Norm

IEC 62366:2007+A1:2014 en

Medische apparatuur - Aanbrengen van bruikbaarheid-engineering aan medische apparatuur

  • Deze norm is ingetrokken sinds 08-06-2016

357,29

Over deze norm

Status Ingetrokken
Aantal pagina's 209
Commissie Medische elektrische toestellen
Gepubliceerd op 01-01-2014
Taal Engels
IEC 62366:2007+A1 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, 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 and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a MEDICAL DEVICE.

Details

ICS-code 11.040
11.040.01
Nederlandse titel Medische apparatuur - Aanbrengen van bruikbaarheid-engineering aan medische apparatuur
Engelse titel Medical devices - Application of usability engineering to medical devices
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