The biological evaluation of medical devices is conducted according to the ISO 10993 series of standards, which applies to the evaluation of materials and medical devices intended for direct or indirect contact with the body of a patient.
The ISO 10993 standard "Biological Evaluation of Medical Devices" consists of the following parts:
- ISO 10993-1: Evaluation and testing within a risk management process
- ISO 10993-2: Animal welfare requirements
- ISO 10993-3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-4: Selection of tests for interactions with blood
- ISO 10993-5: Tests for in vitro cytotoxicity
- ISO 10993-6: Tests for local effects after implantation
- ISO 10993-7: Ethylene oxide sterilization residuals
- ISO 10993-8: Selection and qualification of reference materials for biological tests
- ISO 10993-9: Framework for identification and quantification of potential degradation products
- ISO 10993-10: Tests for skin sensitization
- ISO 10993-11: Tests for systemic toxicity
- ISO 10993- 12: Sample preparation and reference materials
- ISO 10993-13: Identification and quantification of degradation products from polymeric medical devices
- ISO 10993-14: Identification and quantification of degradation products from ceramics
- ISO 10993-15: Identification and quantification of degradation products from metals and alloys
- ISO 10993-16: Toxicokinetic study design for degradation products and leachables
- ISO 10993-17: Establishment of allowable limits for leachable substances
- ISO 10993-18: Chemical characterization of medical device materials within a risk management process
- ISO 10993-22: Guidance on nanomaterials
- ISO 10993-23: Tests for irritation