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SRPS EN ISO 10993-3:2017

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

Jan 31, 2017

General information

60.60     Jan 31, 2017

ISS

Z076

European Norm

11.100.20  

English  

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Scope

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.

Related directives

Directives related to this standard.

93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
90/385/EEC

Active implantable medical devices

Harmonized
Directive 90/385/EEC
2007/47/EC

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

Directive 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 10993-3:2011

NOW

PUBLISHED
SRPS EN ISO 10993-3:2017
60.60 Standard published
Jan 31, 2017

REVISED BY

ABANDON
delSRPS EN ISO 10993-3:2022

PROJECT
prSRPS EN ISO 10993-3:2024

Related project

Adopted from EN ISO 10993-3:2014

Adopted from ISO 10993-3:2014 IDENTICAL