Standard

ISO/DIS 10993-3

Draft

Note: This standard has a new edition: 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.

Document information

Standard from ISO
Expires: 13 June 2025
Edition: 4
Version: 1
Document type: IS
Pages
ISBN:

ICS 11.100.20
ISO TC ISO/TC 194

Product Relations

Revises: ISO 10993-3:2014
Revises: ISO 10993-3:2014
Revises: ISO 10993-3:2014

ISO/DIS 10993-3

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ISO 10993-3:2014

ISO 10993-3:2014

ISO 10993-3:2014

ISO 10993-3:2003

ISO 10993-3:2003

ISO 10993-3:1992

Abstract

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Product Relations

Product life cycle

Access to standards for the entire organization

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Extended editions Extended editions (0)

Version history Related corrigendum and amendments (0)

Version history History (6)

ISO 10993-3:2014

ISO 10993-3:2014

ISO 10993-3:2014

ISO 10993-3:2003

ISO 10993-3:2003

ISO 10993-3:1992

Abstract

Document information

Product Relations

Product life cycle