IEC 62359:2017 PDF

Scope: 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 non- thermal effects. NOTE 1 In Clause 3 of this standard, SI units are used (per ISO/IEC Directives, Part 2, ed. 5, Annex I b) in the Notes below definitions of certain parameters, such as beam areas and intensities; it may be convenient to use decimal multiples or submultiples in practice. Users must take care of decimal prefixes used in combination with the units when using and calculating numerical data. For example, beam area may be specified in cm2 and intensities in W/cm2 or mW/cm2 . NOTE 2 Underlying calculations have been done from 0,25 MHz to 15 MHz for MI and 0,5 MHz to 15 MHz for TI. NOTE 3 The thermal indices are steady state estimates based on the acoustic output power required to produce a 1°C temperature rise in tissue conforming to the "homogeneous tissue 0,3 dBcm-1 MHz-1 attenuation model".

IEC 62359:2017 Referenced Document

IEC 60601-2-37:2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 61157:2007 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
IEC 61161:2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements
IEC 61828:2001 Ultrasonics - Focusing Transducers - Definitions and Measurement Methods for the Transmitted Fields (Edition 1.0)
IEC 62127-1:2007 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz
IEC 62127-2:2007 Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields up to 40 MHz
IEC 62127-3:2007 Ultrasonics - Hydrophones - Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz

2017 IEC 62359:2010/AMD1:2017 Amendment 1 - Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
2017 IEC 62359:2017 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
2011 IEC 62359:2010/COR1:2011 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
2010 IEC 62359:2010 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
2005 IEC 62359:2005 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields