similar documents by classification:

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)


Active implantable medical devices. Medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

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Designation Name

SS-EN ISO 10993-3:2014

Revision Level

2014 EDITION

Status

Current

Publication Date

Oct. 19, 2014

Language(s)

English

Page Count

52

International Equivalent

EN ISO 10993-3:2014(IDT); ISO 10993-3:2014(IDT)