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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 031 Date of Entry 08/06/2013 
FR Recognition Number 12-205
Standard(Included in ASCA pilot)
IEC 60601-2-5: Edition 3.0 2009-07
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
Scope/Abstract
This Particular Standard specifies the requirements for safety of ULTRASONIC PHYSIOTHERAPY EQUIPMENT used in medical practice, as defined in 2.1.101.

This Particular Standard does not apply to:

- EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry);

- EQUIPMENT in which focused ULTRASOUND pulse waves are used to destroy conglomerates such as stones in the kidneys or the bladder (lithotrites) (for information refer to IEC 60601-2-36);

- ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ULTRASOUND pulse waves are used.
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)*
CFR 1050.10 Performance Standards for Sonic, Infrasonic and Ultrasonic Radiation-Emitting Products. Ultrasonic Therapy Products
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

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
  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)
Radiology
*These are provided as examples and others may be applicable.
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