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Draft BS EN 63521 Machine Learning-enabled Medical Device. Performance Evaluation Process
Draft BS EN 63521 Machine Learning-enabled Medical Device. Performance Evaluation Process
Vydáno: 2025-05-09
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BS EN 62353:2014
Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
Vydáno: 2014-12-31
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PD ISO/IEC GUIDE 63:2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Vydáno: 2019-08-21
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PD CEN ISO/TR 20416:2020
Medical devices. Post-market surveillance for manufacturers
Medical devices. Post-market surveillance for manufacturers
Vydáno: 2020-08-19
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PD IEC/TR 62366-2:2016
Medical devices Guidance on the application of usability engineering to medical devices
Medical devices Guidance on the application of usability engineering to medical devices
Vydáno: 2016-04-27
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