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DANSK DS/EN IEC 80001-1 [ Active ]

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

standard by Dansk Standard , 11/01/2021

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Full Description

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.

 

Product Details

Edition:
21
Published:
11/01/2021
Number of Pages:
44
File Size:
1 file , 2.2 MB
Product Code(s):
DS-041, DS-041
 

Document History

  1. DANSK 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

    • Historical Version

  2. DANSK DS/EN IEC 80001-1

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    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

    • Most Recent