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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 064 Date of Entry 05/26/2025 
FR Recognition Number 12-379
Standard
IEC  62127-2 Edition 2.0 2025-01
Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
Scope/Abstract
This part of IEC 62127 specifies:
- absolute hydrophone calibration methods;
- relative (comparative) hydrophone calibration methods.

Recommendations and references to accepted literature are made for the various relative andabsolute calibration methods in the frequency range covered by this document.
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.
Transition Period
FDA recognition of IEC 62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION [Rec# 12-291] will be superseded by recognition of IEC 62127-2 Edition 2.0 2025-01 [Rec# 12-379]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-291] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-291] 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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