Recognized standard
7886-4 Second Edition 2018-11
FDA recognition 6-485 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-485 |
|---|---|
| Designation | 7886-4 Second Edition 2018-11 |
| Title | Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable… |
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: