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DSF/IEC 62556

2012 Edition, 2012

Complete Document

Surgical systems - Specification and measurement of field parameters for High Intensity Therapeutic Ultrasound (HITU) transducers and systems

Includes all amendments and changes through Draft , 2012

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Product Details:

  • Revision: 2012 Edition, 2012
  • Published Date: January 2012
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Dansk Standardiseringsrad (DS)
  • Page Count: 91
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

This Technical Specification is relevant to High Intensity Therapeutic Ultrasound (HITU) devices, specifying: ? relevant parameters for quantifying the field ? measurement methods at relatively low output levels and methodology for extrapolating these to higher therapeutic level fields ? consideration of sidelobes and pre-focal maxima ? parameters relevant to scanning transducers and multiple sources This Technical Specification is intended to support the ultrasonic measurement demands given in the IEC 60601-2-62 standard. These specifications would have use in quality assurance, safety testing, and the standardization of communications regarding the clinical performance of HITU systems. Where possible, this document incorporates specifications from other related standards1. This Technical Specification does not apply to the following types of devices, which are covered by other standards: Lithotripters: IEC 61846: Ultrasonics - Pressure pulse lithotripters - Characteristics of fields Surgical Equipment: IEC 61847: Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Physiotherapy Devices: IEC 61689: Ultrasonics - Physiotherapy systems - Performance requirements and methods of measurement in the frequency range 0,5 MHz to 5 MHz - NOTE 1 Throughout this Technical Specification SI units are used. In the specification of certain parameters, such as beam areas and intensities, it may be convenient to use decimal multiples or sub-multiples. For example, beam-area may be specified in cm2 and intensities in W/cm2 or mW/cm2.