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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 049 Date of Recognition 06/07/2018 
FR Recognition Number 12-316
IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION
Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
This International standard is applicable to medical diagnostic ultrasound fields.

This standard establishes

- parameters related to thermal and non-thermal exposure aspects of diagnostic ultrasonic fields;

- methods for the determination of an exposure parameter relating to temperature rise in theoretical tissue-equivalent models, resulting from absorption of ultrasound;

- methods for the determination of an exposure parameter appropriate to certain nonthermal effects.

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)
Regulation Number Device Name Device Class Product Code
§892.1570 Media, Coupling, Ultrasound Class 2 MUI
§892.1570 Transducer, Ultrasonic, Diagnostic Class 2 ITX
§892.1560 System, Imaging, Pulsed Echo, Ultrasonic Class 2 IYO
§892.1550 System, Imaging, Pulsed Doppler, Ultrasonic Class 2 IYN
§892.1540 Monitor, Ultrasonic, Nonfetal Class 2 JAF
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA Staff: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Issued September 2008.
FDA Technical Contact
 Keith Wear
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)