scope:

General

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.

Inclusions

Included within the scope of this standard are safety and performance requirements for transducers, including cables, designed for blood pressure measurements through an indwelling catheter or direct puncture and disclosure requirements to permit the user to determine compatibility between the transducer and blood pressure monitor.

Exclusions

Excluded from the scope of this standard are transducers designed specifically for the measurement of other physiological parameters. This standard does not address operating procedures for the transducer or monitor. Therefore, it is necessary to consult appropriate instruction manuals to set up, balance, and calibrate the system properly.