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prSRPS EN ISO 10993-3:2024

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

General information

10.99    

ISS

Z076

European Norm

English  

Scope

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.

Related directives

Directives related to this standard.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN ISO 10993-3:2017

NOW

PROJECT
prSRPS EN ISO 10993-3:2024
10.99 New project approved

Related project

Adopted from prEN ISO 10993-3 rev IDENTICAL

Adopted from ISO/CD 10993-3 IDENTICAL