Recognized standard
60601-2-18: Edition 3.0 2009-08
FDA recognition 9-114 · IEC · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-114 |
|---|---|
| Designation | 60601-2-18: Edition 3.0 2009-08 |
| Title | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| Standards developer | International Electrotechnical Commission |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC… |
At a glance
- 1–9 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: