DIN EN ISO 11608-2:2012-12
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 (ISO 11608-2:2012)
Hardcopy , PDF
29-08-2022
English, German
01-12-2012
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Contents
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Colour coding
4.2 Materials
4.3 Dimensions
4.4 Patency of lumen
4.5 Needle points
4.6 Freedom from defects
4.7 Lubrication
4.8 Dislocation of measuring point at the patient-
end of type A needles
4.9 Bond between hub and needle tube
4.10 Unscrewing torque of the needle
4.11 Ease of assembly/disassembly
4.12 Sterility
5 Sampling
6 Preconditioning of needles
6.1 Preconditioning in dry heat atmosphere
6.2 Preconditioning in cold storage atmosphere
6.3 Preconditioning in cyclical atmosphere
7 Standard atmosphere and apparatus for tests
7.1 Standard test atmosphere
7.2 Test apparatus
8 Determination of dislocation of measuring point
at the patient-end of Type A needles
9 Bond between hub and needle tube
10 Unscrewing torque of the needle
11 Packaging
12 Information supplied by the manufacturer
12.1 General
12.2 Marking
12.3 Instructions for use
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.
| DocumentType |
Standard
|
| Pages |
25
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM 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 |
| UNI EN ISO 11608-2 : 2012 | Identical |
| NEN EN ISO 11608-2 : 2012 | Identical |
| NF EN ISO 11608-2 : 2012 | Identical |
| ISO 11608-2:2012 | Identical |
| NS EN ISO 11608-2 : 2012 | Identical |
| EN ISO 11608-2:2012 | Identical |
| SN EN ISO 11608-2 : 2012 | Identical |
| BS EN ISO 11608-2:2012 | Identical |
| DIN EN ISO 11608-4:2016-03 (Draft) | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| DIN ISO 11040-4:2007-10 | PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015) |
| DIN ISO 7000:2008-12 | Graphical symbols for use on equipment - Index and synopsis (ISO 7000:2004 + ISO 7000 Database:2008 up to ISO 7000-2750) |
| DIN EN ISO 7864:2015-01 (Draft) | STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO 7864:2016) |
| DIN EN ISO 11608-3:2013-01 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012) |
| DIN EN ISO 11608-1:2015-04 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
| ISO 15510:2014 | Stainless steels — Chemical composition |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| DIN ISO 2859-1:2014-08 | SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES - PART 1: SAMPLING SCHEMES INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION (ISO 2859-1:1999 + COR. 1:2001 + AMD.1:2011) |
| 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 |
| DIN EN 60068-2-30:2006-06 | ENVIRONMENTAL TESTING - PART 2-30: TESTS - TEST DB: DAMP HEAT, CYCLIC (12 H + 12 H CYCLE) |
| ISO 11608-3:2012 | Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers |
| DIN EN ISO 9626:2015-03 (Draft) | STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS (ISO 9626:2016) |
| DIN EN ISO 9000:2015-11 | QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015) |
| 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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