The dabl Educational Trust device equivalence procedure

Blood Press Monit. 2007 Aug;12(4):246-9. doi: 10.1097/mbp.0b013e32809efa27.

Abstract

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.

MeSH terms

  • Blood Pressure Determination / instrumentation
  • Blood Pressure Determination / methods*
  • Blood Pressure Monitors / standards*
  • Guidelines as Topic
  • Humans
  • Internet
  • Reproducibility of Results