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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 12-277
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
Transition Period
FDA recognition of IEC 62127-1 Edition 1.1 2013-02 [Rec# 12-277] will be superseded by recognition of IEC 62127-1 Edition 2.0 2022-03 [Rec# 12-343]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-277] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 12-277] 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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