This part of ISO 10993 specifies tests for the following biological aspects:
- carcinogenicity, and
- reproductive and developmental toxicity.
These are relevant in the biological evaluation of some categories of medical devices (see note 1). Guidance on selection of tests is provided in ISO 10993-1. Where the need for the evaluation of the potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified, they should be evaluated in accordance with this part of ISO 10993.
Most tests included in this part of the International Standard refer to the OECD guidelines for testing of chemicals. Reference to these tests is made by the term OECD guideline(s) followed by the appropriate test number(s).
At the time of testing, these tests are to be performed according to current OECD guidelines.
The term devices corresponds to the definition given in ISO 10993-1 and covers materials, as well as dental materials and devices. The definition is in accordance with the CEN standard document.