ETSI EN 303 203 V2.1.1 (2015-11)

Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU

REN/ERM-TG30-311

Naprave kratkega dosega (SRD) - Medicinska omrežja za merjenje parametrov človeškega telesa (MBANs), ki delujejo v frekvenčnem območju od 2483,5 MHz do 2500 MHz - Harmonizirani standard, ki zajema bistvene zahteve člena 3.2 direktive 2014/53/EU

Ta dokument vsebuje zahteve za dokaz, da je medicinsko omrežje za merjenje parametrov človeškega telesa (MBAN) »... sestavljeno tako, da učinkovito uporablja in tudi podpira učinkovito uporabo radijskega spektra, tako da ne pride do škodljivega motenja« (člen 3.2 Direktive 2014/53/EU) [i.3]. Ta dokument ne vključuje nujno vseh zahtev, ki bi jih lahko potreboval uporabnik, in ne predstavlja nujno najboljšega mogočega delovanja.
Tipi naprav, ki lahko spadajo v okvir medicinskih omrežij za merjenje parametrov človeškega telesa (MBAN), so medicinski senzorji na telesu in zunaj telesa, naprave za spremljanje bolnikov in medicinski aktuatorji, ki jih zajema direktiva o medicinskih pripomočkih (Direktiva 93/42/EGS [i.5]).
Ta dokument velja za naslednje uporabe MBAN-ov, ki so namenjeni za notranjo uporabo:
• MBAN-i, ki se uporabljajo v zdravstveni ustanovi;
• MBAN-i, ki se uporabljajo na domu bolnika.
Ta dokument vsebuje naslednje osnovne tehnične karakteristike radijske opreme MBAN-ov, ki so obravnavane tudi v prilogi 2 dokumenta CEPT/ERC/REC 70-03 [i.2]:
• MBAN-i v zdravstvenih ustanovah z maksimalno 1 mW ekvivalentne izotropne sevane moči (e.i.r.p.) ter obratovalnim ciklom, ki ne presega 10 % emisije maksimalne pasovne širine 3 MHz;
• MBAN-i v domovih bolnikov z maksimalno 10 mW ekvivalentne izotropne sevane moči (e.i.r.p.) ter obratovalnim ciklom, ki ne presega 2 % emisije maksimalne pasovne širine 3 MHz.

General Information

• Status: Published
• Publication Date: 11-Aug-2016
• Technical Committee: ERM TG30 - ERM Wireless Medical Devices
• Current Stage: 12 - Citation in the OJ
• Due Date: 09-Feb-2016
• Completion Date: 12-Aug-2016
• Ref Project: SIST EN 303 203 V2.1.1:2016 - Short Range Devices (SRD) - Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU

Standards Content (Sample)

Draft ETSI EN 303 203 V2.1.0 (2015-07)

HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Medical Body Area Network Systems (MBANSs)
operating in the 2 483,5 MHz to 2 500 MHz range;
Harmonised Standard covering the essential requirements
of article 3.2 of the Directive 2014/53/EU

2 Draft ETSI EN 303 203 V2.1.0 (2015-07)

Reference
REN/ERM-TG30-311
Keywords
health, network, radio, regulation, SRD, system
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3 Draft ETSI EN 303 203 V2.1.0 (2015-07)
Contents
Intellectual Property Rights . 6
Foreword . 6
Modal verbs terminology . 6
Introduction . 6
1 Scope . 8
2 References . 8
2.1 Normative references . 8
2.2 Informative references . 8
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 11
3.3 Abbreviations . 11
4 Technical requirements and specifications . 12
4.1 Environmental profile . 12
4.2 Conformance requirements . 12
4.2.1 Transmitter requirements . 12
4.2.1.1 Frequency Error . 12
4.2.1.1.1 Definition. 12
4.2.1.1.2 Limits . 12
4.2.1.1.3 Conformance . 12
4.2.1.2 Emission bandwidth . 12
4.2.1.2.1 Definition. 12
4.2.1.2.2 Limits . 12
4.2.1.2.3 Conformance . 12
4.2.1.3 Effective isotropic radiated power . 12
4.2.1.3.1 Definition. 12
4.2.1.3.2 Limits . 12
4.2.1.3.3 Conformance . 13
4.2.1.4 Spurious emissions . 13
4.2.1.4.1 Definition. 13
4.2.1.4.2 Limits . 13
4.2.1.4.3 Conformance . 13
4.2.1.5 Out-of-band emissions . 13
4.2.1.5.1 Definition. 13
4.2.1.5.2 Limits . 13
4.2.1.5.3 Conformance . 13
4.2.1.6 Frequency stability under low voltage conditions . 14
4.2.1.6.0 Applicability . 14
4.2.1.6.1 Definition. 14
4.2.1.6.2 Limits . 14
4.2.1.6.3 Conformance . 14
4.2.1.7 Duty cycle . 14
4.2.1.7.0 General remarks. 14
4.2.1.7.1 Definition. 14
4.2.1.7.2 Limits . 14
4.2.1.7.3 Conformance . 14
4.2.2 Receiver requirements . 15
4.2.2.1 Spurious radiation . 15
4.2.2.1.1 Definition. 15
4.2.2.1.2 Limits . 15
4.2.2.1.3 Conformance . 15
4.2.2.2 Receiver blocking . 15
4.2.2.2.1 Definition. 15
4.2.2.2.2 Limits . 15
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4 Draft ETSI EN 303 203 V2.1.0 (2015-07)
4.2.2.2.3 Conformance . 15
4.2.3 Spectrum access . 15
4.2.3.0 General requirements . 15
4.2.3.1 LBT threshold power level . 17
4.2.3.1.1 Definition. 17
4.2.3.1.2 Limits . 17
4.2.3.1.3 Conformance . 17
4.2.3.2 Monitoring system bandwidth . 17
4.2.3.2.0 General remarks. 17
4.2.3.2.1 Definition. 17
4.2.3.2.2 Limits . 17
4.2.3.2.3 Conformance . 17
4.2.3.3 Minimum channel monitoring period . 17
4.2.3.3.0 General remarks. 17
4.2.3.3.1 Definition. 17
4.2.3.3.2 Limits . 17
4.2.3.3.3 Conformance . 18
4.2.3.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, P . 18
Th
4.2.3.4.0 General requirements . 18
4.2.3.4.1 Conformance . 18
4.3 Mechanical and electrical design . 18
4.3.1 General . 18
4.3.2 Controls . 18
4.3.3 Transmitter shut-off facility . 18
5 Testing for compliance with technical requirements . 18
5.1 Environmental conditions for testing . 18
5.1.0 General requirements . 18
5.1.1 Presentation for testing . 19
5.1.1.0 General provisions . 19
5.1.1.1 Choice of model for testing . 19
5.1.1.2 Spurious emission testing for composite equipment . 19
5.1.1.3 Testing of equipment with alternative power levels . 19
5.1.1.4 Presentation of equipment that does not have an external RF connector (equipment with an
integral antenna) . 20
5.1.1.4.1 Equipment with a permanent or temporary internal antenna connector . 20
5.1.1.4.2 Equipment with a temporary antenna connector . 20
5.1.2 Declarations by the applicant . 20
5.1.3 Auxiliary test equipment . 20
5.1.4 Test conditions . 20
5.1.4.1 Normal and extreme test conditions . 20
5.1.4.2 Test power source . 20
5.1.4.2.0 General requirements . 20
5.1.4.2.1 External test power source . 20
5.1.4.2.2 Internal test power source . 21
5.1.4.3 Normal test conditions . 21
5.1.4.3.1 Normal temperature and humidity . 21
5.1.4.3.2 Normal test power source . 21
5.1.4.4 Extreme test conditions . 21
5.1.4.4.1 Extreme temperatures . 21
5.1.4.4.2 Extreme test source voltages . 23
5.1.4.5 Normal test signals and test modulation. 23
5.1.4.5.0 General requirements . 23
5.1.4.5.1 Normal modulation test signals for data . 23
5.1.4.6 Antennas . 23
5.1.4.7 Test fixture . 23
5.1.4.8 Test sites and general arrangements for radiated measurements . 24
5.1.4.9 Modes of operation of the transmitter . 24
5.1.4.10 Measuring receiver . 24
5.1.4.11 General remarks on configuration for transmitter measurements . 25
5.1.4.12 General remarks on configuration for receiver measurements . 25
5.1.4.13 General remarks on configuration for monitoring system measurements . 26
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5 Draft ETSI EN 303 203 V2.1.0 (2015-07)
5.2 Interpretation of the measurement results . 26
5.3 Methods of measurement . 27
5.3.1 Frequency error . 27
5.3.1.0 General requirements . 27
5.3.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 27
5.3.1.2 Method of measurement for systems with a modulated output frequency . 27
5.3.2 Emission bandwidth . 28
5.3.3 Effective isotropic radiated power . 28
5.3.4 Transmitter spurious emis sions . 29
5.3.5 Out-of-band emissions . 30
5.3.6 Frequency stability under low voltage conditions . 32
5.3.7 Receiver spurious emissions . 32
5.3.8 LBT threshold power level . 33
5.3.8.0 General remarks . 33
5.3.8.1 Measurement method using frequency administration commands . 33
5.3.8.2 Results based on the above test method . 33
5.3.9 Minimum channel monitoring period . 33
5.3.9.0 General remarks . 33
5.3.9.1 Measurement method using frequency administration commands . 33
5.3.9.2 Results based on the above test method . 34
5.3.10 Channel access based on ambient levels relative to the calculated access LBT threshold level, P . 34
Th
5.3.10.0 Initial steps . 34
5.3.10.1 Accessing an unoccupied channel . 34
5.3.10.2 Results accessing an unoccupied channel . 34
5.3.10.3 Accessing the Least Interfered Channel . 34
5.3.10.4 Results accessing the Least Interfered Channel . 34
5.3.11 Receiver blocking . 34
5.3.11.0 General remarks . 34
5.3.11.1 Measurement method using frequency administration commands . 34
5.3.11.2 Results based on the above test method . 35
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 36
Annex B (normative): Radiated measurements . 38
B.1 Test sites and arrangements for radiated measurements . 38
B.1.1 Outdoor test site . 38
B.1.2 Indoor test site . 38
B.1.3 Shielded anechoic test site . 39
B.2 Antennas . 41
B.2.1 Test antenna . 41
B.2.2 Substitution antenna . 41
B.3 Test practice and auxiliary test equipment . 42
B.3.0 General requirements . 42
B.3.1 Measuring distance . 42
B.3.2 Auxiliary cables . 42
Annex C (informative): Bibliography . 43
History . 44

