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 EN IEC 80001-1:2021
Publication date:
Jan 20, 2022
General information
60.60Standard publishedOct 29, 2021
CENELEC
CLC/TC 62
Electrical equipment in medical practice
European Norm
11.040.01
Medical equipment in general
| 35.240.80
IT applications in health care technology
Buying
Published
Scope
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.