CSA Standards

Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment - First Edition
 N CAN/CSA-C22.2 NO. 80601-2-69:16

Annotation

This particular standard specifies requirements for 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 of 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 as well as in commercial aircraft.

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

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

EXAMPLE 1 An OXYGEN CONCENTRATOR with integrated oxygen CONSERVING EQUIPMENT [10] OXYGEN CONCENTRATOR use or humidifier [4].

EXAMPLE 2 An d with a flowmeter stand.

EXAMPLE 3 An OXYGEN CONCENTRATOR as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases. [3]

EXAMPLE 4 An OXYGEN CONCENTRATOR with an integrated liquid reservoir or gas cylinder filling system.

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.