| ANSI AAMI BP22:1994 (R2016) Blood pressure transducers |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 3-44 |
| Extent | Complete standard |
| STG | Cardiovascular |
| FDA Tech | Charles Ho FDA/OMPT/CDRH/ODE/DCD/CDDB/ 301-796-6320 charles.ho@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §870.2870 | Transducer, Pressure, Catheter Tip | Class 2 | DXO |
| §870.2850 | Transducer, Blood-Pressure, Extravascular | Class 2 | DRS |
| §870.2060 | Amplifier And Signal Conditioner, Transducer Signal | Class 2 | DRQ |
| §870.1110 | Computer, Blood-Pressure | Class 2 | DSK |
| There is no relevant guidance developed at this time. |