CEN - CEN/CLC/JTC 3

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CEN/CLC/JTC 3

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Quality management and corresponding general aspects for medical devices
 
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CEN/CLC/JTC 3 Work programme

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EN ISO 15223-1:2021/prA1 (WI=JT003073)
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for authorized representative and Modified EC REP symbol to not be country or region specific (ISO 15223 1:2021/DAM 1:2024)
Under Approval2022-12-202024-08-152025-04-152025-04-15
FprEN ISO 80369-20 (WI=JT003063)
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO/FDIS 80369‑20:2024)
Approved2021-03-092024-09-092024-11-122024-03-11
prCEN ISO/TS 24971-2 (WI=JT003075)
Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence
Under Drafting2024-05-022024-05-022024-11-04 
prEN ISO 18250-1 (WI=JT003068)
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods
Under Drafting2022-11-092022-11-092023-03-092024-08-17
prEN ISO 18250-3 (WI=JT003069)
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications
Under Drafting2022-11-092022-11-092023-03-092024-08-17
prEN ISO 18250-6 (WI=JT003070)
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications
Under Drafting2022-11-092022-11-092023-03-092024-08-17
prEN ISO 18250-7 (WI=JT003071)
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion
Under Drafting2022-11-092022-11-092023-03-092024-08-17
prEN ISO 18250-8 (WI=JT003072)
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications
Under Drafting2022-11-092022-11-092023-03-092024-08-17
prEN ISO 20417 rev (WI=JT003074)
Medical devices - Information to be supplied by the manufacturer
Under Drafting2023-12-192023-12-192024-06-192026-01-29
prEN ISO 80369-1 (WI=JT003064)
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO/DIS 80369-1:2023)
Under Approval2021-03-262024-03-222024-06-282024-03-22
prEN ISO 80369-6 (WI=JT003067)
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO/DIS 80369-6:2023)
Under Approval2022-08-102023-11-032024-07-032024-07-03
 

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