Deutsches Institut fur Normung e. V.

Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
 N EN ISO 80601-2-72

Annotation

IEC 60601 1:2005+AMD1:2012, 1.1 is replaced by:

This part of ISO 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT:

— intended for use in the HOME HEALTHCARE ENVIRONMENT;

— intended for use by a LAY OPERATOR;

— intended for use with PATIENTS who are dependent on mechanical ventilation for their life support.

NOTE 1 Such VENTILATORS can also be used for PATIENTS who are not dependent on ventilatory support.

NOTE 2 In the HOME HEALTHCARE ENVIRONMENT, the power driving the VENTILATOR is often not reliable.

NOTE 3 Such VENTILATORS can also be used in non critical care applications of professional health care facilities.

This part of ISO 80601 does not specify the requirements for obstructive sleep apnoea therapy ME EQUIPMENT, which are given in ISO 80601 2 70.[16]

This part of ISO 80601 is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a VENTILATOR BREATHING SYSTEM or to a VENTILATOR where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR.

EXAMPLES Breathing tubes, connectors, water traps, expiratory valve, HUMIDIFIER, BREATHING SYSTEM FILTER, external electrical power source, and DISTRIBUTED ALARM SYSTEM.