Recognized standard
11040-4 Fourth edition 2024-06
FDA recognition 6-511 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-511 |
|---|---|
| Designation | 11040-4 Fourth edition 2024-06 |
| Title | Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 26, 2025 |
| Scope (excerpt) | This document specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods. This document also specifies components that are part of the sterilized subassembled syringe ready for filling. This document is applicable to - tubing-glass barrels… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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: