| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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036
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Date of Entry 07/09/2014
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FR Recognition Number
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12-275
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| Standard | |
IEC 61161 Edition 3.0 2013-01
Ultrasonics -- Power measurement -- Radiation force balances and performance requirements |
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Scope/AbstractIEC 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). |
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| Extent of Recognition
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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
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OBJ
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| §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
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
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