• DIN EN 1820:2009-12

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    ANAESTHETIC RESERVOIR BAGS

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-03-2021

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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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
    5 Prevention of electrostatic charges
    6 Requirements for bags supplied sterile
    7 Marking
    8 Information to be supplied by the
      manufacturer
    Annex A (informative) Test for leakage
    Annex B (normative) Determination of capacity
    Annex C (normative) Test for security of attachment
             of plain neck to 22 mm male conical connector
    Annex D (normative) Test for security of attachment of
             adaptor of assembled neck to bag
    Annex E (normative) Test for resistance to pressure
             required to distend the bag (pressure/volume)
    Annex F (informative) Test for resistance to pressure
             required to distend the bag using air (pressure/volume)
    Annex G (informative) Recommendations for materials
    Annex ZA (informative) Relationship between this European
             Standard and the Essential Requirements of EU Directive
             93/42/EEC Medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded

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

    EN ISO 4287:1998/A1:2009 GEOMETRICAL PRODUCT SPECIFICATIONS (GPS) - SURFACE TEXTURE: PROFILE METHOD - TERMS, DEFINITIONS AND SURFACE TEXTURE PARAMETERS
    ISO 4287:1997 Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters
    EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    EN ISO 4135:2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
    EN 980:2008 Symbols for use in the labelling of medical devices
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