Table of Contents

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 BREATHING GAS PATHWAY connectors
201.102 Requirements for the BREATHING GAS PATHWAY
        and ACCESSORIES
201.103 FUNCTIONAL CONNECTION
201.104 Training
202 Medical electrical equipment - Part 1-2: General
        requirements for basic safety and essential performance -
        Collateral standard: Electromagnetic disturbances -
        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) - Data interface requirements
Annex CC (informative) - Reference to the Essential Principles
Bibliography
Alphabetized index of defined terms used in this particular standard

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SLEEP APNOEA BREATHING THERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT, intended to alleviate the symptoms of PATIENTS who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the PATIENT.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Canadian Standards Association
Pages
ISBN