• I.S. EN ISO 7396-2:2007

    Current The latest, up-to-date edition.

    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:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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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)

    Describes 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)

    Development Note Supersedes I.S. EN 737-2 and I.S. ISO 7396. (06/2007)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    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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