ISO/TR 21730:2007
(Main)Health informatics — Use of mobile wireless communication and computing technology in healthcare facilities — Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
Health informatics — Use of mobile wireless communication and computing technology in healthcare facilities — Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
ISO/TR 21730:2007 provides guidance for the deployment, use and management of mobile wireless communication and computing equipment in healthcare facilities in a way that promotes effective electromagnetic compatibility (EMC) among the wireless technology and active medical devices through mitigation of potential hazards due to electromagnetic interference (EMI). The recommendations given 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 facilities. In addition, suggestions are included for selective restrictions in cases where healthcare organizations have decided that comprehensive management procedures are not feasible, practical or desirable at the present time. The recommendations herein distinguish between wireless technology controlled by the facility and used by doctors and staff for healthcare-specific communication and health informatics transport versus non-controlled (personal) mobile wireless equipment randomly brought into the facility by visitors, patients or the healthcare organization workforce.
Informatique de santé — Utilisation des communications mobiles sans fil et des technologies informatisées dans les structures de soins — Recommandations pour la compatibilité électromagnétique (gestion des interférences électromagnétiques non intentionnelles) avec les dispositifs médicaux
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TECHNICAL ISO/TR
REPORT 21730
Second edition
2007-02-15
Health informatics — Use of mobile
wireless communication and computing
technology in healthcare facilities —
Recommendations for electromagnetic
compatibility (management of
unintentional electromagnetic
interference) with medical devices
Informatique de santé — Utilisation des communications mobiles sans
fil et des technologies informatisées dans les structures de soins —
Recommandations pour la compatibilité électromagnétique (gestion des
interférences électromagnétiques non intentionnelles) avec les
dispositifs médicaux
Reference number
ISO/TR 21730:2007(E)
©
ISO 2007
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ISO/TR 21730:2007(E)
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ISO/TR 21730:2007(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 .1
3 Current status of management of electromagnetic interference.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 EMC with medical devices and minimization of EMI risk .8
4 Recommendations.9
4.1 General recommendations .9
4.2 Responsibility within healthcare facilities .10
4.3 Inventory within healthcare facilities.10
4.4 Testing within healthcare facilities .11
4.5 Controlled use within healthcare facilities.12
4.6 Non-controlled use within healthcare facilities .13
4.7 RF emissions from network sources.14
4.8 Medical devices within healthcare facilities .14
Annex A (informative) RF technologies .15
Bibliography .34
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ISO/TR 21730:2007(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 the 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 Technical Report is to be regarded as a 'living document' and
comments for improvement will therefore be welcomed.
This second edition of ISO/TR 21730 cancels and replaces the first edition (ISO/TR 21730:2005), which has
been technically revised.
ISO/TR 21730 strongly parallels AAMI TIR No.18, which provides similar recommendations for wireless
equipment in healthcare facilities. Many of the recommendations developed within this TR are directly built
upon the foundation of earlier documents, such as AAMI TIR No.18 and ANSI/IEEE C63.18.
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ISO/TR 21730:2007(E)
Introduction
Worldwide, healthcare facilities are recognizing the need to incorporate new technology and provide better
point-of-care information to improve healthcare delivery, while reducing medical errors. Computing
technologies, electronic medical record systems, and seamless access to information using wireless
communication can 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.x local area networks, 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 the
use of personal mobile phones and other wireless devices increasingly valuable, especially in times of crisis.
Previously, no uniform international guidelines existed for the appropriate deployment, use and management
of mobile wireless communication and computing technology within healthcare facilities to address
electromagnetic compatibility (EMC) with medical devices and mitigate potential electromagnetic interference
(EMI). Although the recently approved second edition of IEC 60601-1-2 (IEC 60601-1-2:2001) specifies
general immunity levels of 3 V/m for medical equipment and systems that are not life-supporting, and 10 V/m
for life-supporting medical equipment and systems, manufacturers are allowed to justify lower levels and there
is no consistent international regulation enforcing this standard. In addition, many mobile wireless transmitters
exceed these field strength thresholds when operating at their upper power limits and in close proximity.
Finally, there are a number of older medical devices still in use that have not been designed or tested with the
above immunity considerations in mind.
At present, there appears to be a range of inconsistent policies among healthcare organizations with regards
to EMC, mobile wireless systems and management procedures. At one extreme, overly-restrictive policies
may inadvertently act as obstacles to the deployment of beneficial technology. At the other extreme, the
unmanaged use of wireless electromagnetic radiation emitters 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 the 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, while providing
necessary and sufficient safeguards against undesired and unintended risks of EMI.
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 may be
appropriate that restrict use of wireless equipment in areas where potentially susceptible medical devices are
in routine operation. Such restrictive policies might be facilitated by offering numerous and easily accessible
alternative areas where the use of mobile wireless equipment is permitted. For mobile wireless equipment that
is provided to doctors and staff under more controlled conditions, operation throughout the healthcare facility
(even in areas where potentially susceptible medical devices are used) 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 and create effective EMC among medical
devices and wireless technology.
Because most mobile wireless communication and computing systems can be effectively managed for EMC
with medical devices, the choice of wireless technology to be deployed in a healthcare facility and managed in
a dedicated manner should be based upon the solution that best addresses the needs of the organization and
benefit for patients, not on the potential of specific RF transmitter types to cause EMI when used under non-
controlled conditions.
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TECHNICAL REPORT ISO/TR 21730:2007(E)
Health informatics — Use of mobile wireless communication
and computing technology in healthcare facilities —
Recommendations for electromagnetic compatibility
(management of unintentional electromagnetic interference)
with medical devices
1 Scope
This Technical Report provides guidance for the deployment, use and management of mobile wireless
communication and computing equipment in healthcare facilities in a way that promotes effective
electromagnetic compatibility (EMC) among the wireless technology and active medical devices through
mitigation of potential hazards due to electromagnetic interference (EMI). The recommendations given
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 facilities. In addition, suggestions
are included for selective restrictions in cases where healthcare organizations have decided that
comprehensive management procedures are not feasible, practical or desirable at the present time. The
recommendations herein distinguish between wireless technology controlled by the facility and used by
doctors and staff for healthcare-specific communication and health informatics transport versus non-controlled
(personal) mobile wireless equipment randomly brought into the facility by visitors, patients or 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
relative ratio, one-tenth of the common logarithm of the ratio of relative powers, equal to 0,1 B (bel)
NOTE 1 The ratio in decibels equals 10 lg (P /P ).
10 1 2
NOTE 2 Decibels as above, but relative to a fixed 1 mW of power, are sometimes indicated as dBm.
2.2 Abbreviated terms
ASHE American Society for Healthcare Engineering
AAMI Association for the Advancement of Medical Instrumentation
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ISO/TR 21730:2007(E)
AHA American Hospital Association
AMA American Medical Association
ANSI American National Standards Institute
CDRH Center for Devices and Radiological Health, Department within FDA (US)
CISPR International Special Committee on Radio Interference
COMAR IEEE Committee on Man and Radiation
ECG Electrocardiogram
EEG Electroencephalogram
EM Electromagnetic
EMC Electromagnetic compatibility
EMD Electromagnetic disturbance
EMI Electromagnetic interference
ESD Electrostatic discharge
FDA Food and Drug Administration (US)
IEC International Electrotechnical Commission
IEEE Institute for Electrical and Electronics Engineers
ISM Industrial, Scientific, Medical
IVDs In vitro diagnostic devices
JCAHO Joint Commission on Accreditation of Healthcare Organizations
LAN Local Area Network, including 802.11b and 802.11a systems
MHRA Medicines and Healthcare Products Regulatory Agency (UK)
PAN Personal Area Network, including 802.15.1 (Bluetooth), 802.15.4 (Zigbee), 802.15.3a, etc.
