DIN Standards Committee Optics and Precision Mechanics
Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024); German and English version prEN ISO 12487:2024
Abstract
This document specifies the requirements and methods for the clinical investigation of ME equipment used to measure the body temperature in indirect measurement mode. This document covers both intermittently and continuously measuring clinical thermometers. This document is not intended for clinical thermometers measuring the body temperature in direct measurement mode. NOTE 1 For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient. NOTE 2 For clinical thermometers with claimed measurement time shorter than 60 seconds (for methods such as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement) are treated as predictive type thermometers and fall under the scope of this standard. This document specifies additional disclosure requirements. This document is not applicable to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.
Begin
2023-03-20
WI
00205392
Planned document number
DIN EN ISO 12487
Project number
02703397
Responsible national committee
NA 027-06-02 AA - Clinical thermometer
Responsible european committee
CEN/TC 205 - Non-active medical devices
Responsible international committee
ISO/TC 121/SC 3/JWG 8 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG: Clinical Thermometers
draft standard
Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024); German and English version prEN ISO 12487:2024
2025-01
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