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 EN IEC 80001-1:2021

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

Buying

Published

Language in which you want to receive the document.

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

PUBLISHED
EN 80001-1:2011

NOW

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