DIN EN ISO 80601-2-56:2013-02

Clinical thermometers are designed and fabricated as portable, transit-operable, or hand-held ME equipment for home healthcare and clinical use, or as parts of the stationary ME equipment. The requirements and test procedures of this standard have been developed with the intent to make them applicable to a broad range of present and future clinical thermometer technologies, while assuring that every clinical thermometer that conforms to this standard provides an acceptable degree of diagnostic value and acceptable risk. There are several risks associated with use of this type of ME equipment. An obvious risk is a misdiagnosis - for example, a false negative or false positive detection of a fever which leads to a wrong treatment of a patient. Another risk is a possible injury of a patient or operator by the clinical thermometer or its components. Risk control is the main purpose of this standard which describes the requirements and procedures that assure acceptable levels of clinical and functionality, which should be maintained over the expected service life of the clinical thermometer. This standard is a product standard which is directed at manufacturers and test institutes. The committee responsible for this standard is NA 027-02-18 AA "Klinische Fieberthermometer" ("Clinical thermometers") at DIN.