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

Current

Current

The latest, up-to-date edition.

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

£145.13
Excluding VAT

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.

DevelopmentNote
Supersedes CSA Z18779. (07/2017)
DocumentType
Standard
ISBN
978-1-4883-1125-3
Pages
68
PublisherName
Canadian Standards Association
Status
Current
Supersedes

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.

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
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
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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