Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by:

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

- intended to be attended by a professional OPERATOR for those PATIENTS who are dependent on mechanical ventilation; and

   NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM.

- intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility.

NOTE 2 A critical care VENTILATOR intended for use in transport within a professional healthcare facility is not considered an emergency and transport ventilator.

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

This International Standard is not applicable to ME EQUIPMENT or an ME SYSTEM operating in ventilation modes intended for patients who are not dependent on mechanical ventilation.

NOTE 3 A critical care VENTILATOR, when operating in such a mode, is not considered LIFE-SUPPORTING ME EQUIPMENT OR ME 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 standard are not covered by specific requirements in this standard except in IEC 60601-1:2005, 7.2.13 and 8.4.1.

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

This International Standard is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT, sleep apnoea therapy ME EQUIPMENT, HOME HEALTHCARE ENVIRONMENT VENTILATORS, ventilatory support ME EQUIPMENT, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs).[26] This International Standard does not specify the requirements for ME EQUIPMENT that is intended solely to augment the ventilation of spontaneously breathing PATIENTS within a professional healthcare facility.

This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for anaesthetic applications which are given in ISO 80601-2-13.

This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for home care ventilators for ventilator-dependent PATIENTS which are given in ISO 10651-2).

This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for emergency and transport which are given in ISO 10651-3).

This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for home-care ventilatory support devices which are given in ISO 10651-6).