FDA-recognized standard · General Plastic Surgery/General Hospital
ISO 8536-4: Infusion equipment for medical use - Part 4: Infusion sets for single use gravity feed
Yes. FDA recognizes ISO 8536-4 Sixth edition 2019-09 as recognition 6-447, entered 2020-07-06.
Recognized editions of ISO 8536-4
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 6-447 | ISO 8536-4 Sixth edition 2019-09 | 2020-07-06 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 8536-4: 21 CFR 880.5440.
Product codes that cite ISO 8536-4
11 FDA product codes cite ISO 8536-4, including BRZ, CAK, FMG, FPA, FPB.
- BRZ
- CAK
- FMG
- FPA Set, Administration, Intravascular
- FPB
- FPK
- LHI Set, I.V. Fluid Transfer
- MJF
- NEP
- ODI
- OJA
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.