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ISO 11608-2 : 2012

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ISO 11608-2 : 2012

NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES

International Organization for Standardization

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Table of Contents

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

Abstract

This part of ISO 11608 specifies 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.

General Product Information

Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 84
Supersedes
  • ISO/DIS 11608-2 : 60.00 (2012)