NEN EN ISO 11608-3 : 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

Defines the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1.