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 softwareIEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) structure changed to better align with ISO 31000; b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT; c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.
IEC 80001-1:2021 is a standard that focuses on risk management for IT networks that incorporate medical devices. It provides guidance […]
IEC 80001-1:2021 risk management for IT-networks incorporating medical devices Read More »
IEC 80001-1:2021 is a standard that addresses the risk management of IT networks that incorporate medical devices. Here’s an overview
IEC 80001-1:2021 risk management for IT-networks incorporating medical devices Read More »
