Hello. Sign In
Standards Store
Look Inside

AAMI 62366-1

2015 Edition, January 1, 2015

Complete Document

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

Detail Summary

Active, Most Current

Additional Comments:
SAME AS IEC 62366-1
Price (USD)
In Stock
Add to Cart

People Also Bought These:

BS EN ISO 13485
BS EN ISO 15223-1
ASME Y14.5

Product Details:

Description / Abstract:

This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyze, 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.