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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 9-119
Standard(Included in ASCA pilot)
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
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.5990 Lithotriptor, Extracorporeal Shock-Wave, Urological Class 2 LNS
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. 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.
FDA Technical Contact
 Subha Maruvada
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2524
  subha.maruvada@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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