60.60 Standard published Sep 22, 2021
IEC
ISO/TC 215 Health informatics
International Standard
35.240.80 IT applications in health care technology | 11.040.01 Medical equipment in general
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. 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.
WITHDRAWN
IEC 80001-1:2010
PUBLISHED
IEC 80001-1:2021
60.60
Standard published
Sep 22, 2021