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ISO/DIS 10993-3

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Note: Latest version: ISO 10993-3:2014

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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.

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Standard from ISO
Period for objection until: June 13 2025
Edition: 4
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.100.20
International TC: ISO/TC 194

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Revises: ISO 10993-3:2014

ISO/DIS 10993-3

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ISO 10993-3:2014

ISO 10993-3:2003

ISO 10993-3:1992

Abstract

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Version history History (3)

ISO 10993-3:2014

ISO 10993-3:2003

ISO 10993-3:1992

Abstract

Products specifications

Product Relations

Product life cycle