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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)
Hardcopy , PDF
English, German
01-01-2013
29-08-2022
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Superseded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 |
| 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 |
| BS EN ISO 11608-3:2012 | Identical |
| ISO 11608-3:2012 | Identical |
| NBN EN ISO 11608-3 : 2012 | Identical |
| UNE-EN ISO 11608-3:2013 | Identical |
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