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BS EN ISO 11608-3:2022

BS EN ISO 11608-3:2022

$167.15

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 36
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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
2 undefined
5 European foreword
Endorsement notice
9 Foreword
10 Introduction
12 1 Scope
2 Normative references
13 3 Terms and definitions
14 4 Requirements
4.1 General
15 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
16 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
17 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
18 4.5.5 Reservoir and integrated fluid path leachables
4.5.6 Sterilization of the reservoir and/or integrated fluid path
19 4.6 Medicinal product leakage
5 Test methods
5.1 Resealability for multi-dose cartridges or reservoirs
20 5.2 Fragmentation (disc coring) – cartridges or reservoirs
21 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
22 Annex A (informative) Medicinal product compatibility references – Requirements, guidance, standards or compendia material
25 Annex B (informative) Historical references to previous editions
28 Annex C (informative) Theoretical support for resealability requirements
31 Annex D (informative) Reservoir and integrated fluid path leachables
33 Annex E (informative) Medicinal product compatibility
35 Annex F (informative) Primary container closure as compared to reservoir and fluid path
38 Bibliography

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BS EN ISO 11608-3:2022
$167.15