BS EN ISO 80601-2-69:2014

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
Annex ZA (informative) - Relationship between this
         Document and the Essential Requirements
         of EU Directive 93/42/EEC

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.