EN ISO 80601-2-55:2018

European foreword
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
201.10Protection against unwanted and
      excessive radiation HAZARDS
201.11Protection against excessive temperatures
      and other HAZARDS
201.12Accuracy of controls and instruments
      and protection against hazardous outputs
201.13HAZARDOUS SITUATIONS and fault conditions
201.14PROGRAMMABLE ELECTRICAL MEDICAL
      SYSTEMS (PEMS)
201.15Construction of ME EQUIPMENT
201.16ME SYSTEMS
201.17Electromagnetic compatibility of ME
      EQUIPMENT and ME SYSTEMS
201.101 Interfering gas and vapour effects
201.102 Gas leakage
201.103 Port connectors for DIVERTING RGMs
201.104 Sampling flowrate
201.105 Contamination of breathing systems
201.106 FUNCTIONAL CONNECTION
202 Electromagnetic disturbances - Requirements and tests
206 USABILITY
208 General requirements, tests and guidance for
    ALARM SYSTEMS in MEDICAL ELECTRICAL
    EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
211 General requirements, tests and guidance
    for medical electrical equipment and medical
    electrical systems used in the home healthcare environment
212 General requirements, tests and guidance for
    MEDICAL ELECTRICAL EQUIPMENT and
    MEDICAL ELECTRICAL SYSTEMS intended
    for use in the EMERGENCY MEDICAL SERVICES
    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) - Test gas mixtures for calibration
Annex CC (informative) - Data interface requirements
Annex DD (informative) - Alphabetized index of defined
         terms used in this document
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the essential requirements
         of Directive 93/42/EEC [OJ L 169] aimed to be covered

ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient.ISO 80601-2-55:2018 specifies requirements for- anaesthetic gas monitoring,- carbon dioxide monitoring, and- oxygen monitoring.NOTE 1 An rgm can be either stand-alone me equipment or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator.ISO 80601-2-55:2018 is not applicable to an rgm intended for use with flammable anaesthetic agents.If a clause or subclause is specifically intended to be applicable to me equipment only or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+Amd 1:2012, 7.2.13 and 8.4.1.NOTE 2 Additional information can be found in IEC 60601‑1:2005+Amd 1:2012, 4.2.