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ISO DIS 80601-2-72

2013 Edition, August 23, 2013

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MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS



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Superseded By: ISO 80601-2-72

Additional Comments:
NOW A PUBLISHED STD * SEE ISO 80601-2-72
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Description / Abstract:

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

This particular standard 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 are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM.

NOTE 2 Such VENTILATORS can also be used for PATIENTS who are not dependent on ventilatory support.

NOTE 3 In the HOME HEALTHCARE ENVIRONMENT, the driving power is often not reliable.

NOTE 4 Such VENTILATORS can also be used in professional health care facilities.

This particular standard 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, 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 standard are not covered by specific requirements in this standard except in IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1.

NOTE 5 Additional information can be found in IEC 60601-1:2005+A1:2012, 4.2.

This particular standard is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT, sleep apnoea therapy ME EQUIPMENT, critical care VENTILATORS, ventilatory support ME EQUIPMENT, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs).[33]

This particular standard does not specify the requirements for cuirass and "iron-lung" VENTILATORS.

This particular standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for critical care applications 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 ISO 80601-2-13.

This particular standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for emergency and transport which are given in ISO 10651-31).

This particular standard 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 10651-62).

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

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

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