ISO/TR 21730:2005

TECHNICAL ISO/TR
REPORT 21730
First edition
2005-01-15

Health informatics — Use of mobile
wireless communication and computing
technology in healthcare facilities —
Recommendations for the management
of unintentional electromagnetic
interference with medical devices
Informatique de santé — Utilisation de communications mobiles sans fil
et des technologies informatisées dans les structures de soins —
Recommandations pour la gestion des interférences
électromagnétiques non intentionnelles avec les dispositifs médicaux




Reference number
ISO/TR 21730:2005(E)
©
ISO 2005

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ISO/TR 21730:2005(E)
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ISO/TR 21730:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Terms, definitions and abbreviated terms. 1
2.1 Terms and definitions. 1
2.2 Abbreviated terms. 2
3 Requirements . 3
3.1 Mobile wireless equipment in healthcare facilities . 3
3.2 The risk of patient harm due to EMI. 5
3.3 Existing relevant standards and recommendations . 6
3.4 Minimization of EMI risk . 8
4 Recommendations . 8
4.1 General Recommendations. 8
4.2 Responsibility within healthcare facilities. 9
4.3 Inventory within healthcare facilities . 9
4.4 Testing within healthcare facilities . 9
4.5 Controlled use within healthcare facilities. 10
4.6 Non-Controlled use within healthcare facilities. 11
4.7 Medical devices within healthcare facilities. 12
Annex A (informative) RF technologies . 13
Bibliography . 19

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ISO/TR 21730:2005(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 21730 was prepared by Technical Committee ISO/TC 215, Health Informatics, Task Force on EMC in
RF mobile communications.
Other international organizations that contributed to the preparation of this Technical Report, mainly in review
and comment of draft text, include, from the UK the MHRA and the IST/35 Mirror Panel, from the US the FDA,
from Australia the Australian Therapeutic Goods Administration, Telstra, and Monash Medical Center, from
Canada Health Canada Medical Devices Bureau, from the Netherlands the Health Council of the Netherlands,
from Finland the National Agency for Medicines, and from Switzerland Swissmedic.
Due to rapidly changing technologies, this report must be regarded as a “living document” and comments for
improvement will therefore be welcomed.
The current Technical Report strongly parallels the AAMI TIR #18, which provides similar recommendations
for wireless equipment in healthcare facilities.

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ISO/TR 21730:2005(E)
Introduction
There is a growing need in healthcare facilities throughout the world to incorporate new technology to offer
more efficient, cost-effective and higher quality healthcare. In that regard, wireless communication and
computing technologies have the potential to offer significant advancements to healthcare communication and
health informatics exchange. Such wireless technologies include the use of mobile phones, handheld
computers/PDAs, WiFi/802.11.a/b/g local area networks and wireless modems for laptop computers, personal
area networks including 802.15.1 (Bluetooth)/802.15.4 (Zigbee)/802.15.3a (UWB), two-way pagers, radios, etc.
In addition, visitors and patients are also finding use of personal mobile phones and other wireless devices
within healthcare facilities increasingly indispensable, especially in times of crisis.
Currently, no uniform international guideline exists for the appropriate deployment, use, and management of
mobile wireless communication and computing technology within healthcare facilities to mitigate potential
electromagnetic interference (EMI) with sensitive medical devices. Although medical device manufacturers
generally comply with recommended immunity guidelines (10 V/m for life-critical devices as outlined in the
recently approved second edition of the IEC International Standard 60601-1-2), there is no consistent
international regulation enforcing this recommendation. In addition, many mobile wireless transmitters exceed
this field strength threshold when operating at their upper power limits and in close proximity. Finally, there are
a number of older medical devices still in circulation that have not been designed with the above immunity
considerations in mind.
Misinformation regarding mobile wireless systems, electromagnetic interference, and management
procedures has led to a range of inconsistent policies among healthcare organizations. At one extreme,
overly-restrictive policies may act as obstacles to beneficial technology as well as not address the growing
personal communication needs of patients, visitors, and the workforce. At the other extreme, unmanaged use
can place patients at risk. An equally important factor in this issue is that healthcare organizations throughout
the world have a variety of different resources, needs, concerns, and RF environments that may not all be
addressed by implementation of a single prescriptive management strategy. Because of this, a balanced
approach is necessary to ensure that all the benefits of mobile wireless technology can be made available to
healthcare organizations that desire to fully implement comprehensive management procedures, while
sufficient safeguards are offered to organizations where these same comprehensive management procedures
cannot be, or otherwise have not been, fully implemented.
It may not be feasible for healthcare organizations to manage every mobile wireless handset brought into their
facility without certain restrictive limits. The necessary range and extent of restrictive limits within a given
healthcare facility will depend upon the level of management that has been implemented. For mobile wireless
equipment that is randomly brought into the healthcare facility in an uncontrolled manner, policies restricting
use in sensitive areas where life-critical medical devices are in routine operation may be appropriate. Such
restrictive policies might be facilitated by offering numerous and easily accessible alternative areas where the
use of mobile wireless equipment is encouraged. For mobile wireless equipment that is provided to doctors
and staff under more controlled conditions, operation throughout the healthcare facility (even in sensitive
areas) may be achievable with appropriate management. With such management, as outlined in the
recommendations below, it is possible to realize many of the benefits of wireless technology for
healthcare-specific communication and health information access while at the same time sufficiently mitigating
EMI concerns.
Because most mobile wireless communication and computing systems can be effectively managed to mitigate
EMI issues, the choice of technology for a controlled system should be based upon which solution best
addresses the needs of the organization, not on what RF signal types may be inherently more or less prone to
EMI under unmanaged conditions.

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TECHNICAL REPORT ISO/TR 21730:2005(E)

Health informatics — Use of mobile wireless communication
and computing technology in healthcare facilities —
Recommendations for the management of unintentional
electromagnetic interference with medical devices
1 Scope
This International Standard provides guidance for the deployment, use and management of mobile wireless
communication and computing equipment in the healthcare facility in a way that helps mitigate potential
hazards due to electromagnetic interference (EMI) with medical devices. The recommendations recognize the
different resources, needs, concerns and environments of healthcare organizations around the world and
provide detailed management guidelines for healthcare organizations that desire full deployment of mobile
wireless communication and computing technology throughout their facility, as well as selective restrictions for
healthcare organizations that have decided comprehensive management procedures are not feasible,
practical, or desirable at the present time. The recommendations also distinguish between controlled systems
used by doctors and staff for healthcare-specific communication and health informatics transport vs.
non-controlled (personal) mobile wireless equipment randomly brought into the facility by visitors, patients,
and the healthcare organization workforce.
2 Terms, definitions and abbreviated terms
2.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1.1
hertz
Hz
unit of frequency of electromagnetic energy based upon the emitted wavelength
2.1.2
decibel
dB
a relative ratio, one tenth of the common logarithm of the ratio of relative powers, equal to 0,1 B (bel)
NOTE The ratio in dB is given by dB = 10log (P /P ).
10 1 2
2.1.3
decibel
dBm
decibels as above, but relative to a fixed 1 milliwatt of power
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ISO/TR 21730:2005(E)
2.2 Abbreviated terms
AAMI Association for the Advancement of Medical Instrumentation
AHA American Hospital Association
AMA American Medical Association
AMPS Advanced Mobile Phone System
ANSI American National Standards Institute
ASHE American Society for Healthcare Engineering
CDMA Code Division Multiple Access
CDRH Center for Devices and Radiological Health, Department within FDA (United States)
CISPR International Special Committee on Radio Interference
COMAR IEEE Committee on Man and Radiation
DECT Digitally Enhanced Cordless Telecommunications
ECG Electrocardiogram
EEG Electroencephalogram
EMC Electromagnetic Compatibility
EMI Electromagnetic Interference
ESD Electrostatic Discharge
FDA Food and Drug Administration (United States)
FOMA Freedom of Mobile Multimedia Access
GPRS General Packet Radio Service
GSM Global System for Mobile
iDEN Integrated Dispatch Enhanced Network
IEC International Electrotechnical Commission
IEEE Institute for Electrical and Electronics Engineers
ISM Industry, Science and Medicine
ITU International Telecommunication Union
IVDs In Vitro Diagnostic Devices
JCAHO Joint Commission on Accreditation of Healthcare Organizations
JTACS Japanese Total Access Communications System
LAN Local Area Network, including 802.11b and 802.11a systems
LMR Land Mobile Radio
MHRA Medicines and Healthcare Products Regulatory Agency (United Kingdom)
NADC North American Digital Cellular
PAN Personal Area Network, including 802.15.1 (Bluetooth), 802.15.4 (Zigbee), 802.15.3a, etc.
PDA Personal Digital Assistant
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ISO/TR 21730:2005(E)
PDC Personal Digital Cellular
PCS Personal Communications Services
R&TTE Radio and Telecommunications Terminal Equipment
RF Radiofrequency, classically defined as ranging from a few KHz – 300 GHz
Rx Reception, received RF signal
TACS Total Access Communications System
TDMA Time Division Multiple Access
TIR Technical informational Report
Tx Transmission, transmitted RF signal
UMTS Universal Mobile Telecommunications Systems
V/m Volts per metre, a measure of RF electrical field strength
VoIP Voice-over Internet Protocol
WAN Wide Area Network
WAP Wireless Application Protocol
WCDMA Wide band Code Division Multiple Access
WiFi Wireless Fidelity network system
3 Requirements
3.1 Mobile wireless equipment in healthcare facilities
The use of mobile wireless equipment by doctors and healthcare staff for improved healthcare communication
and computing is becoming increasingly common. Visitors and patients are likewise finding the use of
personal mobile phones and wireless devices within healthcare facilities increasingly indispensable, especially
in times of crisis. Such wireless devices might include mobile phones, handheld computers / PDAs,
WiFi / 802.11.a/b/g [1] local area networks and wireless modems for laptop computers, personal area
networks including 802.15.1 (Bluetooth) [2] / 802.15.4 (Zigbee) [3] / 802.15.3a (UWB), two-way pagers, radios,
etc.
Table 1 lists many of the common wireless technologies in use in various healthcare facilities. As can be seen
from Table 1, mobile wireless equipment can transmit on exclusive licensed frequencies, as is the case with
most mobile phones, pagers, and two-way radios, or can operate with many other transmitters on one of the
unlicensed Industry, Science, and Medicine (ISM) bands at 900 MHz and 2,4, 5,2, and 5,8 GHz as is the case
with cordless phones and wireless data network equipment. From a radiofrequency (RF) signal perspective,
mobile wireless transmitters can employ either simple analogue or more complex (and sometimes pulse
modulated) digital technology. In terms of output power, mobile wireless equipment can be segmented into
three broad categories. The first category includes 802.11, 802.15, and most cordless phone-type systems
that transmit constantly at relatively lower power (u 10 milliwatts). A second category consists of two-way
radio and pager systems that transmit at a constant power that is higher by an order of magnitude of more
than 1 to 5 watts. The third category includes dynamically power-controlled equipment that can transmit at
levels from a few milliwatts to 1 to 2 watts based upon the existing network signal strength at that particular
location and time.
An immediate benefit to healthcare that improved mobile wireless communication and computing may provide
is underscored by a U.S. Institute of Medicine (IOM) report estimating that common medical errors, many of
which may be avoided with better communication and computing links, contribute to between 44 000 and
98 000 deaths per year in the United States [4]. A similar percentage was also suggested for the
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ISO/TR 21730:2005(E)
United Kingdom and Australia. Other potential healthcare benefits that wireless technology might provide
include immediate communication and access to patient information, test results, records and medical
reference at the point-of-care, as well as reduction in cost charging errors, reduction in cost and maintenance
of land-line phone systems, and ultimately facilitation of more home-based monitoring, recovery, and
long-term care.
Concern over potential EMI with medical devices due to RF emissions, however, has prompted many
healthcare organizations around the world to enact broad precautionary policies restricting wireless equipment
throughout their facilities. Other healthcare organizations have implemented policies ranging from selective
restrictions on where mobile wireless equipment can operate to relatively unrestricted and unmanaged use.
While overly restrictive policies may act as obstacles limiting the benefit that wireless technology can bring to
healthcare, unmanaged use may expose patients to potentially significant and unnecessary hazards.
Table 1 — Geographical region of use, transmitted frequency and expected output power for common
wireless technologies used in healthcare facilities
Intended
Type of device Transmitted frequency Maximum transmit power
application
Wireless W-LAN (Local
40 mW [5,15–5,25 GHz]
data Area High Rate Local
802.11a 5,15–5,8 GHz 200 mW [5,25–5,35 GHz]
network Networks — Area Network
800 mW [5,72–5,82 GHz]
devices
WiFi)
typical app's: constant ~10 mW,
2,4-2,462 GHz (North America), but spec allows for:
Medium Rate Local
2,412-2,472 GHz (Europe), 1 W [US]
 802.11b
Area Network
2,471-2,497 GHz (Japan) 100 mW [Europe]
10 mW/MHz [Japan]
typical app's: constant ~10 mW,
but spec allows for:
High Rate Local 2,4–2,48 GHz (US, Europe,
1 W [US],
 802.11g
Area Network Japan)
100 mW [Europe],
10 mW/MHz [Japan]
2,4-2,48 GHz (North America &
Europe), Powerclass I: 100 mW
W-PAN
Bluetooth / Streaming Data,
2,447-2,473 GHz (Spain), Powerclass II: 2,5-10 mW
(Personal Area
802.15.1 Cable Replacement
Networks)
2,448-2,482 GHz (France), Powerclass III: 1 mW
2,473-2,495 GHz (Japan)
Streaming Video, ~0,6 mW spread over 100's
 802.15.3a UWB in 3 to 10 GHz band
Data and Voice of MHz
typical app's: constant ~1 mW,
2,4-2,48 GHz (North America &
but spec allows for:
Sensor Networks,
Europe),
Zigbee / 80
1 W [US],
 Low-Latency
2,412-2,472 GHz (Europe),
2.15.4
Data/Control 100 mW [Europe],
2,471-2,497 GHz (Japan)
10 mW/MHz [Japan]
Fixed Broadband
W-MAN Wireless Access
802.16a
2-11 GHz in unlicensed (e.g. 5,8 GHz) and licensed (e.g. 10,5, 25, 26,
(Metropolitan Systems (Video +
(fixed) 31, 38 and 39 GHz) bands
Area Networks)
simultaneous voice
& data)
Mobile
(UNLICENSED &
licensed)
Broadband Wireless
802.16e 2-11 GHz in unlicensed (e.g. 5,8 GHz) and licensed (e.g. 10,5, 25, 26,

