| IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy |
| Recognition Number | ObGyn/Gastroenterology/Urology |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 9-119 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | ObGyn/Gastroenterology/Urology |
| FDA Tech | Subha Maruvada FDA/OMPT/CDRH/OSEL/DAM/ 301-796-2524 subha.maruvada@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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 EQUIPMENT. The applicability of this particular standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging
and monitoring devices. Other devices, such as PATIENT treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other
applicable IEC standards.
| Regulation Number | Device Name | Device Class | Product Code |
| §876.5990 | Lithotriptor, Extracorporeal Shock-Wave, Urological | Class 2 | LNS |
| Guidance for Industry and for FDA Reviewers-Guidance for the Content of Premarket Notification [510(k)s] for Extracoporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, Issued August 2000. |