BS EN ISO 11608-2:2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Sampling
6 Pre-conditioning of needles
7 Standard atmosphere and apparatus for tests
8 Determination of dislocation of measuring
   point at patient end
9 Bond between hub and needle tube
10 Packaging
11 Test method for validating the compatibility
   of needles and injector systems
12 Information supplied by the manufacturer
Annex A (normative) - Determination of flow rate
        through needle
Bibliography

Describes requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.

This part of ISO11608 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO11608-1.

It is not applicable to:

• needles for dental use;

• pre-filled syringe needles;

• needles pre-assembled by the manufacturer;

• needles not requiring assembly or attachment to the NIS.