Medical electrical equipment - Part 2-72: Particular requirement or basic safety and essential performance of home healthcare environment ventilators for ventilator dependent patients

201.1.1 *Scope 

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 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. 

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. 

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this part of ISO 80601 are not covered by specific requirements in this part of ISO 80601 except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. 

NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2. 

This part of ISO 80601 is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT, high-frequency jet ventilators (HFJVs), and high-frequency oscillatory ventilators (HFOVs)[35]. 

This part of ISO 80601 does not specify the requirements for cuirass and iron-lung VENTILATORS. 

This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for critical care applications, which are given in ISO 80601-2-12. 

This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for 2 © ISO 2015 - All rights reserved anaesthetic applications, which are given in ISO 80601-2-13. 

This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for emergency and transport which are given in ISO 10651-3. 

NOTE 5 In the future, ISO 10651-3 is expected to be harmonized with IEC 60601-1:2005, at which time it will be replaced by ISO 80601-2-xx. 

This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for home-care ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing PATIENTS), which are given in ISO 10651-6. 

NOTE 6 In the future, ISO 10651-6 is expected to be harmonized with IEC 60601-1:2005 and IEC 60601-1-11:2015, at which time it will be replaced by ISO 80601-2-xx. 

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 a particular International Standard in the IEC 60601-1 and ISO/IEC 80601 series of standards. 

201.1.2 Object 

IEC 60601-1:2005+AMD1:2012, 1.2 is replaced by: 

The object of this part of ISO 80601 is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for a VENTILATOR, as defined in 201.3.217, and its ACCESSORIES. 

NOTE ACCESSORIES are included because the combination of the VENTILATOR and the ACCESSORIES needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of a VENTILATOR.