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SRPS 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

Dec 31, 2021

General information

90.93     Feb 2, 2026

90.00    Feb 2, 2031

ISS

N062

European Norm

35.240.80     11.040.01  

English  

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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WITHDRAWN
SRPS EN 80001-1:2012

NOW

PUBLISHED
SRPS EN IEC 80001-1:2021
90.93 Standard confirmed
Feb 2, 2026

Related project

Adopted from EN IEC 80001-1:2021

Adopted from IEC 80001-1:2021 ED2 IDENTICAL