Recognized standard
8600-6 Second edition 2020-09
FDA recognition 9-130 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-130 |
|---|---|
| Designation | 8600-6 Second edition 2020-09 |
| Title | Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This document defines terms for endoscopes and endotherapy devices commonly used in the endoscopic area. This document does not define general medical terms or other general terms. This document does not define terms that should be defined in other ISO 8600 (all parts). |
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: