Testing of clinical thermometers.
The results of a study undertaken to indicate the degree to which clinical thermometers conform to the requirements of voluntary standard ANSI/ASTM E 667-79 are presented. This study was one of several performed by the Food and Drug Administration to determine the applicability of voluntary medical device standards, with respect to the feasibility of their test methods and the reasonableness of their application to currently marketed devices. 149 clinical thermometers (maximum self-registering, mercury-in-glass) from eight domestic manufacturers were tested following the requirements and test methods specified in ANSI/ASTM E 667-79. 42% of the fever and 100% of the basal thermometer samples tested failed to meet one or more of the requirements of the standard. However, if the requirements for temperature scale graduation marks and identification are excluded, the failure rate is reduced to 14% of the fever and 8% of the basal thermometers. Those that did fail the accuracy requirement were only .1F degree out of compliance.
D005069:Evaluation Studies as Topic; D013673:Technology Assessment, Biomedical; D013821:Thermometers / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration