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Joint implants - Part 2: Tiered toolkit approach to evaluate the biological impact of wear particles from joint replacements and related devices

90.93 Standard confirmed

CEN/WS 087

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

60.60 Standard published

CEN/TC 206

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

CEN/TC 206

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/DAM 1:2024)

40.20 DIS ballot initiated: 12 weeks

CEN/TC 206

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

CEN/TC 206

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1

30.99 CD approved for registration as DIS

CEN/TC 206

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

CEN/TC 206

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 (ISO 10993-18:2020/Amd 1:2022)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

60.60 Standard published

CEN/TC 206