CEN/CLC/TC 3
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
31995 | prEN ISO 14971 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) | Izstrādē |
32013 | prEN ISO 13485 rev | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) | Izstrādē |
28643 | prEN 15546-2 | Small bore connectors for liquids and gases in healthcare applications - Part 2 - Connectors for respiratory applications | Izstrādē |
80075 | prCEN ISO/TS 24971-2 | Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence | Izstrādē |
81836 | prCEN ISO/TS 23485 | Medical Devices -- Quality management systems -- Guideline for the application of ISO 13485:2016 | Izstrādē |
81349 | prCEN ISO/TR 20416 rev | Medical devices — Post-market surveillance for manufacturers | Izstrādē |
70256 | LVS EN ISO 80369-7:2021 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021) | Standarts spēkā |
39370 | LVS EN ISO 80369-7:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016) | Atcelts |
76512 | LVS EN ISO 80369-6:2025 | Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neural applications (ISO 80369-6:2025) | |
39366 | LVS EN ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15) | Standarts spēkā |
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