CSA Preface
This is the first edition of CAN/CSA-C22.2 No. 80601-2-67, Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-67 (first edition, 2014-06-01). It replaces CAN/CSA-Z18779:08, Medical devices for conserving oxygen and oxygen mixtures — Particular requirements (adopted ISO 18779:2005). 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. 80601-2-67 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+A1:2012, Clause 1 applies, except as follows:
201.1.1 * Scope
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
This particular standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of oxygen CONSERVING EQUIPMENT, hereafter referred to as ME EQUIPMENT, in combination with its ACCESSORIES intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the PATIENT'S inspiratory cycle, when used in the HOME HEALTHCARE ENVIRONMENT. Oxygen CONSERVING EQUIPMENT is typically used by a LAY OPERATOR.
NOTE 1 CONSERVING EQUIPMENT can also be used in professional health care facilities.
NOTE 2 CONSERVING EQUIPMENT can be used with an oxygen concentrator.
This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to CONSERVING EQUIPMENT, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the CONSERVING EQUIPMENT.
This particular standard is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).
NOTE 3 CONSERVING EQUIPMENT complying with this particular standard can be incorporated with other devices that have their own standards, in which case the combination needs to comply with both standards.
EXAMPLES CONSERVING EQUIPMENT combined with a pressure regulator [2], an oxygen concentrator [1] or liquid oxygen equipment [6].
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 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 4 See also 4.2 of the general standard.
This particular standard is a particular standard in the IEC 60601 series of standards.
201.1.2 Object
IEC 60601-1:2005, 1.2 is replaced by:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for CONSERVING EQUIPMENT [as defined in 201.3.201] and its ACCESSORIES.
NOTE ACCESSORIES are included because ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of CONSERVING EQUIPMENT.
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