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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 036 Date of Entry 07/09/2014 
FR Recognition Number 12-275
IEC  61161 Edition 3.0 2013-01
Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
IEC 61161:2013 specifies a method of determining the total emitted acoustic power of ultrasonic transducers based on the use of a radiation force balance; establishes general principles for the use of radiation force balances in which an obstacle (target) intercepts the sound field to be measured; establishes limitations of the radiation force method related to cavitation and temperature rise; establishes quantitative limitations of the radiation force method in relation to diverging and focused beams; provides information on estimating the acoustic power for diverging and focused beams using the radiation force method; and provides information on assessment of overall measurement uncertainties. This International Standard is applicable to the measurement of ultrasonic power up to 1 W based on the use of a radiation force balance in the frequency range from 0,5 MHz to 25 MHz; the measurement of ultrasonic power up to 20 W based on the use of a radiation force balance in the frequency range 0,75 MHz to 5 MHz; the measurement of total ultrasonic power in well-collimated, diverging and focused ultrasonic fields; and to the use of radiation force balances of the gravimetric type or force feedback type. This third edition cancels and replaces the second edition published in 2006. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
- whereas the second edition tacitly dealt with circular transducers only, the present edition as far as possible deals with both circular and rectangular transducers, including a number of symbols for rectangular transducers;
- attention is paid to focused cases and the influence of scanning has been added;
- the method of calibrating the radiation force balance now depends on whether the set-up is used as a primary or as secondary measurement tool;
- and Annex B (basic formulae) has been updated and in Annex C the buoyancy change method is mentioned (see also future IEC 62555).
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.1200 Ultrasound, Infusion, System Class 2 NUI
§870.1200 Catheter, Ultrasound, Intravascular Class 2 OBJ
§870.1200 Reprocessed Intravascular Ultrasound Catheter Class 2 OWQ
§878.4410 Wound Cleaner, Ultrasound Class 2 NRB
§878.4410 Ultrasound, Skin Permeation Class 2 NRJ
§890.5300 Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Class 2 IMI
§890.5300 Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Class 3 LXF
§890.5300 Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Class 2 PFW
§890.5860 Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat Class 2 IMG
§892.1570 Transducer, Ultrasonic, Diagnostic Class 2 ITX
§892.1570 Diagnostic Ultrasonic Transducer, Robotic Class 2 OQQ
N/A Applicator, Hyperthermia, Deep Heating, Ultrasound Class 3 LNB
N/A Ultrasound, Hyperthermia, Cancer Treatment Class 3 LSY
N/A Automated Breast Ultrasound Class 3 PAA
Relevant FDA Guidance and/or Supportive Publications*
FDA Diagnostic Ultrasound Guidance, ¿Information for Manufacturers Seeking Marketing Clearance of
Diagnostic Ultrasound Systems and Transducers¿. Document issued on: September 9, 2008

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.