(Superseding IS 11661 : 1986)

Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (Part 2-12) which is identical with ISO 80601-2-12 : 2011 ‘Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators’ issued by the International Organization for Standardization (ISO) 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 Electrical Equipment and Hospital Planning Division Council.

This standard applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as Medical Equipment.

This standard supersedes IS 11661 : 1986 ‘Specification for safety of lung ventilator for medical use’. After publication of this standard IS 11661 : 1986 shall be treated as withdrawn.

This standard is to be read in conjunction with IS 13450 (Part 1) ‘Medical electrical equipment: Part 1 General requirements for basic safety and essential performance (second revision) (Under publication), which is identical with IEC 60601-1 : 2012 (Edition 3.1).

The text of ISO 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.