IEC - 80001-1
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
|Publication Date:||1 September 2021|
|ICS Code (IT applications in health care technology):||35.240.80|
|ICS Code (Medical equipment in general):||11.040.01|
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.