FDA-recognized standard · Cardiovascular
AAMI TIR42: Evaluation of Particulates Associated with Vascular Medical Devices
Yes. FDA recognizes AAMI TIR42:2021 as recognition 3-172, entered 2021-12-20.
Recognized editions of AAMI TIR42
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 3-172 | AAMI TIR42:2021 | 2021-12-20 | Complete | — |
Regulations
FDA lists these classification regulations against AAMI TIR42: 21 CFR 870.1200, 21 CFR 870.1210, 21 CFR 870.1220, 21 CFR 870.1250, 21 CFR 870.1280, 21 CFR 870.1330, 21 CFR 870.1340, 21 CFR 870.1390, 21 CFR 870.5100, 21 CFR 870.5175, 21 CFR 876.5540.
Product codes that cite AAMI TIR42
35 FDA product codes cite AAMI TIR42, including DQO, DQX, DQY, KRA, LFJ.
- DQO Catheter, Intravascular, Diagnostic
- DQX Wire, Guide, Catheter
- DQY Catheter, Percutaneous
- KRA Catheter, Continuous Flush
- LFJ
- LFK
- LIT Catheter, Angioplasty, Peripheral, Transluminal
- LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
- MAF
- MIH
- MLV
- MPB
- MSD Catheter, Hemodialysis, Implanted
- NIE
- NIF
- NIM
- NIN
- NIO
- NIP
- NIQ
- NKS
- NLG
- NLH Catheter, Recording, Electrode, Reprocessed
- NMK
- NQJ
- NWX
- NYU
- ONU
- OWQ Reprocessed Intravascular Ultrasound Catheter
- PKI
- PNE
- PNO Catheter, Percutaneous, Cutting/Scoring
- PRC
- QAN
- QLZ
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.