Recognized standard
11040-5 Third edition 2012-02-15
FDA recognition 6-278 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-278 |
|---|---|
| Designation | 11040-5 Third edition 2012-02-15 |
| Title | Prefilled syringes - Part 5: Plunger stoppers for injectables |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 20, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of ISO 11040 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for glass barrels (single-chamber design) for injection preparations in accordance with ISO 11040-4. Plunger stoppers specified in this part of ISO 11040 are intended for… |
At a glance
- 1–9 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: