IS 13450 : Part 1 : Sec 11 : 2024 Medical Electrical Equipment - Part 1 General Requirements for Basic Safety and Essential Performance - Section 11 Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment (IEC 60601-1-11 : 2020, MOD)
NATIONAL FOREWORD
This Indian Standard (Part 1/Sec 11) (First Revision) which is modified adoption of IEC 60601-1-11 : 2020 'Medical electrical equipment - Part 1-11: General requirements for the basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment' 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 2020 as an identical adoption of IEC 60601-1-11 : 2015 'Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment'. The first revision has been undertaken to align it with the latest consolidated version IEC 60601-1-11 : 2020 i.e. IEC 60601-1-11 : 2015 + AMD 1 : 2020 (Edition 2.1).
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.