Recognized standard
20696 First edition 2018-06; Corrected 2019-12
FDA recognition 9-143 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-143 |
|---|---|
| Designation | 20696 First edition 2018-06; Corrected 2019-12 |
| Title | Sterile urethral catheters for single use |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | May 29, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon. This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also… |
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: