Reaffirmed 2023

NATIONAL FOREWORD

This Indian Standard (Part 2/Sec 5) (First Revision) which is identical with IEC 60601-2-5 : 2009 ‘Medical electrical equipment — Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment’ 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 2009 by adopting IEC 60601-2-5 : 2005 and published in IS 13450 series. On revision of IEC 60601-2-5 : 2005 first revision has been taken up to align it with the latest IEC Standard.

In this particular standard, safety and performance requirements additional to those in the general standard are specified for ULTRASONIC PHYSIOTHERAPY EQUIPMENT. This particular standard takes into account IEC 61689. The requirements are followed by specifications for the relevant tests.

A rationale for the more important requirements, where appropriate, is given in Annex AA. It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper application of the particular standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However this annex does not form part of the requirements of this standard.

This standard also makes a reference to the BIS Certification Marking of the product. Details of which are given in National Annex A.

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’.

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.