Reference number
ISO 10993-3:2014
ISO 10993-3:2014
© ISO 2025
International Standard
ISO 10993-3:2014
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Edition 3
2014-10
2014-10
ISO 10993-3:2014
55614
Published
(Edition 3, 2014)
This publication was last reviewed and confirmed in 2023.
Therefore this version remains current.
Expected to be replaced by ISO/DIS 10993-3 within the coming months.
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.
General information
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Status: PublishedPublication date: 2014-10Stage: International Standard to be revised [90.92]
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Edition: 3Number of pages: 34
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Technical Committee :ISO/TC 194ICS :11.100.20
- RSS updates
Next version under development
Draft
International StandardISO/DIS 10993-3
Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity
Reference number
ISO/DIS 10993-3
ISO/DIS 10993-3
Edition 1
© ISO 2025
Draft International Standard
ISO/DIS 10993-3
Biological evaluation of medical devices
Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity
Life cycle
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Previously
WithdrawnISO 10993-3:2003
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Now
-
Will be replaced by
Under developmentISO/DIS 10993-3
