IS 13450 : Part 2 : Sec 45 : 2024 Medical Electrical Equipment - Part 2 Particular Requirements for Basic Safety and Essential Performance - Section 45 Mammographic X-Ray Equipment and Mammographic Stereotactic Devices (IEC 60601-2-45 : 2022, MOD)
NATIONAL FOREWORD
This Indian Standard (Part 2/Sec 45) (Second Revision) which is modified adoption of IEC 60601-2-45 : 2022 'Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices' 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 2007 and was identical with IEC 60601-2-45 : 2001 'Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices'. The first revision was published in 2016 which was identical with IEC 60601-2-45 : 2011. The second revision has been undertaken to align it with the latest version IEC 60601-2-45 : 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.