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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Entry 08/14/2015 
FR Recognition Number 12-291
Standard
IEC  62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
Scope/Abstract
IEC 62127-2:2007+A1:2013+A2:2017 specifies absolute hydrophone calibration methods and relative (comparative) hydrophone calibration methods. This standard is applicable to:
- hydrophones used for measurements made in water and in the ultrasonic frequency range up to 40 MHz;
- hydrophones employing circular piezoelectric sensor elements, designed to measure the pulsed wave and continuous wave ultrasonic fields generated by ultrasonic equipment;
- and hydrophones with or without a hydrophone pre-amplifier. 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. The contents of the corrigendum of August 2008 have been included in this copy.
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
§892.1550 System, Imaging, Pulsed Doppler, Ultrasonic Class 2 IYN
§892.1560 System, Imaging, Pulsed Echo, Ultrasonic Class 2 IYO
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

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
 Keith Wear
  FDA/OC/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
*These are provided as examples and others may be applicable.
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