Norm

NEN-EN-IEC 62366-1:2015 en

Medische apparatuur - Deel 1: Aanbrengen van bruikbaarheid-engineering aan medische apparatuur

Volledig inclusief:

226,42

Over deze norm

Status Definitief
Aantal pagina's 110
Commissie Medische elektrische toestellen
Gepubliceerd op 01-05-2015
Taal Engels
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
Nederlandse titel Medische apparatuur - Deel 1: Aanbrengen van bruikbaarheid-engineering aan medische apparatuur
Engelse titel Medical devices - Part 1: Application of usability engineering to medical devices
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