PREN ISO 11608-2 : DRAFT 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
01-04-2012
12-01-2013
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 the patient-end
9 Bond between hub and needle tube
10 Packaging
11 Test method for needle/injector systems
compatibility validation
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 which fulfil the specifications of ISO 11608-1.
| Committee |
TC 205
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| 10/30209603 DC : 0 | Identical |
| ISO 683-13:1974 | Heat-treated steels, alloy steels and free-cutting steels Part 13: Wrought stainless steels |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| 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 6009:2016 | Hypodermic needles for single use Colour coding for identification |
| 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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