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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
90.92 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 17: Toxicological risk assessment of medical device constituents — Amendment 1
20.00 New project registered in TC/SC work programme
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
90.92 Standard to be revised
Biological evaluation of medical devices — Part 23: Tests for irritation
60.60 Standard published
Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1
20.00 New project registered in TC/SC work programme
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
90.93 Standard confirmed
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
40.20 DIS ballot initiated: 12 weeks
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
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
60.60 Standard published
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1
60.60 Standard published
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
60.60 Standard published