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BS EN 60601-1:2006+A2:2021
Medical electrical equipment General requirements for basic safety and essential performance
Medical electrical equipment General requirements for basic safety and essential performance
Vydáno: 2021-11-02
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PD 6630:1998
Nomenclature system for medical devices for the purpose of regulatory data exchange. Rationale
Nomenclature system for medical devices for the purpose of regulatory data exchange. Rationale
Vydáno: 1998-09-15
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PD CEN ISO/TR 24971:2020 - TC
Tracked Changes. Medical devices. Guidance on the application of ISO 14971
Tracked Changes. Medical devices. Guidance on the application of ISO 14971
Vydáno: 2020-08-14
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PD ISO/PAS 18761:2013
Use and handling of medical devices covered by the scope of ISO/TC 84. Risk assessment on mucocutaneous blood exposure
Use and handling of medical devices covered by the scope of ISO/TC 84. Risk assessment on mucocutaneous blood exposure
Vydáno: 2013-02-28
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25/30500985 DC
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 8684:2024
Technology enabled care. Assessment of user needs and risks, system design, installation and maintenance. Code of practice
Technology enabled care. Assessment of user needs and risks, system design, installation and maintenance. Code of practice
Vydáno: 2024-09-26
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24/30467651 DC
BS EN ISO 15223-1. AMD 1. Medical devices. Symbols to be used with information to be supplied by the manufacturer Part 1. General requirements
BS EN ISO 15223-1. AMD 1. Medical devices. Symbols to be used with information to be supplied by the manufacturer Part 1. General requirements
Vydáno: 2024-05-23
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