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BS EN ISO 8536-2:2023

BS EN ISO 8536-2:2023

$142.49

Infusion equipment for medical use – Closures for infusion bottles

Published By Publication Date Number of Pages
BSI 2023 24
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This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. 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.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Shape and dimensions
11 5 Designation
6 Material
7 Requirements
7.1 General
7.2 Physical requirements
7.2.1 Hardness
7.2.2 Fragmentation
7.2.3 Spike penetration force
12 7.2.4 Spike retention/sealability
7.2.5 Resistance to ageing
7.3 Chemical requirements
7.4 Biological requirements
8 Labelling
13 Annex A (normative) Determination of fragments
15 Annex B (normative) Determination of spike penetration force
17 Annex C (normative) Spike retention/sealability
19 Annex D (normative) Closure piercing device
20 Bibliography

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BS EN ISO 8536-2:2023
$142.49