IEC 80001-1:2021Published

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

Application de la gestion des risques aux réseaux des technologies de l’information contenant des dispositifs médicaux — Partie 1: Sûreté, efficacité et sécurité dans la mise en oeuvre et l'utilisation des dispositifs médicaux connectés ou des logiciels de santé connectés

A new edition is under development: ISO/CD 81001-4-1.

Abstract / scope

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.

Life cycle

Replaces

IEC 80001-1:2010WithdrawnApplication of risk management for IT-networks incorporating medical devices — Part 1: Roles, responsibilities and activitiesInternational Standard · Published 28 Oct 2010 · ISO/TC 215

Replaced by

ISO/CD 81001-4-1Under developmentHealth software and health IT systems safety, effectiveness and security — Part 4-1: Application of risk management in the implementation and clinical use phasesInternational Standard · ISO/TC 215