SSH 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: Sep 16, 2022

General information

Current stage: 60.60 Effective date: Sep 16, 2022

Next stage: 90.93

Originator: DPS

Owner: DPS/KT 6

Type: European Norm

ICS: 11.040.01 35.240.80

Languages: English

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Status: Published

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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.

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PUBLISHED
SSH EN 80001-1:2011

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PUBLISHED
SSH EN IEC 80001-1:2021
60.60 Standard published
Sep 16, 2022

SSH 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

General information

Buying

Scope

Life cycle

PREVIOUSLY

NOW

Related project

Adopted from EN IEC 80001-1:2021

Adopted from IEC 80001-1:2021