Standard

NS-EN ISO 10993-3:2026

Sept 2026 Published

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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.

Document information

Standard from SN
Published: 21 September 2026
Edition: 2026-09
Version: 1
Document type: NAT
ISBN:

ICS 11.100.20
National Committee SN/K 115

Product Relations

Replaces: NS-EN ISO 10993-3:2014
Referred by: NS-EN 455-3:2006
Referred by: SN-CEN/TS 15277:2006
Adopted from: EN ISO 10993-3:2026

Product life cycle

Previous product

Withdrawn

NS-EN ISO 10993-3:2014
Current product

Published

NS-EN ISO 10993-3:2026

NS-EN ISO 10993-3:2026

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