DIN EN ISO 11608-3:2013-01
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 3: Finished containers (ISO 11608-3:2012)
Hardcopy , PDF
08-29-2022
English, German
01-01-2013
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Freedom from leakage
4.2 Initiating force
4.3 Sustaining force
4.4 Dimensions
4.5 Eccentricity
4.6 Visibility of the medicinal product
4.7 Meniscus
4.8 Resealability
4.9 Cap
4.10 Plunger and disc
4.11 Material of the cylinder
4.12 Lubrication
4.13 Dose accuracy
4.14 Deliverable volume and last-dose
accuracy
5 Test Methods
5.1 Test apparatus
5.2 Test conditions
5.3 Test fluid
5.4 Analytical approach
5.5 Leakage (attribute)
5.6 Forces required to initiate and
sustain plunger movement (attribute)
5.7 Dimensions (attribute)
5.8 Eccentricity (attribute)
5.9 Meniscus (attribute)
5.10 Resealability (attribute)
5.11 Dose accuracy (variable)
5.12 Deliverable volume (attribute)
5.13 Last-dose accuracy (variable)
6 Information supplied by the manufacturer
Bibliography
Describes the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1.
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 11608-3 : 2012 | Identical |
| NF EN ISO 11608-3 : 2012 | Identical |
| NEN EN ISO 11608-3 : 2012 | Identical |
| I.S. EN ISO 11608-3:2012 | Identical |
| NS EN ISO 11608-3 : 2012 | Identical |
| EN ISO 11608-3:2012 | Identical |
| SN EN ISO 11608-3:2012 | Identical |
| UNI EN ISO 11608-3 : 2013 | Identical |
| BS EN ISO 11608-3:2012 | Identical |
| ISO 11608-3:2012 | Identical |
| UNE-EN ISO 11608-3:2013 | Identical |
| NBN EN ISO 11608-3 : 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 EN ISO 11608-2:2012-12 | Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012) |
| DIN EN ISO 7864:2015-01 (Draft) | STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO 7864:2016) |
| ISO 13926-1:2004 | Pen systems Part 1: Glass cylinders for pen-injectors for medical use |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| DIN ISO 13926-1:2005-10 | PEN SYSTEMS - PART 1: GLASS CYLINDERS FOR PEN-INJECTORS FOR MEDICAL USE |
| ISO 11608-1:2014 | Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems |
| ISO 11040-3:2012 | Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges |
| DIN EN ISO 7886-1:2015-10 (Draft) | STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE |
| ISO 11608-2:2012 | Needle-based injection systems for medical use Requirements and test methods Part 2: Needles |
| ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| ISO 13926-2:2011 | Pen systems Part 2: Plunger stoppers for pen-injectors for medical use |
| 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 |
| DIN EN ISO 8537:2008-10 | STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016) |
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