Podrobnosti návrhu

Číslo:prEN ISO 80601-2-67
Zdroj:CEN
Komise:CEN/TC 215
Název komise:Respiratory and anaesthetic equipment
Návrh uveřejněn:31.07.2019
K připomínkám do:17.09.2019
Contact email:cermak(at)agentura-cas.cz
Anotace:

This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.

NOTE 1        Conserving equipment can also be used in professional health care facilities.

NOTE 2        Conserving equipment can be used with an oxygen concentrator.

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 only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas). 

NOTE 3        Conserving equipment conforming with this document can be incorporated with other devices that have their own standards, in which case the combination needs to conform with both standards.

EXAMPLES     Conserving equipment combined with a pressure regulator (ISO 10524 series), an oxygen concentrator[2] or liquid oxygen equipment[3].

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 4        Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

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

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