ISO/TR 13154:2017
(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 13154:2017 provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to 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 80601?2-59.
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
Second edition
2017-03
Medical electrical equipment —
Deployment, implementation and
operational guidelines for identifying
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 2017
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved
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 .19
Alphabetical index .22
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by 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.
This second edition cancels and replaces the first edition (ISO/TR 13154:2009), which has been
technically revised.
iv © ISO 2017 – All rights reserved
Introduction
[1]
The purpose of this document is to provide guidance on the implementation of IEC 80601-2-59 to
minimize the spread of infectious diseases. The first edition of this document was derived, in part,
[2]
from SPRING Technical Reference 15. The SPRING Technical Reference was created as result of
[3][4][5][6][7]
the Singapore experiences during the SARS epidemic. The scale of the global problem has
increased in recent years, with emergence of infectious disease with pandemic potential as a threat
to public health. Pandemics of infectious diseases (e.g. influenza) have swept the world from time to
time throughout history and have caused widespread illness, large numbers of deaths, notably among
children and young adults, and huge societal disruption. New pandemic sources emerge with serious
[5][8]
consequences, with potential to affect a quarter of the world population over one or more cycles.
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
[9][10][11][12]
communication are key to preparing for and responding to a pandemic.
The ability to limit the spread of a pandemic disease, direct public health interventions, and limit the
unintended consequences of these actions is greatly enhanced by the widespread availability of cost-
[13][14]
effective screening methods for infectious diseases 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, isolation/quarantine of suspected cases
or treatment with appropriate medication, can help delay or limit the spread of a disease once a case
has been identified. 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 the spread, including local, regional and national
entry and exit restrictions based on veterinary and health monitoring, screening and surveillance for
[15][16][17]
humans, animals, and animal products , and information sharing and cooperation to manage
[9][10]
borders.
[9][11][18][19][20] [5]
Pandemic disease includes, but is not limited to, such infections as influenza , SARS
[6][7] [21] [22][23][24][25][26]
, tuberculosis , Middle East Respiratory Syndrome (MERS) , haemorrhagic
[13][27][28][29][30] [31][32][33]
fevers (e.g. Ebola) and other biological or bacterial agents. Table 1 contains
examples of infectious diseases characterized by fever for which thermographic fever screening can
be useful. On the other hand, pandemic diseases such as Zika virus are not necessarily accompanied
[34][35]
by high fever and are therefore not suitable for thermographic fever screening. The sources of
such diseases can be naturally occurring, accidental releases or the result of subversive activities or
terrorism.
Individual screening of all persons entering a country, for infectious illness and exposure factors for
[27][36]
infection with a pandemic strain, helps minimize the likelihood of transmission. However, such
screening is challenged by a lack of sensitivity (e.g. asymptomatic infected individuals might not be
detected) and specificity (e.g. many individuals exhibiting symptoms might not be infected with a
pandemic strain). For example, the typical incubation period for influenza is two days, and infected
persons with influenza can be contagious for 24 h prior to the onset of symptoms. Other possible
[37][38]
pandemic diseases have varying periods of latency or incubation. Since some asymptomatic
travellers who are incubating a disease can 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, can 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.
[9][13][14][38]
Table 1 — Examples of infectious diseases characterized by fever, identifiable
by thermographic fever screening
Infectious disease Pathogen Transmission mode References
Ebola virus disease Ebola virus Blood, body fluids [12][28][29][30][37][39][40]
(EVD)
Influenza Influenza viruses Airborne or contact [9][10][11][14][16][18][19][41][42]
with infected humans,
birds or animals, or
their remains
Middle East MERS coronavirus Contact with virally [22][23][24][25][26]
Respiratory (CoV) contaminated surfaces
Syndrome-
coronavirus (MERS)
Severe acute SARS virus Airborne [5][6][7]
respiratory syndrome (coronavirus)
(SARS)
Tuberculosis Myobacterium Airborne; multiple [21]
tuberculosis
During the outbreaks of pandemics, internationally 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 advice on travel to and from affected countries;
— providing health information for exiting and returning travellers;
[11][12][18][20][27][28][29][30][31][32][37][40][41][42]
— providing health screening at ports of entry and exit.
[43][44][45]
In a severe pandemic, absenteeism attributable to illness, the need to care for ill family members 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 absence
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 implementa
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