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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 036 Date of Entry 07/09/2014 
FR Recognition Number 12-279
Standard
IEC  62127-03 Edition 1.1 2013-05
Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
Scope/Abstract
IEC 62127-3:2007 specifies relevant hydrophone characteristics. This standard is applicable to hydrophones employing piezoelectric sensor elements, designed to measure the pulsed and continuous wave ultrasonic fields generated by ultrasonic equipment; hydrophones used for measurements made in water; and hydrophones with or without an associated 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.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of IEC 62127-03 Edition 1.1 2013-05 [Rec# 12-279] will be superseded by recognition of IEC 62127-03 Edition 2.0 2022-12 [Rec# 12-377]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-279] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-279] will not be accepted.
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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