ISO/TR 13154:2009
(Main)Medical electrical equipment — Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
Medical electrical equipment — Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph
ISO/TR 13154:2009 provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to be used for individual non-invasive febrile temperature screening of humans under indoor environmental conditions to prevent the spread of infection.
Équipement électrique médical — Déploiement, mise en oeuvre et lignes directrices opérationnelles pour l'identification d'êtres humains fébriles en utilisant un thermographe de criblage
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TECHNICAL ISO/TR
REPORT 13154
First edition
2009-04-01
Medical electrical equipment —
Deployment, implementation and
operational guidelines for identifying
febrile humans using a screening
thermograph
Équipement électrique médicale — Déploiement, mise en oeuvre et
lignes directrices opérationnelles pour l'identification d'êtres humains
fébriles en utilisant un thermographe de criblage
Reference number
ISO/TR 13154:2009(E)
©
ISO 2009
---------------------- Page: 1 ----------------------
ISO/TR 13154:2009(E)
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TECHNICAL ISO/TR
REPORT 13154
First edition
2009-04-01
Medical electrical equipment —
Deployment, implementation and
operational guidelines for indentifying
febrile humans using a screening
thermograph
Équipement électrique médical — Déploiement, mise en oeuvre et
lignes directrices opérationnelles pour l'identification d'êtres humains
fébriles en utilisant un thermographe de criblage
Reference number
ISO/TR 13154:2009(E)
©
ISO 2009
---------------------- Page: 1 ----------------------
ISO/TR 13154:2009(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2009
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ii © ISO 2009 – All rights reserved
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ISO/TR 13154:2009(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 General considerations. 7
5 Planning for deployment. 8
5.1 General. 8
5.2 Condition of screening site . 8
5.3 Design of screening operation . 9
5.4 Selection of screening thermograph . 9
6 Operation . 9
6.1 System setup. 9
6.2 Screening protocol . 10
6.3 Interpretation of screening results . 10
6.4 Requirements of the operator . 11
6.5 Requirements of the responsible organization . 11
7 Data storage and security. 12
Annex A (informative) Deployment considerations. 13
Annex B (informative) Example facial thermograms . 15
Bibliography . 18
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ISO/TR 13154:2009(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TR 13154 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee IEC/TC 62, Electrical
equipment in medical practice, Subcommittee SC D, Electromedical equipment.
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ISO/TR 13154:2009(E)
Introduction
[1] [2]
This Technical Report was derived, in part, from SPRING Technical Reference 15. The SPRING Technical
[6] [7] [10] [12] [13] [16]
Reference was created as result of the Singapore experiences during the SARS epidemic.
Pandemics of influenza have swept the world from time to time throughout history, including three times in the
last century. They caused widespread illness, large numbers of deaths, notably among children and young
adults, and huge societal disruption, concentrated in just a few weeks. There is currently rising concern that a
new influenza virus with pandemic potential will emerge and spread, and a further pandemic can be expected.
It is not known when that will be but the consequences, whenever it occurs, will be serious, with around a
quarter of the population possibly affected. This could be over one or more cycles, each lasting around
three months. See Reference [10]. It should be noted that current estimates indicate that it will take
approximately five months to develop, produce and distribute a pandemic vaccine following the declaration of
a pandemic and isolation of the pandemic virus. See Reference [12].
The prime objectives of pandemic planning are to save lives, reduce the health impact of a pandemic and
minimize disruption to health and other essential services, while maintaining business continuity as far as is
possible and reducing the general disruption to society that is likely to ensue, serious though this will be.
Strong leadership, organization and co-ordination, and clear lines of accountability and communication will be
key to preparing for, and responding to, a pandemic.
The ability to limit the spread of a pandemic disease, target public health interventions, and limit the
unintended consequences of these actions will be greatly enhanced by the widespread availability of cost-
effective screening tools for influenza viruses such as rapid diagnostic tests. Early outbreak detection with
continued surveillance of travellers and the institution of appropriate measures, including social distancing,
isolation of infected individuals, quarantine of suspected cases or treatment with antiviral medication, can help
delay or limit the spread of a virus once a case occurs. Well-coordinated international implementation of entry
and exit restrictions is an important component of an effective global response to contain cases and prevent a
pandemic. All countries should prepare to implement steps to limit spread, including local, regional and
national entry and exit restrictions based on veterinary and health monitoring, screening and surveillance for
humans, animals, and animal products, and information-sharing and cooperation to manage borders. See
Reference [5].
Influenza is not the only possible pandemic disease. SARS, tuberculosis, anthrax, MRSA and other biological
or bacterial agents can cause a widespread pandemic. The sources of such diseases can be naturally
occurring, accidental releases or the result of subversive activities.
