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ISO 8362-4

Injection containers and accessories — Part 4: Injection vials made of moulded glass

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Organization: ISO
Publication Date: 1 September 2011
Status: active
Page Count: 12
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

This part of ISO 8362 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements for the containers.

It applies to colourless or amber glass containers moulded from borosilicate or soda-lime-silica glass, with or without an internal surface treatment, and intended to be used in the packaging, storage or transportation of products intended for injection.

Document History

ISO 8362-4
September 1, 2011
Injection containers and accessories — Part 4: Injection vials made of moulded glass
This part of ISO 8362 specifies the shape, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance...
ISO 8362-4
August 1, 2003
Injection containers and accessories Part 4: Injection vials made of moulded glass
A description is not available for this item.
ISO 8362-4
November 1, 1989
Injection Containers for Injectables and Accessories - Part 4: Injection Vials Made of Moulded Glass First Edition; (CEN EN 28362-4: 1993)
A description is not available for this item.

References

This document references:
ISO 4802-1 - Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification
Published by ISO on June 15, 2016
This part of ISO 4802 specifies: a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at 121 °C ± 1 °C for 60 min ± 1...
This document references:
ISO 4802-2 - Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification
Published by ISO on June 15, 2016
This part of ISO 4802 specifies: a) methods for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at (121 ± 1) °C for (60 ± 1) min....
This document references:
ISO 4802-1 - Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification
Published by ISO on June 15, 2016
This part of ISO 4802 specifies: a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at 121 °C ± 1 °C for 60 min ± 1...
This document references:
ISO 7459 - Glass Containers - Thermal Shock Resistance and Thermal Shock Endurance - Test Methods
Published by ISO on March 1, 2004
A description is not available for this item.
This document references:
ISO 7458 - Glass Containers - Internal Pressure Resistance - Test Methods
Published by ISO on March 1, 2004
A description is not available for this item.
This document references:
ISO 719 - Glass - Hydrolytic Resistance of Glass Grains at 98 Degrees C - Method of Test and Classification
Published by ISO on January 1, 1985
A description is not available for this item.
This document references:
ISO 4802-2 - Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification
Published by ISO on June 15, 2016
This part of ISO 4802 specifies: a) methods for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at (121 ± 1) °C for (60 ± 1) min....
This document is referenced by:
ISO 8871-5 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing
Published by ISO on October 15, 2016
This part of ISO 8871 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle. NOTE Functional...
This document is referenced by:
EN ISO 22413 - Transfer sets for pharmaceutical preparations - Requirements and test methods
Published by CEN on February 1, 2013
This International Standard applies to sterilized single use transfer sets that are used for pharmaceutical preparations.
This document is referenced by:
SN EN ISO 22413 - Transfer sets for pharmaceutical preparations - Requirements and test methods
Published by SNV on June 1, 2013
This International Standard applies to sterilized single use transfer sets that are used for pharmaceutical preparations.
This document is referenced by:
EN ISO 8871-5 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing
Published by CEN on November 1, 2016
This part of ISO 8871 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle. NOTE Functional...
This document is referenced by:
DIN EN ISO 8871-5 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016); German version EN ISO 8871-5:2016
Published by DIN on March 1, 2017
A description is not available for this item.
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