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CSA C22.2 No. 80601-2-69 : 2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT
Available format(s)

Hardcopy , PDF

Superseded date

09-25-2021

Language(s)

French, English

Published date

07-01-2016

Foreword
Introduction
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 Outlet connector
201.102 Requirements for parts and ACCESSORIES
201.103 SIGNAL INPUT/OUTPUT PART
201.104 Indication of duration of operation
201.105 Integrated CONSERVING EQUIPMENT
202 Medical electrical equipment - Part 1-2: General
    requirements for basic safety and essential
    performance - Collateral standard: Electromagnetic
    compatibility - Requirements and tests
206 Medical electrical equipment - Part 1-6: General
    requirements for basic safety and essential
    performance - Collateral Standard: Usability
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

Defines 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.

Committee
TC 121
DocumentType
Standard
ISBN
978-1-4883-0341-8
Pages
68
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy

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
ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
ISO 80601-2-67:2014 Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
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 8835-7:2011 Inhalational anaesthesia systems — Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases
ISO 10083:2006 Oxygen concentrator supply systems for use with medical gas pipeline systems
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
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 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
CSA C22.2 No. 60601.1.2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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