CSA C22.2 NO. 80601-2-69:16 (R2021)

CSA Preface This is the first edition of CAN/CSA-C22.2 No. 80601-2-69, Medical electrical equipment — Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-69 (first edition, 2014-07-15). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code. For brevity, this Standard will be referred to as \"CAN/CSA-C22.2 No. 80601-2-69\" throughout. This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations) and CAN/CSAC22.2 No. 60601-1-11:15, Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (adopted IEC 60601-1-11:2015, with Canadian deviations). This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Application of Electricity in Health Care, under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology & Systems. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope and object 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.