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  • 15/30280904 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-10-2016

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General Requirements for AIRWAYS AND
       RELATED EQUIPMENT
    5 Materials
    6 Design requirements for airways and
       related equipment
    7 Requirements for airways and related
       equipment supplied sterile
    8 Cleaning, disinfection and sterilization
    9 Packaging
    10 Information supplied by the manufacturer
    Annex A (informative) - Rationale
    Annex B (informative) - Hazard identification for
            risk assessment
    Annex ZA (informative) - Relationship between
             this document and the Essential Requirements of
             EU Directive 93/42/EEC
    Bibliography

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

    Comment Closes On
    Committee CH/121/5
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 80601-2-69:2014 Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    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 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 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 80601-2-12:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
    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
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ANSI Z79.16 : 1983 CUFFED OROTRACHEAL AND NASOTRACHEAL TUBES FOR PROLONGED USE,
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 10524-2:2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators
    ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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