Recognized standard
7439:2023
FDA recognition 9-150 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-150 |
|---|---|
| Designation | 7439:2023 |
| Title | Copper-bearing contraceptive intrauterine devices - Requirements and tests |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 3 |
| Scope (excerpt) | This document specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens or other medicinal products. |
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: