EN 80601-2-59
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DIN EN 80601-2-59 |
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| Area | Medical technology |
| title | Medical electrical equipment - Part 2-59: Particular requirements for basic safety including the essential performance characteristics of thermal imaging cameras for screening people for fever |
| Latest edition | 7.2010 |
| ISO | IEC 80601-2-59: 2008 + Corrigendum 2009 |
The EN 80601-2-59 titled "Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of thermal imaging cameras for screening human febrile" is part of the series 60601 EN (EN 60601 series is currently transferred to the EN 80601 series).
The DIN standard DIN EN 80601-2-59 is published by the German Institute for Standardization .
Within the framework of the VDE standards, the standard is classified as VDE 0750-2-59 , see DIN-VDE standards part 7 .
This supplementary standard regulates general requirements for the safety, tests and guidelines of thermal imaging cameras for screening people for fever. The purpose is to describe the features of basic safety, the essential performance features and tests and also to provide instructions for their application.
validity
- The final version of the standard is to be used in accordance with the 3rd edition of DIN EN 60601-1 .
scope of application
This International Standard applies to the basic safety and the essential performance characteristics of thermal imaging cameras for series examinations, which are intended for the non-invasive series examination of groups of people for elevated temperature ( fever ) under indoor ambient conditions and are hereinafter referred to as ME device and ME system.
Thermal imaging cameras for series examinations use infrared technology to detect the naturally radiated heat on the surface of the skin on the front of the skull (face) . Thermal imaging cameras for screening were used at entry points and building entrances with the aim of distinguishing people with a fever from those without fever in order to prevent the spread of infectious diseases.
The performance requirements specified in this document apply to thermal imaging cameras for series examinations for the general operation of temperature series examinations. These specifications set limits for the characterization laboratory testing of the thermal imaging cameras for screening and require the determination and disclosure of the evaluation results, including the clinical test of the performance of the human temperature screening, which corresponds to the intended application.
A thermal imaging camera for series examinations records the temperature of the human face and allows the operator to quantitatively determine and display the skin temperature profile. Since the skin temperature depends to a large extent on the blood perfusion (circulation) of the skin and the environmental conditions, thermal imaging cameras must be used for screening in a stable environment with minimal external environmental disturbance in order to meet the requirements for the essential performance characteristics.
A thermal imaging camera for screening is intended for screening and recognizing people with increased skin temperatures. After ascertaining an increased skin temperature, the body temperature must be measured with a clinical thermometer (see IEC / ISO 80100-1).
extra information
- This standard is new and has no previous standard.
The following changed requirements are contained in EN 80601-2-59 (extract):
- Environmental conditions
- accuracy