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Standard [CURRENT]

DIN EN ISO 8536-1:2011-12

Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011); German version EN ISO 8536-1:2011

German title
Infusionsgeräte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO 8536-1:2011); Deutsche Fassung EN ISO 8536-1:2011
Publication date
2011-12
Original language
German
Pages
15

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Publication date
2011-12
Original language
German
Pages
15
DOI
https://dx.doi.org/10.31030/1823530

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Overview

Infusion bottles are suitable primary packaging materials for the storage of infusion solutions until they are administered to the patient. Due to the direct contact between infusion solution and the primary container components and in view of the extended storage periods, it is essential to avoid possible interactions in order to guarantee the patient's safety. Adequate means to achieve this goal include the proper selection of the primary packaging materials, the choice of suitable package design and the availability of specific criteria and methods for testing of individual container systems. This standard specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use. This standard has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" (secretariat: DIN, Germany). It has been adopted without any modifications as a European Standard. At DIN, the German Institute for Standardization e. V., Working Committee NA 063-02-03 AA "Verpackungssysteme für die Befüllung und Applikation von medizinischen Produkten" ("Packaging systems for filling and application of medical products") is responsible at the Medical Standards Committee (NAMed). The new edition of DIN EN ISO 8536-1 takes into account updates of the normative references and further editorial revisions.

Content
ICS
11.040.20
DOI
https://dx.doi.org/10.31030/1823530
Replacement amendments

This document replaces DIN EN ISO 8536-1:2008-06 .

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