PREN ISO 80601-2-70 : DRAFT 2013

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
    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) - Data interface requirements
Annex CC (informative) - Reference to the Essential Principles
Bibliography
Alphabetized index of defined terms used in this particular standard
Annex ZA (informative) - Relationship between this Document and
         the Essential Requirements of EU Directive 93/42/EEC

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 PATIENT.