Recognized standard
8600-5 Second Edition 2020-10
FDA recognition 9-131 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-131 |
|---|---|
| Designation | 8600-5 Second Edition 2020-10 |
| Title | Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | This document applies to rigid endoscopes designed for use in the practice of medicine. Endoscopes having a fibre-optic or opto-electronic imaging system are excluded. It specifies a test method for determining the optical resolution of endoscopes. This document provides a measurement method for… |
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: