Standard

IEC 80001-1:2021

Sep 2021 Current

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Language English/French

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Abstract

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.

Products specifications

Standard from IEC
Published: September 22 2021
Edition: 2
Document type: IS
Pages
ISBN:

Publisher: IEC
Distributor: IEC
ICS: 11.040.01
ICS: 35.240.80
International TC: ISO/TC 215

Product Relations

Revises: IEC 80001-1:2010
Joinded work item: IEC/SC 62A, 0

IEC 80001-1:2021

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IEC 80001-1:2021

IEC 80001-1:2010

Abstract

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IEC 80001-1:2021

IEC 80001-1:2010

Abstract

Products specifications

Product Relations

Product life cycle