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Standard [WITHDRAWN]

DIN ISO 8536-6:2012-09

Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2009)

German title
Infusionsgeräte zur medizinischen Verwendung - Teil 6: Gefriertrocknungsstopfen für Infusionsflaschen (ISO 8536-6:2009)
Publication date
2012-09
Original language
German
Pages
23

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Publication date
2012-09
Original language
German
Pages
23

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Overview

This standard specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1. The closures are used in connection with the freeze drying of drugs and biological materials. The necessary test methods are also part of the standard. With respect to DIN ISO 8536-6:1996-07, technical modifications also have been made in addition to editorial modifications. This includes the incorporation of requirements for the integrity of the container closure, modifications regarding the requirements for the materials, hardness, resistance to ageing, residual moisture, self-sealing and container closure seal integrity as well as revision of the test for the determination of the fragments and the determination of spike penetration force. The underlying International Standard ISO 8536-6:2009 has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" with the participation of German experts. At DIN, the German Institute for Standardization e. V., the responsible committee is Working Committee NA 063-02-15 AA "Elastomere Pharmapackmittel und zugehörige Komponenten" ("Elastomeric pharmaceutical packagings and associated components") of the Medical Standards Committee (NAMed).

Content
ICS
11.040.20
Replacement amendments

This document replaces DIN ISO 8536-6:1996-07 .

This document has been replaced by: DIN ISO 8536-6:2017-09 .

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