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  • BS EN ISO 7396-2 : 2007

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    MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2007

    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
       4.1 Safety
       4.2 Alternative construction
       4.3 Materials
       4.4 Continuity of operation
    5 Power device
    6 Indicating systems
    7 Pipelines, connecting assemblies and disposal hoses
    8 Disposal system characteristics and test methods for
       pressure and flow
       8.1 Requirements
       8.2 Test methods for pressure and flow
       8.3 Means to prevent backflow
    9 Terminal units
    10 Marking and colour coding
       10.1 Marking
       10.2 Colour coding
       10.3 Test for durability
    11 Pipeline installation
    12 Testing, commissioning and certification
       12.1 General
       12.2 General requirements for tests
       12.3 Tests, inspections and checks
       12.4 Requirements for tests, inspections and checks
            listed in 12.3
       12.5 Certification of the system
       12.6 Extensions or modifications
    13 Information to be supplied by the manufacturer
       13.1 General
       13.2 Instructions for use
       13.3 Operational management information
       13.4 "As-installed" drawings
       13.5 Electrical diagrams
    Annex A (informative) Guidelines for power devices consisting
            of fans, blowers or dedicated vacuum pumps
    Annex B (informative) Example of procedure for testing and
            commissioning
    Annex C (informative) Typical forms for certification of
            AGS disposal systems
    Annex D (informative) Risk management checklist
    Annex E (informative) Rationale
    Annex ZA (informative) Relationship between this International
             Standard and the Essential Requirements of EU
             Directive 93/42/EC on Medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies requirements for the design, installation, function, performance, documentation, testing and commissioning of anaesthetic gas scavenging disposal systems to ensure patient safety and to minimize exposure of the operator and other persons to anaesthetic gases and vapours.

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

    Committee CH/121/6
    Development Note Supersedes 05/30128373 DC. (05/2007) Supersedes BS EN 737-2. (07/2007)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
    EN 740:1998/A1:2004 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    ISO 9170-2:2008 Terminal units for medical gas pipeline systems Part 2: Terminal units for anaesthetic gas scavenging systems
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    EN 1041:2008+A1:2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    NFPA 99 : 2018 HEALTH CARE FACILITIES CODE
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 13348 : 2016 COPPER AND COPPER ALLOYS - SEAMLESS, ROUND COPPER TUBES FOR MEDICAL GASES OR VACUUM
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 7396-1:2016 Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum
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