The objective of the intercomparison is to determine agreement of blackbodies and procedures in calibration of IRETs among European national laboratories. The comparison was initiated to solve the problem of assuring proper traceability for IRETs. IRET is an instrument, which measures temperature of a human body. Essential requirement is related to accuracy. There are several standards in the world, which describe requirements for IRETs. In EU this is the standard EN 12470-5, which is a harmonised standard and supports the Medical Device Directive (MDD). Other standards are ASTM standard, Designation E 1965 - 98 and the draft of Japan Industrial Standard. The basic requirement for accuracy in EN 12470-5 is that the maximum permissible error of IRET is ±0,2 °C in the range from 35,5 °C to 42,0 °C. To verify the accuracy a suitable blackbody is needed. An example of a blackbody is presented in Annex C of the standard EN 12470-5.
The pilot laboratory will provide the bath with the "EN-type" of a blackbody and the reference IRET. The bath is owned by the manufacturer Laboratorijska oprema Kambi?. Expenses related to renting of baths are covered by the pilot laboratory. Expenses related to transport to the next laboratory are covered by a particular laboratory. The IRET and the bath will be calibrated in the pilot laboratory before and after comparison measurements in participating laboratories.
Each participant laboratory will calibrate at least the reference IRET (laboratory may calibrate also their own IRET, if they have one) against the travelling blackbody and against the laboratory.
The technical protocol can be downloaded here>>
Final Report 2011-03-11
The comparison has been completed and the report can be downloaded here>>