Recognized standard
20697 First edition 2018-06; Corrected 2018-09
FDA recognition 9-144 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-144 |
|---|---|
| Designation | 20697 First edition 2018-06; Corrected 2018-09 |
| Title | Sterile drainage catheters and accessory devices for single use |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the… |
At a glance
- None 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: