BS PD ISO TR 13154-2017 Medical electrical equipment Deployment implementation and operational guidelines for identifying febrile humans using a screening thermograph《医疗电气设备 筛选温度计用.pdf

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1、Medical electrical equipment Deployment, implementation and operational guidelines foridentifying febrile humans using a screening thermographPD ISO/TR 13154:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis Published Document is the UK implem

2、entation of ISO/TR 13154:2017.It supersedes PD ISO/TR 13154:2009 which is withdrawn.The UK participation in its preparation was entrusted by TechnicalCommittee CH/121, Anaesthetic and respiratory equipment, toSubcommittee CH/121/9, Lung Ventilators multiple 21During the outbreaks of pandemics, inter

3、nationally agreed measures designed to restrict the movement of possibly infected people were instituted and were assessed by WHO to have greatly contributed to bringing the disease under control.Possible measures to delay or slow the transmission of infectious diseases include: providing travel adv

4、ice on travel to and from affected countries; providing health information for exiting and returning travellers; providing health screening at ports of entry and exit.1112182027282930313237404142434445In a severe pandemic, absenteeism attributable to illness, the need to care for ill family members

5、and fear of infection can reach 40 % during the peak weeks of a community outbreak, with lower rates of absenteeism during the weeks before and after the peak. Certain public health measures (closing schools, quarantining household contacts of infected individuals) are likely to increase rates of ab

6、sence from the workplace. Actions that reduce the likelihood of disease exposure and limit transmission, assure the public of the ability to maintain domestic safety and security, advise the public to curtail non-essential travel and communal activities while preparing for implementation of communit

7、y disease containment measures as the epidemic spreads, are important public policy objectives.91011To support the objective of pandemic prevention, a screening thermograph with appropriate follow-up of febrile persons can be useful to separate potentially infectious individuals from others in locat

8、ions such as:20 entrances to hospitals and clinics, including emergency rooms; entrances to critical infrastructure facilities; entrances to workplaces; entrances to schools; entrances to government buildings, including police and fire stations; entrances to other communal locations; public transpor

9、tation.A screening thermograph should be an element of the layered screening process for those diseases specifically associated with elevated fever. It can also play an important epidemiological role in defining vi ISO 2017 All rights reservedPD ISO/TR 13154:2017ISO/TR 13154:2017(E)the geographical

10、boundaries of an outbreak. A screening thermograph complying with IEC 80601-2-59 is a non-contact, accurate and repeatable means of quickly screening individuals for fever when proper procedures are followed.International experience has demonstrated numerous instances of noncompliance with the Inter

11、national Standard and the recommendations of the first edition of this document, as well as Internet postings documenting inappropriate use of radiometry and infrared cameras. It should emphasized that the efficacy and utility of this technology is contingent on the use of both equipment and protoco

12、ls meeting the recommendations of these committees.45NOTE The requirements for a screening thermograph are found in IEC 806012-59.In this document, the following print types are used: Text and definitions: roman type. Informative material appearing outside of tables, such as notes, examples and refe

13、rences: in smaller type. Normative text of tables is also in a smaller type. Terms defined in clause 3 or as noted: small capitals.In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. ISO 2017 All rights reserved vii

14、PD ISO/TR 13154:2017Medical electrical equipment Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph1 ScopeThis document provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to

15、be used for non-invasive febrile temperature screening of individuals under indoor environmental conditions to prevent the spread of infection.NOTE The equipment standard for screening thermographs is found in IEC 806012-59.2 Normative referencesThere are no normative references in this document.3 T

16、erms and definitionsFor the purposes of this document, the following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online browsing platform: availa

17、ble at h t t p :/ www .iso .org/ obpNOTE For convenience, an alphabetized index of defined terms used in this document is given in Annex C.3.1accessoryadditional part for use with equipment in order to achieve the intended use; adapt it to some special use; facilitate its use; enhance its performanc

18、e; enable its functions to be integrated with those of other equipment.SOURCE: IEC 60601-1:2005, 3.33.2accompanying documentdocument accompanying me equipment, an me system, equipment or an accessory and containing information for the responsible organization or operator, particularly regarding basi

19、c safety and essential performanceSOURCE: IEC 60601-1:2005, 3.4TECHNICAL REPORT ISO/TR 13154:2017(E) ISO 2017 All rights reserved 1PD ISO/TR 13154:2017ISO/TR 13154:2017(E)3.3applied partpart of me equipment that in normal use necessarily comes into physical contact with the patient for me equipment

20、or an me system to perform its functionSOURCE: IEC 60601-1:2005, 3.8, modified - deleted Notes 1, 2 and 33.4basic safetyfreedom from unacceptable risk directly caused by physical hazards when me equipment is used under normal condition and single fault conditionSOURCE: IEC 60601-1:2005, 3.103.5calib

21、rationset of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material and the corresponding values realized by standardsSOURCE: IEC

22、 80601-2-59:, 201.3.2013.6clinical thermometerme equipment used for measuring at the measuring site and indicating the temperature at the reference body siteNote 1 to entry: The measuring site can be the same as the reference body site.SOURCE: ISO 80601-2-56:, 201.3.2073.7emissivityratio of the emit

23、ted thermal rate of propagation of electromagnetic energy emitted by an object as a consequence of its temperature propagated in a given direction, per unit solid angle about that direction and per unit area projected normal to the direction of a surface to that of an ideal blackbody at the same tem

24、perature and under the same spectral conditionsNote 1 to entry: The emissivity of wet or dry human skin is accepted to be 0,98.4748Note 2 to entry: An ideal blackbody is described in Plancks Law.SOURCE: IEC 80601-2-59:, 201.3.2043.8essential performanceperformance of a clinical function, other than

25、that related to basic safety, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable riskNote 1 to entry: Essential performance is most easily understood by considering whether its absence or degradation would result in an unacceptable risk.SOURCE: IEC 6

26、0601-1:2005 + AMD1: 2012, 3.273.9external temperature reference sourcepart of the screening thermograph that is used to ensure accurate operation between calibrations using an infrared radiation source of known temperature and emissivityNote 1 to entry: The external temperature reference source is n

27、ormally imaged in each thermogram of the face or prior to each thermogram of the FACE.SOURCE: IEC 80601-2-59:, 201.3.2052 ISO 2017 All rights reservedPD ISO/TR 13154:2017ISO/TR 13154:2017(E)3.10faceanterior cranial face of the patient being measuredSOURCE: IEC 80601-2-59:, 201.3.2063.11fixedterm mea

28、ning fastened or otherwise secured at a specific location either permanently or so that it can only be detached by means of a toolSOURCE: IEC 60601-1:2005 + AMD1: 2012, 3.30, modified - deleted Note 1 and the examples3.12functional connectionconnection, electrical or otherwise, including those inten

29、ded to transfer signals, data, power or substancesNote 1 to entry: Connection to a fixed supply mains socket-outlet, whether single or multiple, is not considered to result in a functional connection.Note 2 to entry: A network/data coupling is a functional connection.SOURCE: IEC 60601-1:2005, 3.33,

30、modified - added Note 23.13harmphysical injury or damage to the health of people or animals, or damage to property or the environmentSOURCE: IEC 60601-1:2005 + AMD1: 2012, 3.383.14hazardpotential source of harmSOURCE: IEC 60601-1:2005 + AMD1: 2012, 3.393.15intended useuse for which a product, proces

31、s or service is intended according to the specifications, instructions and information provided by the manufacturerNote 1 to entry: Intended use should not be confused with normal use. While both include the concept of use as intended by the manufacturer, intended use focuses on the medical purpose

32、while normal use incorporates not only the medical purpose, but also maintenance, transport, etc.SOURCE: IEC 60601-1:2005 + AMD1: 2012, 3.443.16manufacturernatural or legal person with responsibility for the design, manufacture, packaging, or labelling of me equipment, assembling an me system, or ad

33、apting me equipment or an me system, regardless of whether these operations are performed by that person or on that persons behalf by a third partyNote 1 to entry: ISO 1348549defines “labelling” as written, printed or graphic matter: affixed to a medical device or any of its containers or wrappers,

34、or accompanying a medical device,related to identification, technical description, and use of the medical device, but excluding shipping documents. In this document, that material is described as markings and accompanying documents. ISO 2017 All rights reserved 3PD ISO/TR 13154:2017ISO/TR 13154:2017

35、(E)Note 2 to entry: “Adapting” includes making substantial modifications to me equipment or an me system already in use.Note 3 to entry: In some jurisdictions, the responsible organization can be considered a manufacturer when involved in the activities described.Note 4 to entry: Adapted from ISO 14

36、971:2007, 2.850.SOURCE: IEC 60601-1:2005 + AMD1: 2012, 3.55, modified - replaced “standard” with “document” in Note 13.17measuring sitepart of a patient where the temperature is measuredEXAMPLE Pulmonary artery, distal oesophagus, sublingual space in the mouth, rectum, ear canal, axilla (armpit), fo

37、rehead skin.Note 1 to entry: This definition refers to sites measured by the thermometry.SOURCE: ISO 80601-2-56:, 201.3.213, modified - added Note 13.18medical electrical equipmentme equipmentelectrical equipment having an applied part or transferring energy to or from the patient or detecting such

38、energy transfer to or from the patient and which is:a) provided with not more than one connection to a particular supply mains; andb) intended by its manufacturer to be used:1) in the diagnosis, treatment or monitoring of a patient or2) for compensation or alleviation of disease, injury or disabilit

39、yNote 1 to entry: Me equipment includes those accessories, as defined by the manufacturer, which are necessary to enable the normal use of the me equipment.Note 2 to entry: Not all electrical equipment used in medical practice falls within this definition (e.g. some in vitro diagnostic equipment).No

40、te 3 to entry: The implantable parts of active implantable medical devices can fall within this definition, but they are excluded from the scope of this document by appropriate wording in Clause 1.SOURCE: IEC 60601-1:2005 + AMD1: 2012, 3.63, modified - replaced “standard” by “document” in Note 3 and

41、 deleted Notes 4 and 53.19medical electrical systemme systemcombination, as specified by its manufacturer, of items of equipment, at least one of which is me equipment to be inter-connected by a functional connection or by use of a multiple socket-outletNote 1 to entry: Equipment, when mentioned in

42、this document, includes me equipment.SOURCE: IEC 60601-1:2005 + AMD1: 2012, 3.64, modified - replaced “standard” by “document” in Note 14 ISO 2017 All rights reservedPD ISO/TR 13154:2017ISO/TR 13154:2017(E)3.20multiple socket-outletone or more socket-outlets intended to be connected to, or integral

43、with, flexible cables, cords or me equipment providing supply mains or equivalent voltageNote 1 to entry: A multiple socket-outlet can be a separate item or an integral part of the equipment.SOURCE: IEC 60601-1:2005 + AMD1: 2012, 3.673.21network/data couplingany means to transmit or receive informat

44、ion to or from other equipment in accordance with the manufacturers specificationsNote 1 to entry: A network/data coupling is a functional connection.SOURCE: IEC 60601-1:2005, 3.68, modified - added Note 13.22normal conditioncondition in which all means provided for protection against hazards are in

45、tactSOURCE: IEC 60601-1:2005, 3.703.23normal useoperation, including routine inspection and adjustments by any operator, and stand-by, according to the instructions for useNote 1 to entry: normal use should not be confused with intended use. While both include the concept of use as intended by the m

46、anufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purpose, but maintenance, transport, etc.SOURCE: IEC 60601-1:2005 + AMD1: 2012, 3.713.24operatorperson handling equipmentSOURCE: IEC 60601-1:2005 + AMD1: 2012, 3.73, modified - deleted note3.2

47、5output temperaturetemperature indicated by a thermometerNote 1 to entry: Methods of indication can include printed, spoken, displayed and displayed remotely.SOURCE: ISO 80601-2-56:, 201.3.2163.26patientliving being (person or animal) undergoing a medical, surgical or dental procedureSOURCE: IEC 606

48、01-1:2005 + AMD1: 2012, 3.76, modifed - deleted note3.27recorddocument stating results achieved or providing evidence of activities performedSOURCE: IEC 60601-1:2005 + AMD1: 2012, 3.98 ISO 2017 All rights reserved 5PD ISO/TR 13154:2017ISO/TR 13154:2017(E)3.28reference body sitepart of a patient to w

49、hich the output temperature refersEXAMPLE Pulmonary artery, distal oesophagus, sublingual space in the mouth, rectum, ear canal, axilla (armpit), forehead skinSOURCE: ISO 80601-2-56:, 201.3.2203.29responsible organizationentity accountable for the use and maintenance of an me equipment or an me systemNote 1 to entry: The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In home