(mobile) Access Systems 31, 38 and 39 GHz) bands
(Video +
simultaneous voice
& data)
Mobile (LICENSED)
Broadband Wireless
Access Systems
 802.20 licensed bands below 3,5 GHz
(Video +
simultaneous voice
& data)
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ISO/TR 21730:2005(E)
Table 1 (continued)
Intended
Type of device Transmitted frequency Maximum transmit power
application
Wired Network 802.3 Hard Line Ethernet (hard line)
AMPS 824-849 MHz (US),
NMT 453-458 MHz (Europe),
Mobile 1st Generation WAN Mobile AVG PWR: 0,6-1 watt down to
Analogue
Phones Technologies Communication ~6 mW in steps of -4dB
TACS 890-915 MHz (Europe),
JTACS 832-925 MHz (Japan)
GSM 824-849 & 1850-1910 MHz
(US),
GSM 890-915 & 1710-1785 MHz
(Europe, Asia),
2nd Generation
WAN Mobile AVG PWR: 200-600 mW down to
(Digital) TDMA iDEN 806-824 MHz (US),
Communication 20-2 mW in steps of -1 to -4 dB
Technologies
Tetra 380-400, 410-430, 450-470
& 805-870 MHz (Europe),
PDC 810-826 & 1429-1453 MHz
(Japan)
CDMA 824-849 &
1850-1910 MHz (US),
WAN Mobile AVG PWR: 250 mW to +1 uW in
 CDMA
Communication J-CDMA 832-925 MHz (Japan), 1dB steps
K-PCS 1750-1870 MHz (Korea)
3rd Generation
1,92-1,98 MHz (Europe,Asia),
WAN Mobile AVG PWR: 250 mW to u 1 mW
(IMT-2000) UMTS
Communication 1,7-2 GHz (US) in steps of 0,25-1 dB
Technologies
824-849, 1850-1910 MHz &
1,7-2 GHz (US);
WAN Mobile AVG PWR: 250 mW to u 1 mW
 CDMA-2000
Communication in steps of 0,25-1 dB
890-915 & 1750-1780 MHz &
1,92-1,98 GHz (Europe, Asia)
2-way WAN Text
 152-159, 454-460, 902-928 MHz 1 W (in short bursts)
pagers Messaging
Analogue 27, 40-49, 900 MHz &
2,4, 5,8 GHz (US),
Analogue and Spread Spectrum Spectralink 2,4 GHz (US, AVG PWR: constant 10 mW,
Cordless Phones
Technologies Europe), some units up to 1 W
CT-1 30-41, 72,8-73, 885, 914,
960 MHz & 1,7-1,8 GHz (Europe)
DECT 1880-1900 MHz (Europe),
CT2, CT3 864-868 & AVG PWR: constant 10 mW,
 TDMA
944-948 MHz (Europe), PEAK PWR: constant 250 mW
PHS 1895-1918 (Japan)
VoIP / 802.1 LAN Mobile
 2,4-2,462 GHz AVG PWR: constant 10 mW
1b Communication
FCC Periodic and continuous
Low-Power Radio
Short Range Devices 15.231, transmissions, 300-900, 2400, AVG PWR: 0,1 to 1 mW
Links
FCC 15.249 5800 MHz
ETSI 300 22 Low-Power Radio Periodic and continuous
 AVG PWR: 10 to 25 mW
0-1 Links transmissions, 400 and 800 MHz
JPN ARIB Low-Power Radio Periodic and continuous
 AVG PWR: 1 and 10 mW
T-67 Links transmissions, 426-449 MHz

