BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Needle-based injection systems for medical use. Requirements and test methods Needles
Hardcopy , PDF
07-15-2022
English
04-30-2012
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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
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.
| Committee |
CH/84
|
| DevelopmentNote |
Supersedes 97/563388 DC (03/2005) Supersedes 10/30209603 DC. (04/2012)
|
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| Standards | Relationship |
| ONORM EN ISO 11608-2 : 2012 | Identical |
| ISO 11608-2:2012 | Identical |
| NF EN ISO 11608-2 : 2012 | Identical |
| NS EN ISO 11608-2 : 2012 | Identical |
| EN ISO 11608-2:2012 | Identical |
| UNE-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 |
| UNI EN ISO 11608-2 : 2012 | Identical |
| SN EN ISO 11608-2 : 2012 | Identical |
| NEN EN ISO 11608-2 : 2012 | Identical |
| 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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