IS 13450 : Part 2 : Sec 55 : 2025 Medical Electrical Equipment - Part 2 Particular Requirements for Basic Safety and Essential Performance - Section 55 Respiratory Gas Monitors (ISO 80601-2-55 : 2018, MOD)
NATIONAL FOREWORD
This Indian Standard which is modified adoption of ISO 80601-2-55 : 2018 'Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Anaesthetic, Resuscitation and Allied Equipment Sectional Committee and after approval of the Medical Equipment and Hospital Planning Division Council.
Amendment 1 published in 2023 to ISO 80601-2-55 : 2018 is given at the end of this publication.
Other parts in IS 13450 series are adopted (Identical as well as modified adoptions) from IEC 60601 series and ISO 80601 series which pertain to Medical Electrical Equipment.
Part 1 General requirements for basic safety and essential performance
Part 2 Particular requirements for basic safety and essential performance
Sec 12 Critical care ventilators
Sec 13 Anaesthetic Workstation
Sec 70 Sleep apnoea breathing therapy equipment
Sec 79 Ventilatory support equipment for ventilatory impairment
Sec 80 Ventilatory support equipment for ventilatory insufficiency
Sec 84 Ventilators for emergency medical services environment
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'; and
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.