FDA-recognized standard · General Plastic Surgery/General Hospital
ISO 23908: Sharps injury protection - Sharps protection mechanisms for single-use needles introducers for catheters and needles used for blood testing monitoring sampling and medical substance administration - Requirements and test methods
Yes. FDA recognizes ISO 23908 Second Edition 2024-12 as recognition 6-507, entered 2025-05-26. FDA also lists ISO 23908 First edition 2011-06-11 (recognition 6-273, transition period ending 2027-07-04).
Recognized editions of ISO 23908
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 6-507 | ISO 23908 Second Edition 2024-12 | 2025-05-26 | Complete | — |
| 6-273 | ISO 23908 First edition 2011-06-11 | 2014-01-30 | Complete | 2027-07-04 |
Regulations
FDA lists these classification regulations against ISO 23908: 21 CFR 872.4730, 21 CFR 880.5200, 21 CFR 880.5440, 21 CFR 880.5570, 21 CFR 880.5725, 21 CFR 880.5860, 21 CFR 880.5965, 21 CFR 880.5970, 21 CFR 880.6920, 21 CFR 880.6960.
Product codes that cite ISO 23908
46 FDA product codes cite ISO 23908, including BRZ, CAK, DZM, FMF, FMG.
- BRZ
- CAK
- DZM
- FMF Syringe, Piston
- FMG
- FMI Needle, Hypodermic, Single Lumen
- FOS
- FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- FPA Set, Administration, Intravascular
- FPB
- FPK
- FRN Pump, Infusion
- KYZ
- KZH
- LHI Set, I.V. Fluid Transfer
- LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- LJT
- LZF
- LZG Pump, Infusion, Insulin
- LZH
- MEA
- MEB
- MEG Syringe, Antistick
- MHC
- MHD
- MJF
- MMK Container, Sharps
- MRH
- MRZ
- NGT Saline, Vascular Access Flush
- NKK
- NKN
- NSC
- NZW
- NZX
- OBK
- ODI
- ODY
- OGQ
- OJA
- OKC
- OKE
- OMF
- ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- OPP
- OWL
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.