BS EN 80601-2-59:2009 Medical electrical equipment. Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
BS EN 80601 is the standard that has been prepared under a mandate given to cenelec by the European commission and the European free trade association. Within its scope the standard covers all relevant essential requirements of the EC Directive 93/42/EEC with the exception of essential requirements 3 and 10.1.
Compliance with this standard provides one means of conformity with the specified essential requirements of the Medical Devices Directive concerned.
The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for human febrile temperature screening.
This part of BS EN 80601 describes the ME equipment that uses infrared technology to detect naturally emitted heat at the skin surface of the face. Such ME equipment can be useful at ports-ofentry or ports-of-exit and the entrances to buildings under indoor environmental conditions to separate febrile from afebrile individuals to help prevent the spread of communicable diseases. Care can be needed when evaluating individuals under changing environmental conditions, but the inner canthus of the eye has been demonstrated to be a robust measurement site and is supplied by the internal carotid artery.
A body core temperature of 38 °c or above was used as the criterion to restrict travelling during the SARS (severe acute respiratory syndrome) epidemic (april 2003). The US center for disease control advises that SARS typically begins with a temperature above 38 °c, which is 1 °c higher than normal human body core temperature which averages around 37 °c. It is hard to give an accurate assessment of how many people were checked by infrared temperature measurements in China during the SARS epidemic. There is official chinese government data indicating that during a two-month period in the spring of 2003, 30 million travelers were screened in China. From this cohort, 9 292 travelers with elevated temperature were detected and 38 were suspected of being SARS carriers. SARS was diagnosed in 21 of these cases. All elevated temperatures were confirmed using traditional clinical temperature measurements of body temperature. Although it is hard to determine the human body's core temperature accurately by infrared measurement of skin temperature, it is a potential method for screening for elevated temperature values.
This part of BS EN 80601 amends and supplements IEC 60601-1: Medical electrical equipment. General requirements for safety and essential performance.
The requirements are followed by specifications for the relevant tests. A "general guidance and rationale" section giving some explanatory notes, where appropriate, about the more important requirements is included in annex aa. It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the requirements of this standard.
BS EN 80601-2-59 applies to the basic safety and essential performance of screening thermographs intended to be used for the individual non-invasive febrile temperature screening of humans under indoor environmental conditions, hereafter referred to as ME equipment. This international standard sets laboratory characterization test limits for the screening thermograph.
Contents of BS EN 80601-2-59 include:
- Scope, object and related standards
- Normative references
- Terms and general requirements
- General requirements for testing of ME equipment
- Classification of ME equipment and ME systems
- ME equipment identification, marking and documents
- Protection against electrical hazards from ME equipment
- Protection against mechanical hazards of ME equipment and me systems
- Protection against unwanted and excessive radiation hazards
- Protection against excessive temperatures and other hazards
- Accuracy of controls and instruments and protection against hazardous outputs
- Hazardous situations and fault conditions
- Programmable electrical medical systems (PEMS)
- Construction of ME equipment
- ME systems
- Electromagnetic compatibility of ME equipment and ME systems
- Laboratory accuracy of a screening thermograph4
- Screening thermograph alarm conditions
- Guide to marking and labelling requirements for ME equipment and ME systems
- Particular guidance and rationale
- Calibration source
- Reference to the essential principles
- Bibliography
- Index of defined terms used in this particular standard
- Relative drift of 4 detectors as a function of time
- Distributed essential performance requirements
- Accompanying documents, instructions for use of a screening thermograph
- Accompanying documents, technical description of a screening thermograph
- Example of relevant uncertainty terms for a screening thermograph
- Correspondence between this particular standard and the essential principles