PDA Personal digital assistant
R&TTE Radio and Telecommunications Terminal Equipment
RF Radiofrequency, classically defined as ranging from a few kHz - 300 GHz
Rx Reception, received RF signal
TIR Technical informational report
Tx Transmission, transmitted RF signal
UWB Ultra-wideband, refers to RF transmissions spread over at least 500 MHz of spectrum or a fractional
bandwidth of > 0,2, with a very low spectral density at any given frequency (−41,3 dBm/MHz)
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ISO/TR 21730:2007(E)
V/m Volts per metre, a measure of RF electrical field strength
WiFi Wireless Fidelity Network system
3 Current status of management of electromagnetic interference
3.1 Mobile wireless equipment in healthcare facilities
The use of mobile wireless equipment by medical healthcare staff to provide point-of-care communication and
patient information is increasingly being recognized as required to reduce medical errors and to improve
healthcare delivery. Visitors and patients are likewise finding the use of personal mobile (i.e. cellular) phones
and wireless devices increasingly valuable, especially in times of crisis. Such wireless devices might include
[1]
mobile phones, handheld computers/PDAs, WiFi/IEEE 802.11.a/b/g local area networks and wireless
[2]
modems for laptop computers, personal area networks including IEEE 802.15.1 (Bluetooth) / IEEE 802.15.4
[3]
(Zigbee) /IEEE 802.15.3a (UWB), two-way pagers, two-way 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 Industrial, Scientific, Medical (ISM) bands at 900 MHz and 2,4 GHz, 5,2 GHz and 5,8 GHz as is
the case with cordless phones and wireless data network equipment. From an RF signal perspective, mobile
wireless transmitters can employ either simple analog 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 IEEE 802.11, IEEE 802.15, and most cordless phone-type systems that
transmit constantly at relatively lower power (< 10 mW). 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 or more (1 W to 5 W).
The third category includes dynamically power-controlled equipment that can transmit at levels between a few
milliwatts and 1 W to 2 W, based upon the existing network signal strength at that particular location and time.
This Technical Report does not consider in detail the growing number of RFID tags making their way into
healthcare. Although such tags and their corresponding readers may transmit RF in either HF (13,56 MHz) or
UHF (915 MHz) bands, the amount of energy emitted is often low although long range readers can transmit at
up to 10 W. More importantly, they are not considered herein as mainstream communication or computing
technology, and are generally used for asset tracking and related functions.
An Institute of Medicine (IOM) report has estimated that common medical errors may contribute to between
[4]
44 000 and 98 000 deaths per year in the US , with a similar percentage suggested for the UK and Australia.
The estimated US number was further increased to 195 000 deaths per year in a recent report by
Healthgrades. Wireless technology has the potential to provide untethered and improved, rapid and robust
communication and access to patient data, test results, records and medical reference at the point-of-care.
These benefits may further help to reduce cost-charging errors, a reduction in cost and maintenance of
land-line phone systems, and, potentially, facilitation of more home-based monitoring, recovery and long-term
care.
Concern over potential EMI with medical devices due to radiofrequency (RF) emissions, however, has
prompted many healthcare organizations around the world to enact broad precautionary policies restricting
wireless equipment throughout their facilities. Some 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 of RF emitters may expose patients to potentially
significant and unnecessary hazards.
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ISO/TR 21730:2007(E)
Table 1 — Current and developing wireless technologies that may be used in healthcare facilities
Intended
Type of device Transmitted frequency (Tx) Maximum transmit power
application
Wireless W-LAN (Local 802.11a High Rate Local 5,15 to 5,8 GHz 40 mW [5,15 to 5,25 GHz]
data Area Area Network
200 mW [5,25 to 5,35 GHz]
network Networks —
800 mW [5,72 to 5,82 GHz]
devices WiFi)
802.11b Medium Rate Local 2,4 to 2,462 GHz (North typical app's: constant ~10 mW,
Area Network America), 2,412 to 2,472 GHz but spec allows for:
(Europe), 2,471 to 2,497 GHz
1 W [US]
(Japan)
100 mW [Europe]
10 mW/MHz [Japan]
802.11g High Rate Local 2,4 to 2,48 GHz (US, Europe, typical app's: constant ~10 mW,
Area Network Japan) but spec allows for: 1 W [US],
100 mW [Europe], 10 mW/MHz
[Japan]
W-PAN Bluetooth / Streaming Data, 2,4 to 2,48 GHz (North America & Powerclass I: 100 mW
(Personal Area 802.15.1 Cable Replcmnt Europe), 2,447 to 2,473 GHz
Powerclass II: 2,5 to 10 mW
Networks) (Spain), 2,448 to 2,482 GHz
Powerclass III: 1 mW
(France), 2,473 to 2,495 GHz
(Japan)
802.15.3a Streaming Video, UWB in 3 to 10 GHz band ~0,6 mW spread over 100's
Data and Voice of MHz
Zigbee / Sensor Networks, 2,4 to 2,48 GHz (North America & typical app's: constant ~1 mW,
802.15.4 Low-Latency Europe), 2,412 to 2,472 GHz but spec allows for: 1 W (US),
Data/Control (Europe), 2,471 to 2,497 GHz 100 mW (Europe), 10 mW/MHz
(Japan) (Japan)
W-MAN 802.16a Fixed Broadband 2 to 11 GHz in unlicensed (e.g. Watts — potentially higher
(fixed) 5,8 GHz) and licensed bands
(Metropolitan Wireless Access transmit power in licensed bands
Area Networks) Systems (Video + as compared to more restrictive
simultaneous voice unlicensed bands
& data)
802.16e Mobile unlicensed 2 to 11 GHz in unlicensed (e.g. Watts — potentially higher
(mobile) and licensed 5,8 GHz) and licensed bands transmit power in licensed bands
Broadband Wireless as compared to more restrictive
Access Systems unlicensed bands
(Video +
simultaneous voice
& data)
802.20 Mobile (LICENSED) licensed bands below 3,5 GHz Watts
Broadband Wireless
Access Systems
(Video +
simultaneous voice
& data)
Mobile 1st Generation Analogue WAN Mobile AMPS 824 to 849 MHz (US), AVG PWR: 0,6 to1 W down to
Phones Technologies Communication NMT 453 to 458 MHz (Europe), ~6 mW in steps of −4 dB
TACS 890 to 915 MHz (Europe),
JTACS 832 to 925 MHz (Japan)
2nd Generation TDMA WAN Mobile GSM 824 to 849 & 185 to AVG PWR: 200 to 600 mW down
Communication
(Digital) 1910 MHz (US), GSM 890 to 915 to 20 to2 mW in steps of −1 to
Technologies & 1710- to 1785 MHz (Europe, −4 dB, PEAK PWR 1 to 2 W
(depending upon the technology)
Asia), iDEN 806 to 824 MHz (US),
Tetra 380 to 400, 410 to 430, 450
to 470 & 805 to 870 MHz
(Europe), PDC 810 to 826 & 1429
to 1453 MHz (Japan)
CDMA WAN Mobile CDMA 824 to 849 & 1850 to AVG PWR: 250 mW to ~1 uW in
Communication 1910 MHz (US), J-CDMA 832 to 1dB steps
925 MHz (Japan), K-PCS 1750 to
1870 MHz (Korea)
3rd Generation UMTS WAN Mobile 1,92 to 1,98 MHz (Europe, Asia), AVG PWR: 250 mW to < 1 mW in
(IMT-2000) Communication 1,7 to 2 GHz (US) steps of 0,25 - 1 dB
Technologies
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ISO/TR 21730:2007(E)
Table 1 (continued)
Intended
Type of device Transmitted frequency (Tx) Maximum transmit power
application
CDMA- WAN Mobile 824 to 849, 1850 to 1910 MHz & AVG PWR: 250 mW to < 1 mW in
2000 Communication 1,7 to 2 GHz (US); 890 to 915 & steps of 0,25 to 1 dB
1750 to 1780 MHz & 1,92 to
1,98 GHz (Europe, Asia)
Two-way pagers WAN Text 152 to 159, 454 to 460, 902 to 1 W (in short bursts)
Messaging 928 MHz
Cordless Phones Analog and Spread Spectrum Analog 27, 40 to 49, 900 MHz & AVG PWR: constant 10 mW,
Technologies some units up to 1 W
2,4, 5,8 GHz (US), Spectralink
2,4 GHz (US, Europe), CT-1 30-
41, 72,8-73, 885, 914, 960 MHz &
1,7-1,8 GHz (Europe)
TDMA DECT 1880-1900 MHz (Europe), AVG PWR: constant 10 mW,
