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CSA C22.2.80601-2-67 : 2017

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CSA C22.2.80601-2-67 : 2017

MEDICAL ELECTRICAL EQUIPMENT - PART 2-67: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONSERVING EQUIPMENT

Canadian Standards Association

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Table of Contents

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

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.

General Product Information

Document Type Standard
Status Current
Publisher Canadian Standards Association
Supersedes
  • CSA Z18779 : 2008
  • CSA Z18779 : 2008 : R2013
  • CSA Z18779 : 2008