About CEN
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.
CEN/CLC/JTC 3 |
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Quality management and corresponding general aspects for medical devices |
CEN/CLC/JTC 3 Published Standards
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Project reference, Title
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Publication date
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Sales Points
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CEN ISO/TR 20416:2020
(WI=JT003052) Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020) |
2020-08-19 |
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CEN ISO/TR 24971:2020
(WI=JT003055) Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020) |
2020-07-22 |
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EN 15986:2011
(WI=JT003028) Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
2011-03-02 |
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EN 80369-5:2016
(WI=24533) Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
2016-11-04 |
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EN 80369-5:2016/AC:2017-02
(WI=64555) Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
2017-02-24 |
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EN 80369-5:2016/AC:2021-06
(WI=74057) Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
2021-06-25 |
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EN ISO 13485:2016
(WI=JT003030) Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
2016-03-02 |
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EN ISO 13485:2016/A11:2021
(WI=JT003056) Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
2021-09-08 |
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EN ISO 13485:2016/AC:2018
(WI=JT003C08) Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
2018-03-28 |
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EN ISO 14971:2019
(WI=JT003046) Medical devices - Application of risk management to medical devices (ISO 14971:2019) |
2019-12-18 |
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EN ISO 14971:2019/A11:2021
(WI=JT003066) Medical devices - Application of risk management to medical devices (ISO 14971:2019) |
2021-12-08 |
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EN ISO 15223-1:2021
(WI=JT003054) Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021) |
2021-09-29 |
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EN ISO 20417:2021
(WI=JT003053) Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12) |
2021-05-05 |
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EN ISO 80369-1:2018
(WI=JT003041) Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018) |
2018-11-21 |
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EN ISO 80369-20:2024
(WI=JT003063) Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369‑20:2024) |
2024-11-27 |
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EN ISO 80369-2:2024
(WI=JT003061) Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2024-09) |
2024-08-28 |
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EN ISO 80369-3:2016
(WI=JT003035) Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) |
2016-08-10 |
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EN ISO 80369-3:2016/A1:2022
(WI=JT003059) Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019) |
2022-11-30 |
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EN ISO 80369-6:2016
(WI=JT003036) 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) |
2016-04-13 |
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EN ISO 80369-7:2021
(WI=JT003058) Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021) |
2021-05-19 |
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