Recognized standard
60601-2-36 Edition 2.0 2014-04
FDA recognition 9-119 · IEC · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-119 |
|---|---|
| Designation | 60601-2-36 Edition 2.0 2014-04 |
| Title | Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy |
| Standards developer | International Electrotechnical Commission |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 201.3.206 including equipment for other medical applications of therapeutic extracorporeally induced focused PRESSURE PULSES,hereafter referred to as ME… |
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: