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 published on 1.4.2022
Designation standards: ČSN EN IEC 80001-1-ed.2
Classification mark: 364880
Catalog number: 514242
Publication date standards: 1.4.2022
The number of pages: 44
Approximate weight : 132 g (0.29 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
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