IS 17922 : Part 1 : 2023/IEC 62366-1 : 2015 + AMD 1 : 2020 Medical Devices - Part 1 Application of Usability Engineering

ICS 11.040.01

MHD 14

NATIONAL FOREWORD

This Indian Standard (Part 1) (First Revision) which is identical to IEC 62366-1 : 2015 + AMD1 : 2020 CSV 'Medical devices - Part 1: Application of usability engineering to medical devices' issued by the International Electrotechnical Commission (IEC) was adopted by the Bureau of Indian Standards on recommendation of the Hospital Planning Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published in 2015 as IS/IEC 62366-1 : 2015, as an identical adoption of IEC 62366-1 : 2015 'Medical devices - Part 1: Application of usability engineering to medical devices'. This first revision has been undertaken to align it with the latest version of IEC 62366-1 and is the consolidated version of IEC 62366-1: 2015 which is inclusive of the following technical corrigendum and the amendment issued by the International Electrotechnical Commission.

 a) IEC 62366-1 : 2015/Cor 1 : 2016, and

 b) IEC 62366-1 : 2015/Amd 1 : 2020

The text of IEC standard has been approved as suitable for publication as an Indian Standard without deviations. Certain terminologies and conventions and terminologies are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following:

 a) Wherever the words 'International Standard' appear referring to this standard, they should be read as 'Indian Standard'; and

 b) Comma (,) has been used as a decimal marker, while in Indian Standards, the current practice is to use a point (.) as the decimal marker.