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ISO 10993-3:2003

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

Standard Details

ISO 10993-3:2003 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity.

ISO 10993-3:2003 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.

Guidance on selection of tests is provided in ISO 10993-1.

General Information

Status : WITHDRAWN
Standard Type: Main
Document No: ISO 10993-3:2003
Document Year: 2003
Pages: 16
Edition: 2
  • Section Volume:
  • ISO/TC 194. Biological evaluation of medical devices
  • ICS:
  • 11.100.20 Biological evaluation of medical devices

Life Cycle

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WITHDRAWN
ISO 10993-3:2003
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