FDA-recognized standard · Materials
ISO 7153-1: Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)]
Yes. FDA recognizes ISO 7153-1 Second edition 1991-04-01 as recognition 8-344, entered 2014-01-30.
Recognized editions of ISO 7153-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 8-344 | ISO 7153-1 Second edition 1991-04-01 | 2014-01-30 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 7153-1: 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 7153-1
46 FDA product codes cite ISO 7153-1, 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.