CEN - CEN/TC 206

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The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.

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CEN/TC 206

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Biological and clinical evaluation of medical devices
 
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CEN/TC 206 Work programme

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EN ISO 10993-12:2021/prA1 (WI=00206102)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/DAM 1:2024)
Under Approval2023-11-012024-09-112025-05-122025-05-12
EN ISO 10993-17:2023/prA1 (WI=00206106)
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAmd 1:2024)
Under Approval2023-11-012024-10-232025-06-232025-06-23
EN ISO 10993-23:2021/prA1 (WI=00206105)
Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/DAmd1:2024)
Under Approval2023-11-012024-12-182025-08-182025-08-18
EN ISO 10993-4:2017/prA1 (WI=00206099)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAmd 1:2024)
Under Approval2023-04-192024-10-072025-01-132024-10-07
EN ISO 10993-5:2009/prA11 (WI=00206109)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Under Drafting2024-08-192024-08-192024-12-192026-05-27
prEN ISO 10993-1 (WI=00206092)
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024)
Under Approval2022-01-142024-09-162025-05-162025-05-16
prEN ISO 10993-11 rev (WI=00206098)
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Under Drafting2023-04-192023-04-192023-10-192025-05-27
prEN ISO 10993-13 rev (WI=00206112)
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Under Drafting2024-10-312024-10-312025-04-302026-12-09
prEN ISO 10993-14 rev (WI=00206113)
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
Under Drafting2024-10-312024-10-312025-04-302026-12-09
prEN ISO 10993-16 rev (WI=00206103)
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Under Drafting2023-11-012023-11-012024-05-022025-12-15
prEN ISO 10993-2 (WI=00206104)
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2024)
Under Enquiry2023-11-012024-11-142025-02-032025-10-03
prEN ISO 10993-3 rev (WI=00206101)
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Under Drafting2023-11-012023-11-012024-05-022025-12-15
prEN ISO 10993-4 rev (WI=00206111)
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
Under Drafting2024-10-312024-10-312025-04-302026-12-09
prEN ISO 10993-6 (WI=00206097)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024)
Under Approval2023-01-062024-08-132025-04-142025-04-14
prEN ISO 10993-7 (WI=00206093)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024)
Under Approval2022-03-222024-12-062025-03-142024-12-06
prEN ISO 14155 (WI=00206095)
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024)
Under Approval2022-12-122024-09-122025-05-122025-05-12
prEN ISO 18969 (WI=00206096)
Clinical evaluation of medical devices
Under Drafting2023-01-162023-01-162023-07-172025-02-26
prEN ISO 21762 (WI=00206100)
Medical devices utilizing human tissues and their derivatives -- Application of risk management
Under Drafting2023-10-122023-10-122024-04-122025-11-27
prEN ISO 22442-3 rev (WI=00206110)
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
Under Drafting2024-10-312024-10-312025-04-302026-12-09
prEN ISO 8250 (WI=00206114)
Cleanliness of medical devices - Process design and test methods
Under Drafting2024-11-282024-11-282025-05-282027-01-08
 

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