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CEN
EN ISO 11608-2:2012

EN ISO 11608-2:2012

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)

Superseded date

28-05-2022

Published date

01-04-2012

Publisher

Comite Europeen de Normalisation

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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

ISO 11608-2:2012 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.

Committee
CEN/TC 205
DevelopmentNote
Supersedes PREN ISO 11608-2. (04/2012)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
Supersedes

03/113382 DC : DRAFT SEP 2003 BS EN ISO 21649 - NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS

ISO 15510:2014 Stainless steels — Chemical composition
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO/IEC Guide 98-1:2009 Uncertainty of measurement — Part 1: Introduction to the expression of uncertainty in measurement
ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
ISO 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels
IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)

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