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IEC 62366-1

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

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Organization: IEC
Publication Date: 1 February 2015
Status: active
Page Count: 114
ICS Code (Medical equipment): 11.040
scope:

This part of IEC 62366 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.

NOTE 1 SAFETY is freedom from unacceptable RISK. Unacceptable RISK can arise from USE ERROR, which can lead to exposure to direct physical HAZARDS or loss or degradation of clinical functionality.

NOTE 2 Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICES is available in IEC 62366-22, which addresses not only SAFETY but also aspects of USABILITY not related to SAFETY.

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.

NOTE 3 Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.

2 IEC 62366-2, Medical devices - Part 2: Guidance on the application of usability engineering to medical devices (in preparation).

Document History

July 1, 2016
Medical devices - Part 1: Application of usability engineering to medical devices
A description is not available for this item.
IEC 62366-1
February 1, 2015
Medical devices - Part 1: Application of usability engineering to medical devices
This part of IEC 62366 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...

References

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