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PD IEC/TR 80001-2-5:2014
Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on distributed alarm systems
Application of risk management for IT-networks incorporating medical devices Application guidance. Guidance on distributed alarm systems
Vydáno: 2014-12-16
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PD IEC/TR 80002-1:2009
Medical device software Guidance on the application of ISO 14971 to medical device software
Medical device software Guidance on the application of ISO 14971 to medical device software
Vydáno: 2009-09-23
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PD IEC/TR 80002-3:2014
Medical device software Process reference model of medical device software life cycle processes (IEC 62304)
Medical device software Process reference model of medical device software life cycle processes (IEC 62304)
Vydáno: 2014-06-04
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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 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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PD ISO/TR 19244:2014
Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters
Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters
Vydáno: 2014-08-31
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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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402.99 €
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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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