Recognized standard
7886-2 Second edition 2020-04
FDA recognition 6-439 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-439 |
|---|---|
| Designation | 7886-2 Second edition 2020-04 |
| Title | Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps. This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes… |
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: