Reference details
- Reference
- EN ISO 11608-3:2022
- Official title
- Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01)
- Organisation
- CEN
- Publisher status in source
- PublishedThis is the status recorded in the source, not a statement that this is the latest edition.
- Source access
- 19 October 2026
Research and application
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Product research routes
- Medical devices
Intended medical purpose, device classification and the evidence associated with design, performance and lifecycle controls.
- Packaging, logistics and handling equipment
Protection, transport conditions, package systems and equipment interfaces throughout distribution.
Questions for the evidence file
- Intended purpose
- Classification rationale
- Risk management
- Verification and performance evidence
- Clinical evidence scope
- Package-and-content configuration
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Legal citation
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