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ISO 8536-6

Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles

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Organization: ISO
Publication Date: 1 December 2016
Status: active
Page Count: 24
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.

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

ISO 8536-6
December 1, 2016
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection...
ISO 8536-6
November 15, 2009
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, which are used in...
ISO 8536-6
April 1, 1995
Infusion Equipment for Medical Use - Part 6: Freeze Drying Closures for Infusion Bottles First Edition
A description is not available for this item.

References

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...
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 15510 - Stainless steels - Chemical composition
Published by ISO on May 15, 2014
This International Standard lists the chemical compositions of stainless steels agreed by ISO/TC 17/SC 4, mainly on the basis of a composition of the specifications in existing ISO, ASTM, EN, JIS,...
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 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:
BS EN ISO 8871-5 - Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testing
Published by BSI on November 30, 2016
A description is not available for this item.
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:
ISO 8871-2 - Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization
Published by ISO on May 1, 2020
This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices. The physical and...
This document is referenced by:
BS EN ISO 8871-1 - Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
Published by BSI on September 8, 2004
A description is not available for this item.
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