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ISO - DIS 8362-2

Injection containers and accessories — Part 2: Closures for injection vials

pending
Organization: ISO
Publication Date: 28 August 2023
Status: pending
Page Count: 11
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.

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

Closures specified in this document are intended for single use only.

NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Document History

DIS 8362-2
August 28, 2023
Injection containers and accessories — Part 2: Closures for injection vials
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The dimensional requirements are...
8362-2 AMD 1
August 1, 2022
Injection containers and accessories — Part 2: Closures for injection vials AMENDMENT 1
A description is not available for this item.
ISO 8362-2
October 1, 2015
Injection containers and accessories - Part 2: Closures for injection vials
This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The dimensional...
ISO 8362-2
October 15, 2008
Injection containers and accessories — Part 2: Closures for injection vials
This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The dimensional...
ISO 8362-2
January 1, 1988
Injection Containers for Injectables and Accessories - Part 2: Closures for Injection Vials First Edition; (CEN EN 28362-2: 1993)
A description is not available for this item.

References

This document references:
ISO 15378 - Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
Published by ISO on September 1, 2017
In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs...
This document references:
ISO 2230 - Rubber Products - Guidelines for Storage
Published by ISO on April 15, 2002
This International Standard gives guidelines for the inspection, recording procedures, packaging and storage of products, assemblies and components made from vulcanized or thermoplastic rubber prior...
This document references:
ISO 3302-1 - Rubber - Tolerances for products - Part 1: Dimensional tolerances
Published by ISO on July 15, 2014
This part of ISO 3302 specifies classes of dimensional tolerances and their values for moulded, extruded, and calendared solid rubber products. The relevant test methods necessary for the...
This document references:
ISO 3302-2 - Rubber — Tolerances for products — Part 2: Geometrical tolerances
Published by ISO on October 1, 2008
This part of ISO 3302 specifies the following geometrical tolerances for moulded and extruded solid rubber products, including those with metal inserts: — flatness tolerance; — parallelism tolerance;...
This document references:
ISO 48-4 - Rubber, vulcanized or thermoplastic - Determination of hardness - Part 4: Indentation hardness by durometer method (Shore hardness)
Published by ISO on August 1, 2018
This document specifies a method for determining the indentation hardness (Shore hardness) of vulcanized or thermoplastic rubber using durometers with the following scales: — the A scale for rubbers...
This document references:
ISO 8362-1 - Injection containers and accessories - Part 1: Injection vials made of glass tubing
Published by ISO on August 1, 2018
This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance...
This document references:
ISO 8362-4 - Injection containers and accessories — Part 4: Injection vials made of moulded glass
Published by ISO on September 1, 2011
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...
This document references:
ISO 8871-1 - Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
Published by ISO on October 1, 2003
This part of ISO 8871 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous...
This document references:
ISO 8871-4 - Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods
Published by ISO on June 15, 2006
A description is not available for this item.
This document references:
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...
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