FDA-recognized standard · Cardiovascular
ISO 11658: Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
Yes. FDA recognizes ISO 11658 First edition 2012-05-15 as recognition 3-183, entered 2022-12-19.
Recognized editions of ISO 11658
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 3-183 | ISO 11658 First edition 2012-05-15 also ANSI AAMI ISO 11658: 2012 | 2022-12-19 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 11658: 21 CFR 870.1250, 21 CFR 870.4100, 21 CFR 870.4210, 21 CFR 870.4230, 21 CFR 870.4240, 21 CFR 870.4260, 21 CFR 870.4270, 21 CFR 870.4350, 21 CFR 870.4360, 21 CFR 870.4390, 21 CFR 870.4400, 21 CFR 880.5200, 21 CFR 880.5970.
Product codes that cite ISO 11658
24 FDA product codes cite ISO 11658, including BYS, DQY, DTM, DTN, DTP.
- BYS
- DQY Catheter, Percutaneous
- DTM
- DTN
- DTP
- DTR Heat-Exchanger, Cardiopulmonary Bypass
- DTZ Oxygenator, Cardiopulmonary Bypass
- DWE
- DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- FOS
- FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- JOD
- KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- LIT Catheter, Angioplasty, Peripheral, Transluminal
- LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- NGT Saline, Vascular Access Flush
- NZW
- NZX
- OWL
- PEF
- PEZ
- PZS
- QHW
- QJZ
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.