CAN/CSA C22.2 NO. 80601-2-69:23 PDF

CSA Preface 

This is the second edition of CSA C22.2 No. 80601-2-69, Medical electrical equipment — Part 2-69: Particular requirements for the 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 (second edition, 2020-11). It supersedes the previous edition, published in 2016 as CSA C22.2 No. 80601-2-69 (adopted IEC 80601-2-69:2014). 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 "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 Standard 60601-1:2005, edition 3.2, 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 and Well-being. 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+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows: NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020. 

201.1.1 Scope 

IEC 60601-1:2005+AMD1:2012, 1.1 is replaced by: This document 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 by a single patient in various environments including any private and public transportation as well as in commercial aircraft. 

NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities. This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document 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 function or humidifier function. 

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[2]. 

EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function. This document 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. 

NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment. This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system. 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 7.2.13 and 8.4.1 of the general standard. 

NOTE 3 See also 4.2 of the general standard. 

201.1.2 Object 

IEC 60601-1:2005, 1.2 is replaced by: The object of this document is to establish particular basic safety and essential performance requirements for an oxygen concentrator (as defined in 201.3.202) and its accessories. 

NOTE 1 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. 

NOTE 2 This document has been prepared to address the relevant essential principles[8] and labelling[9] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex BB. 

NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex CC. 

NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 [7] as indicated in Annex DD.