ETSI
6 Draft ETSI EN 303 203 V2.1.0 (2015-07)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (http://ipr.etsi.org).
Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee
can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web
server) which are, or may be, or may become, essential to the present document.
Foreword
This draft Harmonised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic
compatibility and Radio spectrum Matters (ERM), and is now submitted for the combined Public Enquiry and Vote
phase of the ETSI standards EN Approval Procedure.
The present document has been prepared to provide a means of conforming to the essential requirements of Directive
2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the
Member States relating to the making available on the market of radio equipment and repealing Directive
1999/5/EC [i.3].
NOTE: The corresponding Commission's standardization request is expected shortly.
Once the present document is cited in the Official Journal of the European Union under that Directive, compliance with
the normative clauses of the present document given in table A.1 confers, within the limits of the scope of the present
document, a presumption of conformity with the corresponding essential requirements of that Directive, and associated
EFTA regulations.
The present document covers Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to
2 500 MHz range, as described in the systems reference document for the equipment, ETSI TR 101 557 [i.1].

Proposed national transposition dates
Date of latest announcement of this EN (doa): 3 months after ETSI publication
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 6 months after doa
Date of withdrawal of any conflicting National Standard (dow): 18 months after doa

Modal verbs terminology
In the present document "shall", "shall not", "should", "should not", "may", "need not", "will", "will not", "can" and
(Verbal forms for the expression of
"cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules
provisions).
"must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation.
Introduction
The present document is part of a set of standards developed by ETSI and is designed to fit in a modular structure to
cover all radio and telecommunications terminal equipment within the scope of the Radio Equipment Directive
(RE-D) [i.3]. The modular structure is shown in ETSI EG 201 399 [i.4].
ETSI
7 Draft ETSI EN 303 203 V2.1.0 (2015-07)
The present document describes the technical characteristics and test and performance requirements for Medical Body
Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz frequency range.
Medical Body Area Networks are short-range low-power wireless networks, consisting of a plurality of body-worn
sensor devices and/or actuator devices and a hub device placed on/around the human body. The on-body sensor devices
are responsible for measuring key patient-specific information, such as the temperature, pulse, blood glucose level,
electrocardiogram, blood pressure level and respiratory function readings. The hub device acts as a central controller to
maintain the connections with all devices associated with its MBANS and is responsible for device
association/de-association and channel selection. The hub device also typically receives the data collected from the
various sensor devices on the body and may, depending on applications, process the data locally and/or further forward
it to a remote central station (e.g. remote nursing station) via an appropriate wired/wireless link for centralized
processing, display and storage.
Usually, MBANS devices are highly resource-constrained in terms of battery capacity, MCU capability and memory
size. Therefore, simple and low-power MBANS solutions are preferred from the application point of view. Currently,
most of mature low-power low-cost short-range radio solutions have spectrum efficiency around or less than 1 bps/Hz
and it is expected that MBANS solutions will have similar spectrum efficiency. Also to prolong battery life, MBANS
devices are expected to transmit with a limited duty cycle. The MBANS devices' duty cycle is not more than 10 % for
in-hospital applications and not more than 2 % for in-home applications.
In addition to the technical specifications, the present document provides measurement methods for MBANS equipment
which should support operation in healthcare facility mode or home mode, or both modes. These measurement methods
are to be implemented throughout the process of manufacturing and putting onto the market. Moreover, if the MBANS
equipment is required to be checked for the purpose of market surveillance, it should be tested also in accordance with
the methods of measurement specified in the present document.
The present document is structured as follows:
• Clauses 1 through 3 provide a general description of the types of equipment covered by the present document
and the definitions of terms and symbols and abbreviations used.
• Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access. The latter
are primarily designed to minimize the possibility of disturbance between MBANS equipment and other users
of the 2 483,5 MHz to 2 500 MHz frequency range.
• Clauses 5.1 and 5.2 specify the test and general conditions for testing of the equipment.
• Clause 5.3 specifies the methods of measurement for the parameters specified in clause 4, related to
transmitter, receiver, and spectrum access.
• Annex A (informative) provides an overview of the relationship between the present document and the
essential requirements of RE-D.
• Annex B (normative) gives the specifications concerning radiated measurements.
• Annex C (informative) provides bibliography.
ETSI
8 Draft ETSI EN 303 203 V2.1.0 (2015-07)
1 Scope
The present document contains requirements to demonstrate that Medical Body Area Network System (MBANS)
“…shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid
harmful interference” (article 3.2 of the Directive 2014/53/EU) [i.3]. The present document does not necessarily include
