SN EN ISO 11608-2 : 2012

Contents
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Colour coding
4.2 Materials
4.3 Dimensions
4.4 Patency of lumen
4.5 Needle points
4.6 Freedom from defects
4.7 Lubrication
4.8 Dislocation of measuring point at the patient-
    end of type A needles
4.9 Bond between hub and needle tube
4.10 Unscrewing torque of the needle
4.11 Ease of assembly/disassembly
4.12 Sterility
5 Sampling
6 Preconditioning of needles
6.1 Preconditioning in dry heat atmosphere
6.2 Preconditioning in cold storage atmosphere
6.3 Preconditioning in cyclical atmosphere
7 Standard atmosphere and apparatus for tests
7.1 Standard test atmosphere
7.2 Test apparatus
8 Determination of dislocation of measuring point
    at the patient-end of Type A needles
9 Bond between hub and needle tube
10 Unscrewing torque of the needle
11 Packaging
12 Information supplied by the manufacturer
12.1 General
12.2 Marking
12.3 Instructions for use
Bibliography

ISO 11608/2 provides the requirements and test methods for single-use, double-ended, sterile needles for pen-injectors which fulfil the specifications of ISO 11608/1.