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SNV - SN EN ISO 8362-2

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

inactive
Organization: SNV
Publication Date: 1 November 2010
Status: inactive
Page Count: 14
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

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 requirements are not applicable to barrier-coated closures.

Closures specified in this part of ISO 8362 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

SN EN ISO 8362-2/A1
September 1, 2022
Injection containers and accessories - Part 2: Closures for injection vials; Amendment A1
A description is not available for this item.
SN EN ISO 8362-2
January 1, 2016
Injection containers and accessories - Part 2: Closures for injection vials
A description is not available for this item.
SN EN ISO 8362-2
November 1, 2010
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...

References

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 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 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 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 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.
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