Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
NOTE 1 Conserving equipment can also be used in professional health care facilities.
This document is also applicable to conserving equipment that is incorporated with other equipment.
EXAMPLE Conserving equipment combined with a pressure regulator, an oxygen concentrator or liquid oxygen equipment.
This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.
This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling.
This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).
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 document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
|Publication type||International Standard|
|Available language(s)||English, French|
|TC/SC||TC 62/SC 62D - Electromedical equipmentrss|
|ICS||11.040.10 - Anaesthetic, respiratory and reanimation equipment|
|File size||1670 KB|
The following test report forms are related:
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