DIN EN ISO 80601-2-56
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
|Publication Date:||1 February 2013|
|ICS Code (Temperature-measuring instruments):||17.200.20|
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This standard specifies the general and technical requirements for electrical CLINICAL THERMOMETERS. This standard applies to all electrical CLINICAL THERMOMETERS that are used for measuring the body temperature of PATIENTS.
CLINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME SYSTEMS. This standard does not apply to auxiliary equipment.
ME EQUIPMENT that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of this standard.
EXAMPLE 1 Swan-Ganz thermodilution determination of cardiac output is not in the scope of this standard.
EXAMPLE 2 A Foley catheter that includes a temperature PROBE is in the scope of this standard.
EXAMPLE 3 PATIENT heating ME EQUIPMENT that includes a skin temperature measurement such as infant incubators, heating blankets, heating pads and heating mattresses are not in the scope of this standard, unless they indicate a temperature of a REFERENCE BODY SITE in which they are in the scope of this standard.
Requirements for ME EQUIPMENT intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601-2-59:2008 and such ME EQUIPMENT is not covered by this standard.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in IEC 60601-1:2005, 7.2.13 and 8.4.1.
NOTE Additional information can be found in IEC 60601-1:2005, 4.2.