3.2 The risk of patient harm due to EMI
The uncontrolled use of mobile wireless equipment by individuals visiting and working in healthcare facilities
has steadily increased, regardless of existing healthcare organization policy. However, the level of risk for
accidental EMI events from government and other non-profit health agency sources appears to be relatively
small [5]-[7], although underreporting of such events may be substantial. Anecdotal observations of suspected
EMI incidents with ECG and EEG machines, apnea monitors, ventilators and radiant warmers, infusion pumps,
wheelchairs, and other devices have been reported or referred to in a number of publications [5]-[18]. Ad hoc

test studies [19]-[30], [44] have confirmed that interference effects can be precipitated by certain wireless
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ISO/TR 21730:2005(E)
transmitters in susceptible medical devices, although this generally requires extreme conditions (transmission
at higher power levels, close proximity, for extended periods of time) that may not be common during normal
use. In RF transmitters that operate at constant output power of 100 milliwatts or less, significant interference
effects were not observed [45], [46].
Although medical device manufacturers generally comply with a 10-V/m immunity level against interference
from relevant RF emissions in the design of new life-critical devices, many mobile wireless handsets exceed
the 10-V/m limit when operating at maximal power and in close proximity. In addition, this immunity level is
only recommended in some countries and may be waived with appropriate exemptions. Further, many older
medical devices still in use may not have been constructed to the same immunity level. Despite this
apparently uncommon but potentially serious level of risk due to unmanaged mobile wireless handset use,
most mobile wireless equipment can operate in a fully compatible manner throughout a healthcare facility,
even where potentially sensitive medical devices are used, if comprehensive management procedures are
implemented.
3.3 Existing relevant standards and recommendations

IEC has published a standard (IEC 60601-1-2) [32] recommending that “all life-supporting medical electrical
equipment and systems be immune to field strengths of 10 V/m” and “medical electrical equipment and
systems that are not life-supporting be immune to field strengths of 3 V/m in the frequency range 80 MHz to
2,5 GHz”. This is the collateral to the general safety standard for medical electrical equipment
(IEC 60601-1) [30], based upon basic EMC immunity standards that were developed by IEC Technical
Committee (TC) 77 (EMC). IEC 60601-1-2 also sets limits for emissions and immunity test levels for
electrostatic discharge (ESD), conducted radiofrequency electromagnetic fields, bursts and surges largely
based upon CISPR emissions and TC 77 immunity standards. Although many medical device manufacturers
comply with recommended immunity guidelines, there is no government regulation enforcing these
recommendations in certain parts of the world, including the United States. Further, many older medical
devices still in use in healthcare facilities were not designed or tested to the current immunity levels. Also, the
IEC standard permits medical equipment and systems to meet lower immunity levels, with appropriate
justification [32], and 60601-1-2 Annex AAA states “… it is expected that some PATIENT-COUPLED
EQUIPMENT and SYSTEMS will use as a justification for a lower IMMUNITY COMPLIANCE LEVEL the fact
that some physiological signals can be substantially below those induced by a field strength of 3 V/m”.
The European Community has issued a set of medical device directives to further ensure compliance with
electromagnetic immunity for devices operating in Europe. Directive 93/42/EEC [34] specifies immunity
requirements for external medical devices based upon an EMI risk classification scheme of low, medium, and
high. Article 2(a) of this directive incorporates, as an integral part, or as an accessory: (a) a medical device
within the meaning of Article 1 of Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices (15), or (b) an active implantable medical device within the meaning of Article 1 of Council
Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to
active implantable medical devices (16), the apparatus shall be governed by this Directive, without prejudice
to the application of Directives 93/42/EEC and 90/385/EEC to medical devices and active implantable medical
devices, respectively. The horizontal (general) directive [35] regarding medical device
...