IEC 80001-1:2021 PRV 
Pre release version

Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management

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Abstract

This Final Draft International Standard is an up to 6 weeks' pre-release of the official publication. It is available for sale during its voting period: 2021-02-12 to 2021-03-26. By purchasing this FDIS now, you will automatically receive, in addition, the final publication.

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.

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Additional information

Publication typeInternational Standard
Publication date2021-02-12
Edition2.0
Available language(s)English
TC/SCTC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss
ICS11.040.01 - Medical equipment in general
35.240.80 - IT applications in health care technology
Stability date  2026
Pages39
File size1376 KB

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