Preclinical Performance Tests: FDA defines non-clinical bench performance testing mainly composed of:
- Mechanical performance tests such as fatigue, wear, tensile strength, compression, and burst pressure
- Bench tests using ex vivo, in vitro, and in situ animal or human tissue
- Animal carcass or human cadaver testing
Preclinical Safety Tests: Biological evaluation of medical devices (ISO 10993, the most widely used standard for assessing the biocompatibility of medical devices)
- 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 10993-9: Framework for identification and quantification of potential degradation products
- ISO 10993–10: Tests for irritation and 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 materials
- ISO 10993–19: Physico-chemical, morphological and topographical characterization of materials
- ISO 10993–20: Principles and methods for immunotoxicology testing of medical devices
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