CT2, CT3 864-868 & 944- PEAK PWR: 250 mW
948 MHz (Europe), PHS 1895-
1918 (Japan)
VoIP / LAN Mobile 2,4 to 2,462 GHz AVG PWR: constant 10 mW
802.11b Communication
Short Range Devices FCC Low-Power Radio Periodic and continuous AVG PWR: 0,1 to 1 mW
15.231, Links transmissions, 300 to 900, 2400
FCC to 5800 MHz
15.249
ETSI 300 Low-Power Radio Periodic and continuous AVG PWR: 10 to 25 mW
220-1 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 to 449 MHz
a
Wired Network 802.3 Hard Line Ethernet (hard line alternative to wireless)
a
Although not a “wireless” technology, the “wired” Ethernet is the current standard being replaced by various wireless technologies
and is included in the table for comparison.
3.2 The risk of patient harm due to EMI
The non-controlled/unmanaged use of mobile wireless equipment by individuals visiting or working in
healthcare facilities has steadily increased, regardless of existing healthcare organization policy. However,
published reports suggest that the level of risk for accidental EMI events from government and other non-profit
[5]-[8]
health agency sources appears to be relatively small , although underreporting of such events may be
substantial. Anecdotal observations of suspected EMI events or incidents with ECG and EEG machines,
apnoea monitors, ventilators and radiant warmers, infusion pumps, wheelchairs and other devices have been
[5]-[19] [20]-[31], [45]
reported or referred to in a number of publications . Ad hoc test studies have confirmed that
EM interference effects can be caused by certain wireless transmitters in susceptible medical devices,
although this generally requires specific conditions (transmission at higher power levels, close proximity, for
extended periods of time) that may not be common during normal use. For RF transmitters that operate at
[46], [47]
constant output power of 100 mW or less, significant interference effects were rare .
Although the recently approved second edition of IEC 60601-1-2 specifies general immunity levels of 3 V/m
for medical equipment and systems that are not life-supporting, and 10 V/m for life-supporting medical
equipment and systems, manufacturers in the US and many other countries are allowed to justify lower levels
and there is no consistent international regulation enforcing this standard. Many mobile wireless handsets
exceed the 3 V/m and 10 V/m limits when operating at maximum power and in close proximity. Further, older
medical devices still in use may not have been constructed or tested to the same EM immunity level. Despite
the potentially serious level of risk due to unmanaged mobile wireless handset use, most mobile wireless
equipment might be allowed to operate, even where potentially susceptible medical devices are used, if
comprehensive management procedures were implemented.
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ISO/TR 21730:2007(E)
3.3 Existing relevant standards and recommendations
The International Electrotechnical Commission (IEC) has published a series of standards (IEC 61000-x-x) that
deal with general EMI mitigation and testing requirements. Relevant sections of this general EMI series apply.
[33]
The IEC has also published a more relevant standard (IEC 60601-1-2) with respect to medical device
interactions with external RF transmitting equipment that recommends life-supporting medical electrical
equipment and systems be immune to field strengths of 10 V/m, and those that are not life-supporting be
immune to field strengths of 3 V/m in the frequency range 80 MHz to 2,5 GHz. Also, medical-equipment
manuals require users to maintain minimal separations between various radio-frequency sources and medical
devices. This is the collateral to the general safety standard for medical electrical equipment
[34]
(IEC 60601-1) , 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 radio-frequency electromagnetic fields, bursts, and surges largely
based upon CISPR emissio
...
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