NEN EN ISO 11608-3 : 2012
Current
The latest, up-to-date edition.
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS
23-11-2012
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
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