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IEC 80001-1:2021

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

Edition date: 2021-09-21
In Force
Available languages: English, French
Summary: 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.

L'IEC 80001-1:2021 spécifie des exigences générales au profit des ORGANISATIONS pour l’application de la GESTION DES RISQUES avant, pendant et après la connexion d’un SYSTEME TI DE SANTE au sein d’une INFRASTRUCTURE TI DE SANTE. Il traite des PROPRIETES CLES de SECURITE, d’EFFICACITE et de SURETE tout en impliquant les intervenants concernés.
L'IEC 80001-1:2021 annule et remplace la première édition parue en 2010. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) modification de la structure pour mieux s’aligner sur l’ISO 31000;
b) établissement d’exigences en faveur d’une ORGANISATION dans l’application de la GESTION DES RISQUES;
c) communication de la valeur, de l’objectif et de la finalité de la GESTION DES RISQUES à travers des principes qui favorisent la préservation des PROPRIETES CLES lors de la mise en œuvre et de l’utilisation des LOGICIELS DE SANTE et/ou SYSTEMES TI DE SANTE connectés.
ICS: 35.240.80-IT applications in health care technology, 11.040.01-Medical equipment in general
CTN: TC 62/SC 62A - 1359

Standards Cancellations

Anula a IEC 80001-1:2010

Otras Relaciones

Acuerdo de Frankfurt FprEN IEC 80001-1:2021

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