The dabl Educational Trust device equivalence procedure.
Manufacturers of blood pressure measuring devices that have previously been successfully validated for accuracy may make modifications to a device, which do not affect its measurement accuracy and should not require further validation. In this paper the procedure for manufacturers to declare the equivalence of a modified device with a device that has been validated earlier is described.
Atkins
Neil
N
dabl Educational Trust, Dublin, Ireland.
O'Brien
D001795:Blood Pressure Determination / Q000295:instrumentation / Q000379:methods*; D015924:Blood Pressure Monitors / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D020407:Internet; D015203:Reproducibility of Results