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DSF/PREN IEC 80001-1

Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software – Part 1: Application of risk management

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Organization: DS
Status: active
Page Count: 42
ICS Code (IT applications in health care technology): 35.240.80
ICS Code (Medical equipment in general): 11.040.01

Document History

November 1, 2021
Application of risk management for IT-networks incorporating medical devices – Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE,...
DSF/PREN IEC 80001-1
Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software – Part 1: Application of risk management
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