ISO DIS 80601-2-69

Description / Abstract: This particular standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT, intended to increase the oxygen concentration in the gas intended to be delivered to a single PATIENT. Such OXYGEN CONCENTRATORS are typically intended for use in the HOME HEALTHCARE ENVIRONMENT, including TRANSIT-OPERABLE use by a single PATIENT in various environments including any private and public transportation and commercial aircraft.

NOTE 1 An OXYGEN CONCENTRATOR can also be used in professional healthcare facilities.

This particular standard is applicable to a TRANSIT-OPERABLE or non-TRANSIT-OPERABLE OXYGEN CONCENTRATOR. This particular standard is applicable to an OXYGEN CONCENTRATOR integrated into or used with other ME EQUIPMENT or ME SYSTEMS.

EXAMPLE 1 An OXYGEN CONCENTRATOR with integrated oxygen CONSERVING EQUIPMENT or humidifier.

EXAMPLE 2 An OXYGEN CONCENTRATOR used with a flowmeter stand.

This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to an OXYGEN CONCENTRATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the OXYGEN CONCENTRATOR.

This particular standard does not specify the requirements for OXYGEN CONCENTRATORS for use with a MEDICAL GAS PIPELINE SYSTEM which are given in ISO 10083.

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 2 See also 4.2 of the General Standard.

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