• CAN/CSA-C22.2 NO. 80601-2-67:17

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    Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (Adopted ISO 80601-2-67:2014, first edition, 2014-06-01, with Canadian deviations)

    Available format(s):  Hardcopy, PDF

    Language(s):  French, English

    Published date:  01-01-2017

    Publisher:  Canadian Standards Association

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes CSA Z18779. (07/2017)
    Document Type Standard
    Publisher Canadian Standards Association
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures Particular requirements
    CSA C22.2 No. 60601-1-11 : 2015 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
    EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
    C22.1-15 Canadian Electrical Code, Part I (23rd Edition), Safety Standard for Electrical Installations
    CFR 45(PTS1-199) : OCT 2017 PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE
    ISO 8359:1996 Oxygen concentrators for medical use Safety requirements
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 18777:2005 Transportable liquid oxygen systems for medical use — Particular requirements
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
    ISO 14159:2002 Safety of machinery — Hygiene requirements for the design of machinery
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    CSA C22.2 No. 60601.1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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