Projects

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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 23: Tests for irritation - Amendment 1

10.99 New project approved

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

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAmd 1:2024)

40.20 DIS ballot initiated: 12 weeks

CEN/TC 206

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

60.60 Standard published

CEN/TC 206

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

10.99 New project approved

CEN/TC 206

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

60.60 Standard published

CEN/TC 206

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

60.60 Standard published

CEN/TC 206

Clinical investigation of medical devices for human subjects - Good clinical practice

10.99 New project approved

CEN/TC 206

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

60.60 Standard published

CEN/TC 206

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

60.60 Standard published

CEN/TC 206

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)

60.60 Standard published

CEN/TC 206