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BS EN ISO 11608-2:2022

BS EN ISO 11608-2:2022

$167.15

Needle-based injection systems for medical use. Requirements and test methods. Double-ended pen needles – Part 2: Needles

Published By Publication Date Number of Pages
BSI 2022 42
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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
2 undefined
4 European foreword
Endorsement notice
7 Foreword
9 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
13 4 Symbols
5 Requirements
5.1 Needle tube requirements
5.1.1 General
14 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
15 5.2.4 Needle points
5.2.5 Freedom from defects
5.2.6 Flow rate through the needle
16 5.2.7 Bond between hub and needle tube
17 5.2.8 Dislocation of measuring point at patient end
5.2.9 Ease of assembly
5.2.10 Sterility
18 5.2.11 Pyrogenicity
5.3 Functional compatibility with NISs
5.3.1 General
5.3.2 Dose delivery
19 5.3.3 Needle removal torque
20 6 Sampling
23 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
24 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
25 9.3 Ease of assembly
9.4 Functional compatibility with NISs
9.4.1 Sample quantity requirements
26 9.4.2 Test procedures for testing dose delivery
27 9.4.3 Procedure for testing needle hub removal torque
10 Packaging
11 Information supplied with the needle(s)
11.1 General
28 11.2 Marking
11.2.1 Marking on the unit packaging
29 11.2.2 Marking on the user packaging
30 11.3 Instructions for use
31 Annex A (normative) Determination of flow rate through needle
34 Annex B (informative) Needle bonding strength test method
35 Annex C (informative) Additional background for requirements
40 Bibliography

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BS EN ISO 11608-2:2022
$167.15