DS/EN IEC 80001-1:2021
Current
Current
The latest, up-to-date edition.
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
Published date
05-11-2021
Publisher
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, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.
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