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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Recognition 07/09/2014 
FR Recognition Number 12-277
Standard
IEC 62127-1 Edition 1.1 2013-02
Ultrasonics -- Hydrophones -- Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz
Scope/Abstract
EC 62127-1:2007+A1:2013 specifies methods of use of calibrated hydrophones for the measurement in liquids of acoustic fields generated by ultrasonic medical equipment operating in the frequency range up to 40 MHz. The objectives of this standard are:

- to define a group of acoustic parameters that can be measured on a physically sound basis;

- to define a second group of parameters that can be derived under certain assumptions from these measurements, and called derived intensity parameters;

- to define a measurement procedure that may be used for the determination of acoustic pressure parameters;

- to define the conditions under which the measurements of acoustic parameters can be made in the frequency range up to 40 MHz using calibrated hydrophones;

- and to define procedures for correcting, for limitations caused by the use of hydrophones with finite bandwidth and finite active element . IEC 62127-1, IEC 62127-2 and IEC 62127-3 are being published simultaneously. Together these cancel and replace IEC 60866:1987, IEC 61101:1991, IEC 61102:1991, IEC 61220:1993 and IEC 62092:2001.

Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§892.1560 System, Imaging, Pulsed Echo, Ultrasonic Class 2 IYO
§892.1550 System, Imaging, Pulsed Doppler, Ultrasonic Class 2 IYN
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. Document issued on: September 9, 2008
FDA Technical Contact
 Keith Wear
  FDA/OMPT/CDRH/OSEL/DAM/
  301-796-2538
  keith.wear@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
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