Medical electrical equipment – Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
|Publication Date:||1 April 2018|
|ICS Code (Medical equipment):||11.040|
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LOW ENERGY IONIZED GAS HAEMOSTASIS EQUIPMENT hereafter referred to as ME EQUIPMENT.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.