Standard

NEN-EN-IEC 62366-1:2015 en

Medical devices - Part 1: Application of usability engineering to medical devices

Fully inclusive:

281,15 306,45 Incl BTW

About norm

Status Current
Number of pages 110
Committee Medische elektrische toestellen
Published on 01-05-2015
Language English
NEN-EN-IEC 62366-1 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS 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. If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.

Details

ICS-code 11.040
Dutch title Medische apparatuur - Deel 1: Aanbrengen van bruikbaarheid-engineering aan medische apparatuur
English title Medical devices - Part 1: Application of usability engineering to medical devices
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