UNE-EN ISO 10993-3:2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Genotoxicity tests
  4.1 General
  4.2 Test strategy
  4.3 Sample preparation
  4.4 Test methods
      4.4.1 In vitro genotoxicity tests
      4.4.2 In vivo genotoxicity tests
5 Carcinogenicity tests
  5.1 General
  5.2 Test strategy
  5.3 Sample preparation
  5.4 Test methods
6 Reproductive and developmental toxicity tests
  6.1 General
  6.2 Test strategy
  6.3 Sample preparation
  6.4 Test methods
7 Test report
Annex A (informative) Cell transformation test system
Annex B (informative) Rationale of test systems
Annex C (informative) Role of implantation
        carcinogenicity studies
Bibliography

Gives strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity. Applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. Also provides guidance on selection of tests.