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Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)
60.60 Standard published
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
60.60 Standard published
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/Amd 1:2025)
60.60 Standard published
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
60.60 Standard published
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
60.60 Standard published
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/Amd 1:2025)
60.60 Standard published
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
60.60 Standard published
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)
60.60 Standard published
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
60.60 Standard published
Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/Amd 1:2025)
60.60 Standard published
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
60.60 Standard published
Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity (ISO 10993-3:2026)
60.60 Standard published
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04)
60.60 Standard published
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
60.60 Standard published
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
60.60 Standard published
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
60.60 Standard published
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2026)
60.60 Standard published
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2026)
60.60 Standard published
