Recognized standard
1135-4 Seventh edition 2025-05
FDA recognition 6-514 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-514 |
|---|---|
| Designation | 1135-4 Seventh edition 2025-05 |
| Title | Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed |
| 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 single use transfusion gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. It also provides guidance on specifications relating to the quality and performance of… |
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: