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BS EN ISO 8536-2:2023 – TC

BS EN ISO 8536-2:2023 – TC

$186.33

Tracked Changes. Infusion equipment for medical use – Closures for infusion bottles

Published By Publication Date Number of Pages
BSI 2023 52
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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
30 undefined
32 European foreword
Endorsement notice
34 Foreword
35 Introduction
37 1 Scope
2 Normative references
3 Terms and definitions
38 4 Shape and dimensions
39 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
40 7.2.4 Spike retention/sealability
7.2.5 Resistance to ageing
7.3 Chemical requirements
7.4 Biological requirements
8 Labelling
41 Annex A (normative) Determination of fragments
43 Annex B (normative) Determination of spike penetration force
45 Annex C (normative) Spike retention/sealability
47 Annex D (normative) Closure piercing device
48 Bibliography

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BS EN ISO 8536-2:2023 - TC
$186.33