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  • ISO 8362-1:2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Injection containers and accessories Part 1: Injection vials made of glass tubing

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

    Superseded date:  26-06-2019

    Language(s): 

    Published date:  07-12-2009

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 8362-1:2009 specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements of those containers.

    ISO 8362-1:2009 applies to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.

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

    Development Note DRAFT ISO/DIS 8362-1 is also available for this standard. (08/2017)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Superseded
    Superseded By
    Supersedes

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

    15/30315528 DC : 0 BS ISO 4802-2 - GLASSWARE - HYDROLYTIC RESISTANCE OF THE INTERIOR SURFACES OF GLASS CONTAINERS - PART 2: DETERMINATION BY FLAME SPECTROMETRY AND CLASSIFICATION
    09/30178946 DC : 0 BS ISO 4802-1 - GLASSWARE - HYDROLYTIC RESISTANCE OF THE INTERIOR SURFACES OF GLASS CONTAINERS - PART 1: DETERMINATION BY TITRATION METHOD AND CLASSIFICATION
    09/30178949 DC : 0 BS ISO 4802-2 - GLASSWARE - HYDROLYTIC RESISTANCE OF THE INTERIOR SURFACES OF GLASS CONTAINERS - PART 2: DETERMINATION BY FLAME SPECTROMETRY AND CLASSIFICATION
    BS ISO 4802-1:2016 Glassware. Hydrolytic resistance of the interior surfaces of glass containers Determination by titration method and classification
    ISO 4802-1:2016 Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification
    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)
    ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
    DIN ISO 10985:2009-12 Caps made of aluminium-plastics combinations for infusion bottles and injection vials - Requirements and test methods (ISO 10985:2009)
    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)
    BS EN ISO 8362-7:2010 Injection containers and accessories Injection caps made of aluminium-plastics combinations without overlapping plastics part
    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
    UNE-EN ISO 8362-7:2011 Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006)
    BS EN ISO 7864:2016 Sterile hypodermic needles for single use. Requirements and test methods
    DIN ISO 8362-7:2007-06 INJECTION CONTAINERS AND ACCESSORIES - PART 7: INJECTION CAPS MADE OF ALUMINIUM-PLASTICS COMBINATIONS WITHOUT OVERLAPPING PLASTICS PART
    I.S. EN ISO 7864:2016 STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014)
    BS 3970-2:1991 Sterilizing and disinfecting equipment for medical products Specification for steam sterilizers for aqueous fluids in sealed rigid containers
    DIN ISO 10985 E : 2009 CAPS MADE OF ALUMINIUM-PLASTICS COMBINATIONS FOR INFUSION BOTTLES AND INJECTION VIALS - REQUIREMENTS AND TEST METHODS
    UNI EN ISO 8362-7 : 2011 INJECTION CONTAINERS AND ACCESSORIES - PART 7: INJECTION CAPS MADE OF ALUMINIUM-PLASTICS COMBINATIONS WITHOUT OVERLAPPING PLASTICS PART
    BS ISO 4802-2:2016 Glassware. Hydrolytic resistance of the interior surfaces of glass containers Determination by flame spectrometry and classification
    DIN EN ISO 8362-2:2016-02 Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015)
    EN ISO 8362-2:2015 Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015)
    14/30296389 DC : 0 BS EN ISO 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS
    BS EN ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use Functional requirements and testing
    BS EN ISO 8362-2:2015 Injection containers and accessories Closures for injection vials
    NF EN ISO 8362-7 : 2011 INJECTION CONTAINERS AND ACCESSORIES - PART 7: INJECTION CAPS MADE OF ALUMINIUM-PLASTICS COMBINATIONS WITHOUT OVERLAPPING PLASTICS PART
    04/30086336 DC : 0 BS ISO 8871-5 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING
    I.S. EN ISO 8362-7:2010 INJECTION CONTAINERS AND ACCESSORIES - PART 7: INJECTION CAPS MADE OF ALUMINIUM-PLASTICS COMBINATIONS WITHOUT OVERLAPPING PLASTICS PART
    ISO 4802-2:2016 Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification
    I.S. EN ISO 8362-2:2015 INJECTION CONTAINERS AND ACCESSORIES - PART 2: CLOSURES FOR INJECTION VIALS (ISO 8362-2:2015)
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 8362-2:2015 Injection containers and accessories — Part 2: Closures for injection vials
    UNE-EN ISO 7864:2017 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    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 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN ISO 8362-7:2010 Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006)
    DIN EN ISO 8362-7:2011-03 Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006)
    15/30315525 DC : 0 BS ISO 4802-1 - GLASSWARE - HYDROLYTIC RESISTANCE OF THE INTERIOR SURFACES OF GLASS CONTAINERS - PART 1: DETERMINATION BY TITRATION METHOD AND CLASSIFICATION
    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)
    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)
    09/30196282 DC : DRAFT AUG 2009 BS ISO 8362-6 - INJECTION CONTAINERS AND ACCESSORIES - PART 6: CAPS MADE OF ALUMINIUM-PLASTICS COMBINATIONS FOR INJECTION VIALS
    ISO 10985:2009 Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test methods
    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 720:1985 Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classification
    ISO 1101:2017 Geometrical product specifications (GPS) — Geometrical tolerancing — Tolerances of form, orientation, location and run-out
    ISO 4802-2:2016 Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification
    ISO 4802-1:2016 Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification
    ISO 719:1985 Glass Hydrolytic resistance of glass grains at 98 degrees C Method of test and classification
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