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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
90.92 Standard to be revised
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
90.92 Standard to be revised
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
90.92 Standard to be revised
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
90.20 Standard under periodical review
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
90.92 Standard to be revised
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
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 18: Chemical characterization of medical device materials within a risk management process
60.60 Standard published
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
90.93 Standard confirmed
Biological evaluation of medical devices — Part 2: Animal welfare requirements
90.92 Standard to be revised
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
90.20 Standard under periodical review
Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
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 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
60.60 Standard published
