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Biological testing of medical and dental materials and devices - Method(s) of test to evaluate systemic toxicity (ISO 10993-9)
20.60 Close of comment period
Biological evaluation of medical devices - Methods of testing for degradation products
10.99 New project approved
Biological evaluation of medical devices - Glutaraldehyde and formaldehyde residuals
10.99 New project approved
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
60.60 Standard published
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
60.60 Standard published
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
60.55 Ratification completed (DOR)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
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 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
60.60 Standard published
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
60.60 Standard published
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
60.60 Standard published
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
60.60 Standard published
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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