IS 13450 : Part 2 : Sec 16 : 2019/IEC 60601-2-16 : 2018 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 16 Haemodialysis, haemodiafiltration and haemofiltration equipment

ICS 11.040.20; 11.040.25

MHD 15

New Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (Part 2/Sec 16) which is identical with IEC 60601-2-16 : 2018 ‘Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment’ issued by the International Electrotechnical Commission (IEC) was adopted by the Bureau of Indian Standards on recommendation of Electromedical, Diagnostic, Imaging and Radiotherapy Equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

The text of IEC Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain terminologies and 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.