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ANSI/AAMI/ISO 10993-3:2014(R2023)

Current

Current

The latest, up-to-date edition.

Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-10-2023

€246.76
Excluding VAT

This part of ISO 10993 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.

Committee
ISO/TC 194
DocumentType
Standard
Pages
50
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
ISO 10993-3:2014 Identical

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