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BS EN ISO 11608-2:2022 – TC

BS EN ISO 11608-2:2022 – TC

$217.84

Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods – Double-ended pen needles

Published By Publication Date Number of Pages
BSI 2022 98
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This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1. This document is not applicable to the following: —    needles for dental use; —    pre-attached syringe needles; —    hypodermic needles; —    needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular); —    materials that form the medicinal product contact surfaces of the primary container closure. However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them. NOTE       Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608?3, and hypodermic needles provided separately are covered in ISO 7864.

PDF Catalog

PDF Pages PDF Title
1 30459546
57 A-30381878
58 undefined
60 European foreword
Endorsement notice
63 Foreword
65 Introduction
67 1 Scope
2 Normative references
3 Terms and definitions
69 4 Symbols
5 Requirements
5.1 Needle tube requirements
5.1.1 General
70 5.1.2 Needle tubing materials
5.1.3 Tubing characteristics
5.2 Double-ended pen needle requirements
5.2.1 General
5.2.2 Biocompatibility
5.2.3 Dimensions for double-ended pen needle assembly
71 5.2.4 Needle points
5.2.5 Freedom from defects
5.2.6 Flow rate through the needle
72 5.2.7 Bond between hub and needle tube
73 5.2.8 Dislocation of measuring point at patient end
5.2.9 Ease of assembly
5.2.10 Sterility
74 5.2.11 Pyrogenicity
5.3 Functional compatibility with NISs
5.3.1 General
5.3.2 Dose delivery
75 5.3.3 Needle removal torque
76 6 Sampling
79 7 Preconditioning of needles
7.1 Preconditioning in a dry-heat, cold storage and damp heat atmosphere
7.2 Preconditioning in a cyclical atmosphere
8 Standard atmosphere and test apparatus
8.1 Standard test atmosphere
8.2 Test gauge
80 8.3 Test apparatus
9 Test methods
9.1 Bond between hub and needle tube
9.2 Determination of dislocation of measuring point at patient end
81 9.3 Ease of assembly
9.4 Functional compatibility with NISs
9.4.1 Sample quantity requirements
82 9.4.2 Test procedures for testing dose delivery
83 9.4.3 Procedure for testing needle hub removal torque
10 Packaging
11 Information supplied with the needle(s)
11.1 General
84 11.2 Marking
11.2.1 Marking on the unit packaging
85 11.2.2 Marking on the user packaging
86 11.3 Instructions for use
87 Annex A (normative) Determination of flow rate through needle
90 Annex B (informative) Needle bonding strength test method
91 Annex C (informative) Additional background for requirements
96 Bibliography

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BS EN ISO 11608-2:2022 - TC
$217.84