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Withdrawn from 15.11.2021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
ICS Groups
11.040.01 Medical equipment in general 35.240.80 IT applications in health care technology
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.11.2021
Main
EVS-EN IEC 80001-1:2021
05.04.2011
Main
EVS-EN 80001-1:2011
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
English (PDF 541 KB)

Related products

Main

EVS-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
Newest version Valid from 15.11.2021
Main + amendment

EVS-EN ISO 13485:2016+A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Newest version Valid from 16.09.2021
Main

EVS-EN ISO 15223-1:2021

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
Newest version Valid from 01.10.2021
Main + amendment

EVS-EN ISO 14971:2019+A11:2021

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Newest version Valid from 15.12.2021

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Withdrawn from 01.10.2021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

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English