Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

Designation Number:
CSA C22.2 NO. 80601-2-69
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
ICS code(s):
11.040.10
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

IEC 60601-1:2005+Amendment 1:2012, Clause 1 applies, except as follows:

201.1.1 Scope

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

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 or humidifier.

EXAMPLE 2 An OXYGEN CONCENTRATOR used 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.

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.

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

201.1.2 Object

IEC 60601-1:2005, 1.2 is replaced by:

The object of this International Standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for an OXYGEN CONCENTRATOR [as defined in 201.3.203] and its ACCESSORIES.

NOTE ACCESSORIES are included because the combination of the OXYGEN CONCENTRATOR and the ACCESSORIES needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR.

Project need:

To maintain alignment with international requirements (new edition of adoption, new adopted standard, new amendment of an adopted standard, etc.) This proposed New Edition and New Standards are being developed at the request of Z290 and C234 Technical Committees. It will provide the industry with the latest requirements for the safety testing of medical devices covered by the standards in Annex A.

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.