Table 2.

Summary of test procedure steps from the 81060‐4 draft

Procedure Step	Intention of the procedure step
Perform the clinical accuracy protocol described in ANSI/AAMI/ISO 81060‐2	Establishes the BP device's clinical accuracy on stable, resting patients
Download standardized set of noise files from the AAMI‐hosted noise library	Standardized noise files assure that the performance of different BP devices is evaluated equally.
Preload a noise file into the noise playback device	Set up the noise playback device
Connect the BP simulator equipment to the device under test as depicted in the 81060‐4 draft	Assure a standardized setup
Configure the BP simulator to one of the predetermined BP values	Assure a standardized set of BP simulations
Perform and record the device readings	Establish baseline performance with no noise present
Connect the BP simulator and noise playback device to the device under test as depicted in the 81060‐4 draft	Prepare to perform the same set of BP determinations with added artifact noise. Note: the BP simulation and noise playback functionality may be integrated into a single piece of test equipment.
Configure both the BP simulator and the noise playback simulator to one of the predetermined combinations	Assure a standardized set of BP + noise simulations
Perform and record the device readings	Measure the performance with noise present
Gather a set of device readings for each predetermined combination listed in the 81060‐4 draft	Assure a consistent set of noise artifact challenges. This set of challenges is intended to represent a realistic subset of the artifact noise spectrum.
Compare and analyze the groups of device readings according to the instructions and specifications detailed in 81060‐4 draft.	The results analysis will indicate the impact of artifact noise on the BP device reading accuracy and device behavior