Skip to main content
Back

EVS-EN 80001-1:2011

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

General information

Withdrawn from 15.11.2021
Base Documents
IEC 80001-1:2010; EN 80001-1:2011
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.11.2021
Main
05.04.2011
Main
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKS incorporating MEDICAL DEVICES to address SAFETY, EFFECTIVENESS and DATA AND SYSTEM SECURITY (the KEY PROPERTIES). This international standard does not specify acceptable RISK levels.

Required fields are indicated with *

*
*
*
PDF
26.84 € incl tax
Paper
26.84 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 15223-1:2016

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
Withdrawn from 01.10.2021
Main + corrigendum

EVS-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 02.03.2016
Main + amendment

EVS-EN 62304:2006+A1:2015

Medical device software - Software life-cycle processes
Newest version Valid from 15.11.2019
Main

EVS-EN ISO/IEC 27001:2017

Information technology - Security techniques - Information security management systems - Requirements (ISO/IEC 27001:2013 including Cor 1:2014 and Cor 2:2015)
Withdrawn from 15.08.2023