Recognized standard
16037 First edition 2002-05-15 (Amendment 1 2011-02-15)
FDA recognition 9-86 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-86 |
|---|---|
| Designation | 16037 First edition 2002-05-15 (Amendment 1 2011-02-15) |
| Title | Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2011)] |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard is intended as a guideline for clinical researchers working with condoms. It suggests a series of laboratory tests to be conducted on the products to be used in any clinical investigation, so that it will be easier to relate the clinical results to the design and quality… |
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: