Recognized standard
8536-4 Sixth edition 2019-09
FDA recognition 6-447 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-447 |
|---|---|
| Designation | 8536-4 Sixth edition 2019-09 |
| Title | Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this document are to provide guidance on specifications relating to the quality… |
At a glance
- 10–99 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: