Recognized standard
8637-1 First edition 2017-11 8637-1:2017
FDA recognition 9-118 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-118 |
|---|---|
| Designation | 8637-1 First edition 2017-11 8637-1:2017 |
| Title | Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans. Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified… |
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: