Recognized standard
8637-2 First Edition 2018-07 8637-2:2018
FDA recognition 9-140 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-140 |
|---|---|
| Designation | 8637-2 First Edition 2018-07 8637-2:2018 |
| Title | Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits. This… |
At a glance
- 10–99 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: