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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 051 Date of Entry 01/14/2019 
FR Recognition Number 3-44
ANSI AAMI  BP22:1994 (R2016)
Blood pressure transducers
This standard applies to pressure transducers, including cables, used to measure blood pressure through
catheters or direct vascular puncture. Physiological measurements other than blood pressure may be taken
with this transducer, although the requirements and tests of this standard were developed and designed with
blood pressure measurement as the intended application of the device. Even though this standard addresses
the safety and efficacy of the transducer for measurement of blood pressure, care should be exercised to
ensure the compatibility of the particular transducer and blood pressure monitor.
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
§870.1110 Computer, Blood-Pressure Class 2 DSK
§870.2060 Amplifier And Signal Conditioner, Transducer Signal Class 2 DRQ
§870.2850 Transducer, Blood-Pressure, Extravascular Class 2 DRS
§870.2870 Transducer, Pressure, Catheter Tip Class 2 DXO
Relevant FDA Guidance and/or Supportive Publications*
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
 Charles Ho
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.