Standard

SN EN ISO 10993-3:2014

Dec 2014 Current

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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.

Products specifications

Standard from INB
Published: December 1 2014
Effective: December 1 2014
Document type: EN
Pages
ISBN:

ICS: 11.100.20
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 129

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law: 812.213
Designated under following EU law: 90/385/EWG, 93/42/EWG

Product Relations

Adopted from: ISO 10993-3:2014, IDT
Replaces: SN EN ISO 10993-3:2009

SN EN ISO 10993-3:2014

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