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BS EN ISO 11608-3:2022 – TC

BS EN ISO 11608-3:2022 – TC

$217.84

Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods – Containers and integrated fluid paths

Published By Publication Date Number of Pages
BSI 2022 92
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This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1. It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture. This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022). This document is not applicable to the following products: —    sterile hypodermic needles; —    sterile hypodermic syringes; —    sterile single-use syringes, with or without needle, for insulin; —    containers that can be refilled multiple times; —    containers intended for dental use; —    catheters or infusion sets that are attached or assembled separately by the user.

PDF Catalog

PDF Pages PDF Title
54 undefined
57 European foreword
Endorsement notice
61 Foreword
62 Introduction
64 1 Scope
2 Normative references
65 3 Terms and definitions
66 4 Requirements
4.1 General
67 4.2 Container integrity
4.2.1 Container Closure Integrity (CCI)
4.2.2 Resealability — All multi-dose cartridges or reservoirs with discs
4.2.3 Fragmentation (disc coring) – cartridges or reservoirs with discs
68 4.3 Cannula requirements (as part of the fluid path)
4.3.1 Rigid needles
4.3.2 Soft cannulas
4.4 Fluid line connections
4.5 Medicinal product compatibility
4.5.1 General
69 4.5.2 Medicinal product compatibility with reservoir and integrated fluid path materials
4.5.3 Reservoir and integrated fluid path particulate matter
4.5.4 Reservoir and fluid path pyrogenicity
70 4.5.5 Reservoir and integrated fluid path leachables
4.5.6 Sterilization of the reservoir and/or integrated fluid path
71 4.6 Medicinal product leakage
5 Test methods
5.1 Resealability for multi-dose cartridges or reservoirs
72 5.2 Fragmentation (disc coring) – cartridges or reservoirs
73 5.3 Sub-visible particulates
5.4 Visible particulates
6 Information supplied with the container
6.1 General
6.2 Marking on the unit packaging
74 Annex A (informative) Medicinal product compatibility references – Requirements, guidance, standards or compendia material
77 Annex B (informative) Historical references to previous editions
80 Annex C (informative) Theoretical support for resealability requirements
83 Annex D (informative) Reservoir and integrated fluid path leachables
85 Annex E (informative) Medicinal product compatibility
87 Annex F (informative) Primary container closure as compared to reservoir and fluid path
90 Bibliography

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BS EN ISO 11608-3:2022 - TC
$217.84