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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 034 Date of Entry 01/30/2014 
FR Recognition Number 12-266
Standard
IEC  61689 Edition 3.0 2013-02
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
Scope/Abstract
This International Standard is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating continuous or quasi-continuous wave ultrasound in the frequency range 0,5 MHz to 5 MHz.

This standard only relates to ultrasonic physiotherapy equipment employing a single plane non-focusing circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head.
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.
Transition Period
FDA recognition of IEC 61689 Edition 3.0 2013-02 [Rec# 12-266] will be superseded by recognition of IEC 61689 Edition 4.0 2022-03 [Rec# 12-376]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-266] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-266] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
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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