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EVS-EN 62366:2008

Medical devices – Application of usability engineering to medical devices

General information

Withdrawn from 05.01.2016
Base Documents
IEC 62366:2007; EN 62366:2008
ICS Groups
11.040 Medical equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
08.06.2015
Amendment
EVS-EN 62366:2008/A1:2015
07.05.2015
Main
EVS-EN 62366-1:2015
07.03.2008
Main
EVS-EN 62366:2008
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.

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Standard monitoring
English (PDF 218 KB)

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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