Recognized standard
8600-1 Fourth Edition 2015-10-15
FDA recognition 9-110 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-110 |
|---|---|
| Designation | 8600-1 Fourth Edition 2015-10-15 |
| Title | Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Apr 4, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 8600-1:2015 gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine. |
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: