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    ISO 11040-5:2012

    Current The latest, up-to-date edition.

    Prefilled syringes — Part 5: Plunger stoppers for injectables

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

    Language(s):  English, French

    Published date:  20-01-2012

    Publisher:  International Organization for Standardization

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

    Committee ISO/TC 76
    Development Note Supersedes ISO/DIS 11040-5. (01/2012)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    BS ISO 11040-6:2012 Prefilled syringes Plastic barrels for injectables
    UNI EN ISO 8871-2 : 2014 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
    17/30357741 DC : 0 BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
    DIN ISO 11040-4 E : 2017 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    10/30208782 DC : DRAFT DEC 2010 BS EN ISO 11608-3 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS
    BS ISO 11040-4:2015 Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling
    ISO 11040-8:2016 Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
    BS EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates
    13/30273499 DC : 0 BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
    ISO 11040-6:2012 Prefilled syringes Part 6: Plastic barrels for injectables
    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)
    15/30304642 DC : 0 BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
    ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
    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
    BS EN 30-1-2:2012 Domestic cooking appliances burning gas. Safety Appliances having forced-convection ovens and/or grills
    EN 30-1-2:2012 Domestic cooking appliances burning gas - Safety - Part 1-2: Appliances having forced-convection ovens and/or grills
    EN ISO 8871-1 : 2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES
    DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    BS EN ISO 8871-2 : 2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
    DIN ISO 11040-4:2017-07 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)

    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 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
    ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
    ISO 2230:2002 Rubber products — Guidelines for storage
    ISO 3302-1:2014 Rubber — Tolerances for products — Part 1: Dimensional tolerances
    ISO 9997:1999 Dental cartridge syringes
    ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    ISO 8362-5:2016 Injection containers and accessories Part 5: Freeze drying closures for injection vials
    ISO 9001:2015 Quality management systems — Requirements
    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
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