Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

IEC 60601-1:2005+A1:2012, Clause 1 applies, except as follows:

201.1.1 * Scope

IEC 60601-1:2005+A1:2012, 1.1 is replaced by:

This particular standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SLEEP APNOEA BREATHING THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT, intended to alleviate the symptoms of PATIENTS who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the PATIENT. SLEEP APNOEA BREATHING THERAPY EQUIPMENT is intended for use in the HOME HEALTHCARE ENVIRONMENT by LAY OPERATORS as well as in professional healthcare institutions.

This particular standard excludes SLEEP APNOEA BREATHING THERAPY EQUIPMENT intended for use with neonates.

This particular standard is applicable to ME EQUIPMENT or an ME SYSTEM intended for those PATIENTS who are not dependent on mechanical ventilation.

This particular standard is not applicable to ME EQUIPMENT or an ME SYSTEM intended for those PATIENTS who are dependent on mechanical ventilation such as PATIENTS with central sleep apnoea.

This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to SLEEP APNOEA BREATHING THERAPY EQUIPMENT, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the SLEEP APNOEA BREATHING THERAPY EQUIPMENT.

MASKS and application ACCESSORIES intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. 3) Refer to Figure AA.1 for items covered further under this standard.

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 7.2.13 and 8.4.1 of the general standard.

NOTE 4 See also 4.2 of the General Standard.

This particular standard is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs).[16]

This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for critical care ventilators for ventilator-dependent PATIENTS which are given in ISO 80601-2-12.

This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for anaesthetic applications which are given in IEC 80601-2-13.

This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for home care ventilators for ventilator-dependent PATIENTS which are given in ISO 10651-24).

This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for emergency and transport which are given in ISO 10651-35).

This particular standard does not specify the requirements for ventilators or ACCESSORIES intended for homecare ventilatory support devices which are given in ISO 10651-66).

This particular standard is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

201.1.2 Object

IEC 60601-1:2005, 1.2 is replaced by:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for SLEEP APNOEA BREATHING THERAPY EQUIPMENT [as defined in 201.3.212].