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EVS-EN 60601-1-6:2007

Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

General information

Withdrawn from 07.06.2010
Base Documents
IEC 60601-1-6:2006; EN 60601-1-6:2007
ICS Groups
11.040 Medical equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
07.06.2010
Main
EVS-EN 60601-1-6:2010
08.04.2010
Corrigendum
EVS-EN 60601-1-6:2007/AC:2010
Main
EVS-EN 60601-1-6:2007
Main
EVS-EN 60601-1-6:2004
This International Standard specifies requirements for a PROCESS to analyse, design, verify and validate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This collateral standard addresses NORMAL USE and USE ERRORS but excludes ABNORMAL USE.

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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