IS 13450 : Part 2 : Sec 18 : 2014/IEC 60601-2-18 : 2009 : Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 18 Endoscopic Equipment

NATIONAL FOREWORD

This Indian Standard (Part 2/Sec 18) which is identical with IEC 60601-2-18 : 2009 ‘Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment’ issued by the International Electrotechnical Commission (IEC) was adopted by the Bureau of Indian Standards on the recommendation of the Electromedical Equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

The minimum safety requirements specified in this standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment.

This standard is to be read in conjunction with IS 13450 (Part 1) : 2008 ‘Medical electrical equipment: Part 1 General requirements for basic safety and essential performance (first revision)’.

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 and terminologies 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