BS EN ISO 80601-2-12:2011

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 Gas connections
    201.102 Requirements for the VBS and ACCESSORIES
    201.103 Spontaneous breathing during loss of power supply
    201.104 Training
    201.105 Indication of duration of operation
    201.106 SIGNAL INPUT/OUTPUT PART
    201.108 Timed ventilatory pause
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
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
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 a ventilator in combination with its accessories, hereafter referred to as me equipment: - intended to be attended by a professional operator for those patients who are dependent on mechanical ventilation; and - intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility.