Recognized standard
11040-4 Third edition 2015-04-01
FDA recognition 6-464 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-464 |
|---|---|
| Designation | 11040-4 Third edition 2015-04-01 |
| Title | Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)] |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of ISO 11040 applies to - tubing-glass barrels (single-chamber design) for injection preparations, and - sterilized subassembled syringes ready for filling. It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods. This part of ISO 11040… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: