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  • ISO 8536-2:2010

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Infusion equipment for medical use — Part 2: Closures for infusion bottles

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  31-01-2023

    Language(s):  French, English

    Published date:  01-03-2010

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 8536‑2:2010 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.

    The dimensional requirements are not applicable to barrier-coated closures.

    Closures specified in ISO 8536‑2:2010 are intended for single use only.

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

    Development Note Supersedes ISO/DIS 8536-2. (03/2010)
    Document Type Standard
    Product Note THIS STANDARD ALSO HAVE CORRECT VERSION FOR EN&FR:2010
    Publisher International Organization for Standardization
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    17/30346437 DC : 0 BS ISO 18250-7 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS FOR HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR INFUSION
    DIN EN ISO 8871-5:2015-08 (Draft) ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)
    I.S. EN ISO 8871-5:2016 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)
    BS EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates
    UNI EN ISO 8871-2 : 2014 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
    DIN EN ISO 8871-5 E : 2017 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)
    15/30324254 DC : 0 BS EN ISO 8871-5 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING
    17/30357486 DC : 0 BS EN ISO 15747 - PLASTIC CONTAINERS FOR INTRAVENOUS INJECTIONS
    00/560909 DC : DRAFT MAR 2000 BS ISO 8871-2 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
    DIN EN ISO 8871-2:2014-08 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003 + AMD.1:2005)
    EN ISO 8871-2:2004/A1:2014 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003/AMD 1:2005)
    I.S. EN ISO 8871-2:2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003)
    BS EN ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use Functional requirements and testing
    ISO 8871-2:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization
    ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
    EN ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
    EN ISO 8871-1 : 2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES
    UNE-EN ISO 8871-5:2017 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
    BS EN ISO 8871-2 : 2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
    DIN EN ISO 8871-5:2017-03 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)

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

    ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
    ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
    ISO 8536-3:2009 Infusion equipment for medical use Part 3: Aluminium caps for infusion bottles
    ISO 3302-1:2014 Rubber — Tolerances for products — Part 1: Dimensional tolerances
    ISO 3302-2:2008 Rubber Tolerances for products Part 2: Geometrical tolerances
    ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
    ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods
    ISO 8536-1:2011 Infusion equipment for medical use Part 1: Infusion glass bottles
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