SS IEC 62366-1 Amendment 1:2020

Amendment1 - Medical devices Part 1: Application of usability engineering to medical devices

OVERVIEW

The first edition of IEC 62366-1 was published in 2015. Since its publication, experts working in the field have identified several inaccuracies that warrant correction. In total, 22 issues were identified and presented to the National Committee members of IEC/SC 62A and to the Member Bodies of ISO/TC 210. A majority of the members of both committees that stated a position supported developing this amendment to address the identified issues while making no fundamental changes to the USABILITY ENGINEERING PROCESS as originally conceived in IEC 62366-1:2015.

COMMENTS

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PRODUCT DETAILS

Status Current
Edition 2020
No. of Pages 18
ICS Classification 11.040 Medical equipment
Committee Biomedical and Health Standards Committee
Available for Purchase Global
Adoption IEC 62366-1:2015/AMD1:2020 : 2020 IDT