Individual screening of all persons entering a country, for influenza-like illness and risk factors for infection
with a pandemic strain, will help minimize the likelihood of transmission. However, such screening is
challenged by a lack of sensitivity (e.g. asymptomatic infected individuals may not be detected) and specificity
(e.g. many individuals with influenza-like illness will not be infected with a pandemic strain). The typical
incubation period for influenza is two days, and infected persons with influenza may be contagious for 24 h
prior to the onset of symptoms. Other possible pandemic diseases have longer incubation periods. Since
some asymptomatic travellers who are incubating a disease may become symptomatic en route, overall
screening effectiveness can be improved by adopting layered pre-departure, en route and arrival screening
measures. The policy of layered screening measures should apply to all in-bound travellers from affected
areas, but the characteristics of the outbreak, including the rapidity of spread, may make it necessary to
implement this screening at all international airports from which passengers originate. In addition, development
of rapid diagnostic tests can dramatically change our ability to screen effectively. See Reference [5].
During the outbreaks of severe acute respiratory syndrome (SARS) in 2003, internationally agreed measures
designed to restrict the movement of people possibly infected with SARS were instituted and were assessed
by WHO to have greatly contributed to bringing the disease under control.
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ISO/TR 13154:2009(E)
Influenza is more infectious than SARS, is most infectious early in the course of the disease (and possibly
even before symptoms begin), and has a much shorter incubation period (one to three days). These important
differences make it unlikely that similar interventions will do more than delay or slow the transmission of
pandemic influenza at best, but this may still be deemed useful. Possible measures include:
⎯ providing travel advice on travel to and from affected countries;
⎯ providing health information for exiting and returning travellers;
⎯ providing health screening at ports of entry and exit; see Reference [15].
In a severe pandemic, absenteeism attributable to illness, the need to care for ill family members and fear of
infection may 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 absenteeism. 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 community disease containment measures as epidemic spreads, are important public
policy objectives. See Reference [5]. To support these objectives, a screening thermograph can be useful to
separate potentially infectious individuals from others in pandemic situations in locations such as:
⎯ 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;
⎯ public transportation.
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 the
geographical boundaries of an outbreak. A screening thermograph is a non-contact, accurate and repeatable
means of quickly screening individuals for fever when proper procedures are followed.
NOTE The requirements for a screening thermograph are found in IEC 80601-2-59.
vi © ISO 2009 – All rights reserved
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TECHNICAL REPORT ISO/TR 13154:2009(E)
Medical electrical equipment — Deployment, implementation
and operational guidelines for indentifying febrile humans
using a screening thermograph
IMPORTANT — The colours represented in the electronic file of this document are considered as
important colours for a correct understanding and use of this document but are not considered as
mandatory precise colours. ISO strongly recommends to print this electronic file on a colour printer.
1 Scope
This Technical Report provides general guidelines for the deployment, implementation and operation of a
screening thermograph intended to be used for individual non-invasive febrile temperature screening of
humans under indoor environmental conditions to prevent the spread of infection.
NOTE The equipment standard for screening thermographs is found in IEC 80601-2-59.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 80601-2-56, Medical electrical equipment — Part 2-56: Particular requirements for basic safety and
essential performance of clinical thermometers for body temperature measurement
IEC 80601-2-59, Medical electrical equipment — Part 2-59: Particular requirements for the basic safety and
essential performance of screening thermographs for human febrile temperature screening
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accessory
additional part for use with equipment in order to:
⎯ achieve the intended use;
⎯ adapt it to some special use;
⎯ facilitate its use;
⎯ enhance its performance;
⎯ enable its functions to be integrated with those of other equipment
[IEC 60601-1:2005, definition 3.3]
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ISO/TR 13154:2009(E)
3.2
accompanying document
document accompanying me equipment, an me system, equipment or an accessory and containing
information for the responsible organization or operator, particularly regarding basic safety and essential
performance
[IEC 60601-1:2005, definition 3.4]
3.3
applied part
part of me equipment that in normal use necessarily comes into physical contact with the patient for
me equipment or an me system to perform its function
3.4
basic safety
freedom from unacceptable risk directly caused by physical hazards when me equipment is used under
normal condition and single fault condition
[IEC 60601-1:2005, definition 3.10]
3.5
calibration
set 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 standards
[IEC 80601-2-59:2008, definition 201.3.201]
3.6
clinical thermometer
me equipment used for measuring at the measuring site and indicating the temperature at the reference
body site
NOTE The measuring site can be the same as the reference body site.
1)
[ISO 80601-2-56:— , definition 201.3.206]
3.7
emissivity
ratio of the emitted 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
temperature and under the same spectral conditions
NOTE 1 The emissivity of dry human skin is accepted to be 0,98.
NOTE 2 An ideal blackbody is described by Planck's Law.
[IEC 80601-2-59:2008, definition 201.3.204]
3.8
essential performance
performance necessary to achieve freedom from unacceptable risk
NOTE Essential performance is most easily understood by considering whether its absence or degradation would
result in an unacceptable risk.
[IEC 60601-1:2005, definition 3.27]
1) To be published.
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ISO/TR 13154:2009(E)
3.9
external temperature reference source
part of the screening thermograph that is used to ensure accurate operation between calibrations using an
infrared radiation source of known temperature and emissivity
NOTE The external temperature reference source is normally imaged in each thermogram or prior to each
thermogram.
[IEC 80601-2-59:2008, definition 201.3.205]
3.10
face
anterior cranial face of the patient being measured
[IEC 80601-2-59:2008, definition 201.3.206]
3.11
functional connection
connection, electrical or otherwise, including those intended to transfer signals, data, power or substances
NOTE 1 Connection to a fixed supply mains socket-outlet, whether single or multiple, is not considered to result in a
functional connection.
[IEC 60601-1:2005, definition 3.33]
NOTE 2 A network/data coupling is a functional connection.
3.12
harm
physical injury or damage to the health of people or animals, or damage to property or the environment
[IEC 60601-1:2005, definition 3.38]
3.13
hazard
potential source of harm
[IEC 60601-1:2005, definition 3.39]
3.14
intended use
use of a product, process or service in accordance with the specifications, instructions and information
provided by the manufacturer
NOTE 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 while normal use incorporates not only the medical
purpose, but also maintenance, service, transport, etc.
[IEC 60601-1:2005, definition 3.44]
3.15
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging, or labelling of
me equipment, assembling an me system, or adapting me equipment or an me system, regardless of
whether these operations are performed by that person or on that person's behalf by a third party
[17]
NOTE 1 ISO 13485 defines “labelling” as written, printed or graphic matter:
— affixed to a medical device or any of its containers or wrappers or
— accompanying a medical device,
related to identification, technical description, and use of the medical device, but excluding shipping documents. In this
Technical Report, that material is described as markings and accompanying documents.
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ISO/TR 13154:2009(E)
NOTE 2 “Adapting” includes making substantial modifications to me equipment or an me system already in use.
NOTE 3 In some jurisdictions, the responsible organization can be considered a manufacturer when involved in the
activities described.
NOTE 4 Adapted from ISO 14971:2007, definition 2.8.
[IEC 60601-1:2005, definition 3.55]
3.16
measuring site
part of a patient where the temperature is measured
EXAMPLES Pulmonary artery, distal esophagus, sublingual cavity in the mouth, rectum, ear canal, axilla (armpit),
forehead skin.
[ISO 80601-2-56:—, definition 201.3.212]
3.17
medical electrical equipment
me equipment
electrical equipment having an applied part or transferring energy to or from the patient or detecting such
energy transfer to or from the patient and which is:
a) provided with not more than one connection to a particular supply mains;
b) intended by its manufacturer to be used:
1) in the diagnosis, treatment or monitoring of a patient or
2) for compensation or alleviation of disease, injury or disability
NOTE 1 Me equipment includes those accessories, as defined by the manufacturer, which are necessary to enable
the normal use of the me equipment.
NOTE 2 Not all electrical equipment used in medical practice falls within this definition (e.g. some in vitro diagnostic
equipment).
NOTE 3 The implantable parts of active implantable medical devices can fall within this definition, but they are
excluded from the scope of this Technical Report by appropriate wording in Clause 1.
[IEC 60601-1:2005, definition 3.63]
3.18
medical electrical system
me system
combination, 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-outlet
NOTE Equipment, when mentioned in this Technical Report, includes me equipment.
[IEC 60601-1:2005, definition 3.64]
3.19
multiple socket-outlet
one or more socket-outlets intended to be connected to, or integral with, flexible cables or cords or
me equipment for supply mains or equivalent voltage
NOTE A multiple socket-outlet can be a separate item or an integral part of the equipment.
[IEC 60601-1:2005, definition 3.67]
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ISO/TR 13154:2009(E)
3.20
network/data coupling
any means to transmit or receive information to or from other equipment in accordance with the
manufacturer's specifications
NOTE A network/data coupling is a functional connection.
[IEC 60601-1:2005, definition 3.68]
3.21
normal condition
condition in which all means provided for protection against hazards are intact
[IEC 60601-1:2005, definition 3.70]
3.22
normal use
operation, including routine inspection and adjustments by any operator, and stand-by, according to the
instructions for use
NOTE Normal use should not be confused with intended use. While both include the concept of use as intended by
the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical
purpose, but also maintenance, service, transport, etc.
