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BS EN ISO 13485:2016+A11:2021
Medical devices. Quality management systems. Requirements for regulatory purposes
Medical devices. Quality management systems. Requirements for regulatory purposes
Vydáno: 2021-09-08
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BS EN ISO 14971:2019+A11:2021
Medical devices. Application of risk management to medical devices
Medical devices. Application of risk management to medical devices
Vydáno: 2021-12-15
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PD ISO/TR 80002-2:2017
Medical device software Validation of software for medical device quality systems
Medical device software Validation of software for medical device quality systems
Vydáno: 2017-10-31
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PD ISO/TR 80001-2-6:2014
Application of risk management for IT-networks incorporating medical device Application guidance. Guidance for responsibility agreements
Application of risk management for IT-networks incorporating medical device Application guidance. Guidance for responsibility agreements
Vydáno: 2014-11-30
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PD IEC/TR 62296:2009
Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
Vydáno: 2009-01-22
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BS EN IEC 81001-5-1:2022
Health software and health IT systems safety, effectiveness and security Security. Activities in the product life cycle
Health software and health IT systems safety, effectiveness and security Security. Activities in the product life cycle
Vydáno: 2022-02-16
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