| IEC 61161 Edition 3.0 2013-01 Ultrasonics -- Power measurement -- Radiation force balances and performance requirements |
| Recognition Date | 2014-07-09 |
| Recognition List | 036 |
| Recognition Number | 12-275 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Radiology |
| FDA Tech | Subha Maruvada FDA/OMPT/CDRH/OSEL/DAM/ 301-796-2524 subha.maruvada@fda.hhs.gov |
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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).
| Regulation Number | Device Name | Device Class | Product Code |
| §892.1570 | Diagnostic Ultrasonic Transducer, Robotic | Class 2 | OQQ |
| §892.1570 | Transducer, Ultrasonic, Diagnostic | Class 2 | ITX |
| §890.5860 | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | Class 2 | IMG |
| §878.4410 | Ultrasound, Skin Permeation | Class 2 | NRJ |
| §878.4410 | Wound Cleaner, Ultrasound | Class 2 | NRB |
| §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 |
| §890.5300 | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | Class 2 | IMI |
| §870.1200 | Catheter, Ultrasound, Intravascular | Class 2 | OBJ |
| §870.1200 | Reprocessed Intravascular Ultrasound Catheter | Class 2 | OWQ |
| §870.1200 | Ultrasound, Infusion, System | Class 2 | NUI |
| Unclassified | Applicator, Hyperthermia, Deep Heating, Ultrasound | Class 3 | LNB |
| Unclassified | Automated Breast Ultrasound | Class 3 | PAA |
| Unclassified | Ultrasound, Hyperthermia, Cancer Treatment | Class 3 | LSY |
| FDA Diagnostic Ultrasound Guidance, ¿Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers¿. Document issued on: September 9, 2008 |