[IEC 60601-1:2005, definition 3.71]
3.23
objective evidence
information that can be proven true, based on facts obtained through observation, measurement, test or other
means
[IEC 60601-1:2005, definition 3.72]
3.24
operator
person handling equipment
[IEC 60601-1:2005, definition 3.73]
3.25
output temperature
temperature indicated by a thermometer
NOTE Methods of indication can include: printed, spoken, displayed and displayed remotely.
[ISO 80601-2-56:—, definition 201.3.215]
3.26
patient
living being (person or animal) undergoing a medical, surgical or dental procedure
NOTE In the context of this Technical Report, an individual being screened is a patient.
[IEC 60601-1:2005, definition 3.76]
3.27
record
document that furnishes objective evidence of activities performed or results achieved
[IEC 60601-1:2005, definition 3.98]
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ISO/TR 13154:2009(E)
3.28
reference body site
part of a patient to which the output temperature refers
[ISO 80601-2-56:—, definition 201.3.219]
3.29
responsible organization
entity accountable for the use and maintenance of an me equipment or an me system
NOTE 1 The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In home use
applications; the patient, operator and responsible organization can be one and the same person.
NOTE 2 Education and training is included in “use”.
[IEC 60601-1:2005, definition 3.101]
3.30
risk
combination of the probability of occurrence of harm and the severity of that harm
[IEC 60601-1:2005, definition 3.102]
3.31
screening thermograph
me equipment or me system that:
⎯ detects infrared radiation emitted from the face, from which a thermogram is obtained from the target;
⎯ detects infrared radiation emitted from an external temperature reference source;
⎯ displays a radiometric thermal image;
⎯ obtains a temperature reading from the target;
⎯ compares that temperature reading to the threshold temperature to determine if the patient is febrile
NOTE 1 A screening thermograph is non-contact, non-invasive temperature screening me equipment used to
measure the face temperature and indicate the screened region with a different colour if the temperature is above the
threshold temperature setting.
NOTE 2 A screening thermograph has to identify the target from the thermogram to obtain the target temperature
reading.
[IEC 80601-2-59:2008, definition 201.3.209]
3.32
severity
measure of the possible consequences of a hazard
[IEC 60601-1:2005, definition 3.114]
3.33
single fault condition
condition in which a single means for reducing a risk is defective or a single abnormal condition is present
[IEC 60601-1:2005, definition 3.116]
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ISO/TR 13154:2009(E)
3.34
skin temperature
skin surface temperature as measured from the workable target plane of a screening thermograph, with an
appropriate adjustment for skin emissivity
NOTE The emissivity of dry human skin is accepted to be 0,98.
[IEC 80601-2-59:2008, definition 201.3.211]
3.35
supply mains
source of electrical energy not forming part of me equipment or me system
NOTE This also includes battery systems and converter systems in ambulances and the like.
[IEC 60601-1:2005, definition 3.120]
3.36
target
region of the face selected for threshold temperature comparison
[IEC 80601-2-59:2008, definition 201.3.212]
3.37
target plane
in-focus plane perpendicular to the line of sight of a screening thermograph
[IEC 80601-2-59:2008, definition 201.3.213]
3.38
training
application-specific operator-oriented instruction or exercises required for the safe and effective use of the
me equipment
[IEC 60601-1-6:2006, definition 3.8]
3.39
threshold temperature
temperature setting above which the screening thermograph indicates that the target is potentially febrile
NOTE This is typically indicated in degrees centigrade.
[IEC 80601-2-59:2008, definition 201.3.214]
3.40
workable target plane
region of the target plane which meets the specified performance requirements
NOTE The workable target plane can be the whole or a part of the target plane.
[IEC 80601-2-59:2008, definition 201.3.215]
4 General considerations
This Technical Report is concerned with the aspects of the practical use of screening thermographs used to
detect a febrile condition in various cohorts of humans, the intended use of a screening thermograph.
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ISO/TR 13154:2009(E)
Deployment provides guidelines on the appropriate physical positioning and use of screening thermographs
in:
⎯ international and national points-of-entry and points-of-exit;
⎯ hospital and clinic entrances;
⎯ points-of-entry to buildings designated by an authority with jurisdiction;
⎯ points-of-entry to buildings used by the general public;
⎯ points-of-entry to and points-of-exit from workplaces.
Implementation requirements should consider the information that can be obtained by such screening and its
further value in maintaining appropriate public health standards.
The operational demands of a sc
...
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