FDA-recognized standard · Dental/ENT
ISO 13402: Surgical and dental hand instruments -- Determination of resistance against autoclaving corrosion and thermal exposure
Yes. FDA recognizes ISO 13402 First edition 1995-08-01 as recognition 4-320, entered 2023-12-18.
Recognized editions of ISO 13402
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 4-320 | ISO 13402 First edition 1995-08-01 | 2023-12-18 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 13402: 21 CFR 878.4820, 21 CFR 888.3050, 21 CFR 888.4300, 21 CFR 888.4540, 21 CFR 888.4800.
Product codes that cite ISO 13402
46 FDA product codes cite ISO 13402, including HRR, HRT, HTJ, HTO, HTP.
- HRR
- HRT
- HTJ
- HTO
- HTP
- HTQ
- HTS
- HTT
- HTW
- HTX
- HWA
- HWB
- HWD
- HWI
- HWJ
- HWK
- HWL
- HWN
- HWO
- HWP
- HWQ
- HWR
- HWT
- HWW
- HWX
- HXB
- HXC
- HXG
- HXI
- HXJ
- HXK
- HXN
- HXO
- HXP
- HXQ
- HXS
- HXW
- HXX
- HXY
- HXZ
- KIL
- LXH
- LXI
- LYP
- LYQ
- LYS
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.