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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 020 Date of Entry 09/09/2008 
FR Recognition Number 9-7
IEC  61846 First edition 1998-04
Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
This International Standard is applicable to
- lithotripsy equipment using extracorporeally induced pressure waves;
- lithotripsy equipment producing focused mechanical energy.
This International Standard does not apply to percutaneous and laser lithotripsy equipment.
This International Standard specifies
- measurable parameters which could be used in the declaration of the acoustic output of
extracorporeal lithotripsy equipment,
- methods of measurement and characterization of the pressure field generated by
lithotripsy equipment.
Extent of Recognition
Complete standard
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*
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.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Subha Maruvada
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.