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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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BS ISO 20069:2019
Guidance for assessment and evaluation of changes to drug delivery systems
Guidance for assessment and evaluation of changes to drug delivery systems
Vydáno: 2019-08-07
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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 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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