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  • EN ISO 80601-2-55:2018

    Current The latest, up-to-date edition.

    Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)

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    Published date:  28-02-2018

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 215
    Development Note Supersedes PREN ISO 80601-2-55. (01/2012) Supersedes EN ISO 21647. (07/2012) Supersedes UNE EN ISO 21647. (01/2015)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
    IEC 60038:2009 IEC standard voltages
    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    ASTM F 1452 : 2001 Standard Specification for Minimum Performance and Safety Requirements for Anesthetic Gas Monitors
    ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
    ISO/TS 29041:2008 Gas mixtures — Gravimetric preparation — Mastering correlations in composition
    EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    MIL-STD-810 Revision G:2008 ENVIRONMENTAL ENGINEERING CONSIDERATIONS AND LABORATORY TESTS
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    IEC 60721-3-7:1995+AMD1:1996 CSV Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO 6143:2001 Gas analysis — Comparison methods for determining and checking the composition of calibration gas mixtures
    ISO 14159:2002 Safety of machinery — Hygiene requirements for the design of machinery
    ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ASTM F 2761 : 2009 : R2013 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
    IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
    ISO 80000-1:2009 Quantities and units — Part 1: General
    IEC TR 60721-4-7:2001+AMD1:2003 CSV Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use
    ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 6142-1:2015 Gas analysis Preparation of calibration gas mixtures Part 1: Gravimetric method for Class I mixtures
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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