I.S. EN ISO 11608-3:2022
Current
The latest, up-to-date edition.
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022)
Hardcopy , PDF
English
06-15-2022
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions.
4 Requirements
5 Test methods
6 Information supplied with the container
Annex A (informative) Medicinal product compatibility references – Requirements,
guidance, standards or compendia material
Annex B (informative) Historical references to previous editions
Annex C (informative) Theoretical support for resealability requirements
Annex D (informative) Reservoir and integrated fluid path leachables
Annex E (informative) Medicinal product compatibility
Annex F (informative) Primary container closure as compared to reservoir and fluid path
Bibliography
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