Reaffirmed 2023

NATIONAL FOREWORD

This Indian Standard (Part 2/Sec 29) (First Revision) which is identical with IEC 60601-2-29 : 2008 ‘Medical electrical equipment — Part 2-29 : Particular requirements for the basic safety and essential performance of radiotherapy simulators’ issued by the International Electrotechnical Commission (IEC) was adopted by Bureau of Indian Standards on the recommendation of the Electromedical and 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 identical to IEC 60601-2-29 : 1999. The first revision of this standard has been undertaken to incorporate the modifications effected in the latest version of IEC 60601-2-29 : 2009.

Only the English language text has been retained while adopting it in this standard and as such the page numbers given here are not the same as in the IEC Publication.

This particular standard establishes requirements to be complied with by manufacturers in the design and construction of radiotherapy simulators; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists, for example a component failure, and where an interlock then operates to prevent continued operation of the medical electrical equipment.

This edition constitutes a technical revision, which brings this standard in line with IS 13450 (Part 1) : 2008/IEC 60601-1 (2005) ‘Medical electrical equipment : Part 1 General requirements for basic safety and essential performance (first revision)’ and its collateral standards. This standard is to be read in conjunction with IS 13450 (Part 1) : 2008.

The text of IEC Standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are however not identical to those used in the 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’.

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.