IS 13450 : Part 1 : 2024 Medical Electrical Equipment - Part 1 General Requirements for Basic Safety and Essential Performance (IEC 60601-1 : 2020, MOD)
NATIONAL FOREWORD
This Indian Standard (Part 1) (Third Revision) which is modified adoption of IEC 60601-1 : 2020 'Medical electrical equipment - Part 1 : General requirements for the basic safety and essential performance' 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This Indian Standard was first published as IS 8607 (Parts 1 to 8) which was subsequently withdrawn and replaced by IS 13450 (Part 1) : 1994. It was first revised in 2008 by adopting IEC 60601-1 : 2005 (Edition 3.0). The second revision was published in 2018 which was an identical adoption of the consolidated version IEC 60601-1 : 2012 that is, IEC 60601-1 : 2005 + AMD 1 : 2012 (Edition 3.1). The third revision has been undertaken to align it with the latest consolidated version IEC 60601-1 : 2020 that is, IEC 60601-1 : 2005 + AMD 1 : 2012 + AMD 2 : 2020 (Edition 3.2).
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.