EN ISO 11608-2:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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)
01-04-2012
28-05-2022
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Superseded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 |
| Standards | Relationship |
| DS EN ISO 11608-2 : 2012 | Identical |
| I.S. EN ISO 11608-2:2012 | Identical |
| NBN EN ISO 11608-2 : 2012 | Identical |
| DIN EN ISO 11608-2:2012-12 | Identical |
| NEN EN ISO 11608-2 : 2012 | Identical |
| ISO 11608-2:2012 | Identical |
| NS EN ISO 11608-2 : 2012 | Identical |
| PN EN ISO 11608-2 : 2012 | Identical |
| BS EN ISO 11608-2:2012 | Identical |
| NF EN ISO 11608-2 : 2012 | Identical |
| UNE-EN ISO 11608-2:2012 | Identical |
| 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) |