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BSI - PREN ISO 80601-2-70

Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apneoa breathing therapy equipment

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Organization: BSI
Publication Date: 1 March 2013
Status: active
Page Count: 60
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
scope:

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 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 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 also are addressed by ISO 17510. 3) Refer to Figure AA.1 for items covered 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 HOME HEALTHCARE ENVIRONMENT ventilators, ventilatory support ME EQUIPMENT, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs), critical care ventilators or high-frequency oscillatory ventilators (HFOVs).[15] This particular standard does not specify the requirements for ME EQUIPMENT that is intended solely to augment the ventilation o219 f spontaneously breathing PATIENTS.

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 home230 care ventilatory support devices which are given in ISO 10651-66) .

This particular standard is a particular standard in the 60601-1 series of standards.

3) To be published.

4) In the future, this standard is expected to be harmonized with the IEC 60601-1:2005 and IEC 60601-1-11:2010 at which time it will be replaced by ISO 80601-2-xx.

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

6) In the future, this standard is expected to be harmonized with the IEC 60601-1:2005 and IEC 60601-1-11:2010 at which time it will be replaced by ISO 80601-2-xx.

 

Document History

PREN ISO 80601-2-70
March 1, 2013
Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apneoa breathing therapy equipment
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...

References

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