Recognized standard
8600-3 Second edition 2019-08
FDA recognition 9-123 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-123 |
|---|---|
| Designation | 8600-3 Second edition 2019-08 |
| Title | Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics. |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of ISO 8600 specifies requirements and recommends test methods for measuring the field of view and direction of view of endoscopes. |
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: