ISO 10993-3:2003 PDF
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Title (English):
ISO 10993-3:2003
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 16
- Publication date:
- October 22, 2003
- Edition:
- ISO IS 10993 edition 2 version 1
- ICS:
- 11.100.20
Description (English):
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.
Technical details
- Technical committee
- ISO/TC 194 - Biological and clinical evaluation of medical devices
- SKU
- ISO 10993-3:2003
