IEC 80001-1 Ed. 2.0 b PDF

IEC 80001-1 Ed. 2.0 b – 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

IEC 80001-1:2021 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.
 IEC 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.