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EN 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

Publication date:   Jan 20, 2022

General information

60.60 Standard published   Oct 29, 2021

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040.01   Medical equipment in general | 35.240.80   IT applications in health care technology

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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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN 80001-1:2011

NOW

PUBLISHED
EN IEC 80001-1:2021
60.60 Standard published
Oct 29, 2021