Recognized standard
29943-1 First edition 2017-07.
FDA recognition 9-115 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-115 |
|---|---|
| Designation | 29943-1 First edition 2017-07. |
| Title | Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 29943-1:2017 is intended to help in the design, execution, analysis and interpretation of clinical function studies conducted in accordance with the requirements of ISO 23409 for male synthetic condoms. These clinical studies compare the performance of a new male condom to an established male… |
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: