CAN/CSA-C22.2 NO. 80601-2-67:17

201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT
        and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
        HAZARDS
201.11 Protection against excessive temperatures and other
        HAZARDS
201.12 Accuracy of controls and instruments and protection
        against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and
        ME SYSTEMS
201.101 Gas connections
201.102 Requirements for parts and ACCESSORIES
201.103 Oxygen pressure regulators
202 Medical electrical equipment - Part 1-2: General
        requirements for basic safety and essential
        performance - Collateral standard: Electromagnetic
        compatibility - Requirements and tests
208 Medical electrical equipment - Part 1-8: General
        requirements for basic safety and essential
        performance - Collateral Standard: General
        requirements, tests and guidance for alarm systems
        in medical electrical equipment and medical
        electrical systems
211 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
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Reference to the Essential
         Principles
Bibliography
Alphabetical index of defined terms used in this
 particular standard

Pertains 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.

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). 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.