IS 13450 : Part 2 : Sec 43 : 2024 Medical Electrical Equipment - Part 2 Particular Requirements for Basic Safety and Essential Performance - Section 43 X-ray Equipment for Interventional Procedures (IEC 60601-2-43 : 2022, MOD)

ICS 11.040.60

MHD15

NATIONAL FOREWORD

This Indian Standard (Part 2/Sec 43) (Second Revision) which is modified adoption of IEC 60601-2-43 : 2022 'Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures' issued by the International Electrotechnical Commission (IEC) was adopted by the Bureau of Indian Standards on the recommendation of the Electromedical, Diagnostic Imaging and Radiotherapy Equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published in 2008 and was identical to IEC 60601-2-43 : 2000 'Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures'. The first revision was published in 2016 which was identical to IEC 60601-2-43 : 2010. The second revision has been undertaken to align it with the latest version IEC 60601-2-43 : 2022.

The text of IEC standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions 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.