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NA 027-07-12 AA
Biological evaluation of medical devices
NA 176-03-09 AA
Sterilization and processing of medical devices
prCEN ISO/TS 17664-3
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 3: Guidance on the designation of a reusable medical device to a quantitative cleaning classification
prEN ISO 7405
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024)
prEN ISO 10993-1
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024)
prEN ISO 10993-2 rev
Biological evaluation of medical devices - Part 2: Animal welfare requirements
prEN ISO 10993-3 rev
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
prEN ISO 10993-6
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024)
prEN ISO 10993-7
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024)
prEN ISO 10993-11 rev
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
