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Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
90.92 Standard to be revised
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
60.60 Standard published
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
90.60 Close of review
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
60.60 Standard published
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
90.93 Standard confirmed
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
90.93 Standard confirmed
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
60.60 Standard published
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
90.93 Standard confirmed
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
90.92 Standard to be revised
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
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
60.60 Standard published
Biological evaluation of medical devices — Part 2: Animal welfare requirements
60.60 Standard published
Biological evaluation of medical devices — Part 23: Tests for irritation
60.60 Standard published
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
90.92 Standard to be revised
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
90.60 Close of review
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
90.93 Standard confirmed
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
90.92 Standard to be revised
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
90.92 Standard to be revised