Recognized standard
8637-3 First Edition 2018-07
FDA recognition 9-141 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-141 |
|---|---|
| Designation | 8637-3 First Edition 2018-07 |
| Title | Extracorporeal systems for blood purification - Part 3: Plasmafilters |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 3 |
| Scope (excerpt) | This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been included. It specifies requirements for sterile, single-use plasmafilters, intended for use on… |
At a glance
- 1–9 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: