Back

EVS-EN 60601-1-6:2010

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

General information
Valid from 07.06.2010
Base Documents
IEC 60601-1-6:2010; EN 60601-1-6:2010
Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Standard history
Status
Date
Type
Name
Amendment
EN 60601-1-6:2010/prA2:2019
15.11.2019
Main + amendment
08.06.2015
Amendment
07.06.2010
Main
08.04.2010
Corrigendum
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE.
*
*
*
PDF
15.01 € incl tax
Paper
15.01 € incl tax
Price: 2.40 € incl tax
Standard monitoring
Customers who bought this item also bought
Amendment

EVS-EN 60601-1-6:2010/A1:2015

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Valid from 08.06.2015
Main

EVS-EN 62366-1:2015

Medical devices - Part 1: Application of usability engineering to medical devices
Valid from 07.05.2015
Main

EVS-EN 60601-1-2:2015

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Newest version Valid from 03.12.2015
Main

EVS-EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Withdrawn from 02.01.2020