Standard

NS-EN ISO 10993-3:2014

Jan 2015 Published

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Language English

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Abstract

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

Document information

Standard from SN
Published: 1 January 2015
Edition: 2014-10
Version: 1
Document type: NAT
ISBN:

ICS 11.100.20
National Committee SN/K 115

Legal references

EU law: 93/42/EEC, 90/385/EEC, 2007/47/EC

Product Relations

Replaces: NS-EN ISO 10993-3:2009
Referred by: NS-EN ISO 10993-7:2008
Adopted from: EN ISO 10993-3:2014 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 10993-3:2009
Current product

Published

NS-EN ISO 10993-3:2014

NS-EN ISO 10993-3:2014

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