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
15-06-2022
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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Annex B (informative) Historical references to previous editions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
This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.
| Committee |
ISO/TC 84
|
| DocumentType |
Test Method
|
| Pages |
44
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11608-3:2022 | Identical |
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