Recognized standard
8600-4 Third Edition 2023-01
FDA recognition 9-146 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-146 |
|---|---|
| Designation | 8600-4 Third Edition 2023-01 |
| Title | Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion |
| 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 a method of measurement of the maximum insertion portion width of medical endoscopes and certain endoscopic accessories. |
At a glance
- 10–99 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: