BAIJIAN - Third party testing organization
This part of GB/T 21417 specifies the terms、 definitions、 requirements、 test methods、 inspection rules and markings、 user manual、 packaging、 transportation、 and storage of ear cavity medical infrared thermometers. This section is applicable to ear cavity type medical infrared thermometers (hereinafter referred to as thermometers) that display the temperature of a certain part of the body through infrared radiation exchange and appropriate correction values between various measurements and the ear cavity of sensitive objects. This thermometer displays the body temperature of the subject through the thermal radiation from the Zhouliang ear cavity. 2 Normative References: The clauses in the following documents are referred to as clauses in this part of GB/T 21417. For dated reference documents、 all subsequent amendments (excluding corrected content) or revisions shall not apply to this section. However、 all parties who have reached an agreement based on this section shall investigate whether new versions of these documents can be used. The new version of any referenced document with a specific date applies to this section. GB/T 191-2000 Packaging - Graphical Symbols for Remote Storage (eqv 1S0 780.1997) GB/T 2829-2002 Sampling Procedures and Tables for Periodic Inspection (Applicable to the Inspection of Process Stability) GB 9706.1 Medical Electrical Equipment - Part 1: Requirements for Safe Liquor Use (GB 9706 1-2007、 IEC 60601-1 1988、 IDT) GB 9969.1 General Principles of Industrial Product User Manual GB/T 14710-1993 Environmental Requirements and Test Methods for Medical Electrical Equipment GB/T 16886.1-2001 Biological Evaluation of Medical Devices Part 1、 Evaluation and Testing (idt 1S0 1993-1.1997) 3 Terms and Definitions The following terms and definitions apply to this part of GB/T 21417. 3.1 Ear cavity infrared thermometer is a photoelectric instrument used to measure the temperature of the ear cavity of the tested object in a non-contact and infrared manner. 3.2 Black body value of the black body accurately knows the hole wall temperature and a hole shaped infrared radiation reference source with an approximate emissivity of 1.0 at any opening of the hole. 3.3 Body temperature The temperature measured at a specific part of the human body (such as the pulmonary artery、 bladder、 ear cavity、 oral cavity、 rectum、 or limb fossa). 3.4 Clinical accuracy The degree to which a thermometer reading is close to the temperature of a specific part of the body (measured by a standard thermometer) it indicates to represent. 3.5 Clinical bias Clinical bias and its standard deviation represent the average difference between the temperature estimated using the thermometer in the test and the temperature of the subject measured using the standard thermometer
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