all the requirements which may be required by a user, nor does it necessarily represent the optimum performance
achievable.
The types of devices that can belong to MBANSs are on-body and off-body medical sensors, patient monitoring devices
and medical actuators covered by the Medical Device Directive (Directive 93/42/EEC [i.5]).
The present document applies to the following MBANS applications which are considered to operate indoor:
• MBANS operating in the healthcare facility.
• MBANS operating in the patient's home.
The present document contains the following basic technical characteristics of MBANS radio equipment which are also
addressed in annex 2 of CEPT/ERC/REC 70-03 [i.2]:
• Healthcare facility MBANS with 1 mW maximum e.i.r.p. and not more than 10 % duty cycle over a maximum
emission bandwidth of 3 MHz.
• Patient's home MBANS with 10 mW maximum e.i.r.p. and not more than 2 % duty cycle over a maximum
emission bandwidth of 3 MHz.
2 References
2.1 Normative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://docbox.etsi.org/Reference.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are necessary for the application of the present document.
[1] CISPR 16-2-3 (2010) +AMD1:2010+AMD2:2014: "Specification for radio disturbance and
immunity measuring apparatus and methods - Part 2-3: Methods of measurement of disturbances
and immunity - Radiated disturbance measurements".
2.2 Informative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are not necessary for the application of the present document but they assist the
user with regard to a particular subject area.
[i.1] ETSI TR 101 557: "Electromagnetic compatibility and Radio spectrum Matters (ERM); System
Reference document (SRdoc); Medical Body Area Network Systems (MBANSs) in the
1 785 MHz to 2 500 MHz range".
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9 Draft ETSI EN 303 203 V2.1.0 (2015-07)
[i.2] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.3] Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of
radio equipment and repealing Directive 1999/5/EC (RE-D).
[i.4] ETSI EG 201 399 (V3.1.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM);
A guide to the production of Harmonized Standards for application under the Radio &
Telecommunication Terminal Equipment Directive 1999/5/EC (R&TTE) and a first guide on the
impact of the Radio Equipment Directive 2014/53/EU (RED) on Harmonized Standards".
[i.5] Directive 93/42/EEC of the Council of 14 June 1993 concerning medical devices.
[i.6] CEPT/ERC/REC 74-01: "Unwanted emissions in the spurious domain".
[i.7] Recommendation ITU-T O.153: "Basic parameters for the measurement of error performance at
bit rates below the primary rate".
[i.8] ETSI TR 100 028 (V1.4.1) (12-2001): "Electromagnetic compatibility and Radio spectrum Matters
(ERM); Uncertainties in the measurement of mobile radio equipment characteristics".
3 Definitions, symbols and abbreviations
3.1 Definitions
For the purposes of the present document, the terms and definitions given in the RE-D [i.3] and the following apply:
Adaptive Frequency Agility (AFA): ability to determine and change to an unoccupied or least interfered sub-band or
channel of operation in order to maximize spectrum utilization
composite equipment: any combined equipment made of two or more individual products or functions
NOTE: The individual products or functions in composite equipment might be subject to different technical
standards.
conducted measurements: measurements that are made using a direct connection to the equipment under test
dedicated antenna: removable antenna supplied and tested with the radio equipment, designed as an indispensable part
of the equipment
duly authorized healthcare professional: physician or other individual authorized by law to provide healthcare
services using prescription medical devices
duty cycle: ratio, expressed as a percentage, of the maximum transmitter "on" time monitored over one hour, relative to
a one hour period
NOTE: See clause 4.2.1.7.
effective isotropically radiated power (e.i.r.p.): product of the power supplied to the antenna and the antenna gain in a
given direction relative to an isotropic antenna
NOTE: See clause 4.2.1.3.
effective radiated power: power radiated within the emission bandwidth of the EUT in the direction of the maximum
level under specified conditions of measurements in the presence of modulation or without modulation as appropriate
emission bandwidth: measured as the width of the signal between the points on either side of centre frequency that are
20 dB down relative to the maximum level of the modulated signal
frequency administration commands: commands, exclusively intended for testing purposes, which place the
equipment under test in a specific frequency configuration, such as a channel or sub-set of channels
frequency error: difference between the nominal frequency as measured on the equipment under test and under normal
test conditions and the frequency under extreme conditions
ETSI
10 Draft ETSI EN 303 203 V2.1.0 (2015-07)
frequency range: range of operating frequencies over which the equipment can be adjusted
NOTE: See also clause 4.2.1.1.1.
frequency stability under low voltage condition: ability of the equipment to remain on the nominal operating
frequency when the battery voltage falls below the lower extreme voltage level
NOTE: See also clause 4.2.1.6.1.
healthcare facility: hospital or other establishment where medical care is provided by authorized healthcare
professionals
healthcare facility mode: operational regime by which MBANS equipment is intended to be operated exclusively
within healthcare facilities
home mode: operational regime by which MBANS equipment is intended to be operated exclusively within patient
residences
integral antenna: permanent fixed antenna, which may be built-in, designed as an indispensable part of the equipment
LBT threshold power level: ambient signal power level above which the monitoring system selects spectrum for
MBANS transmissions according to the next available channel
Least Interfered Channel (LIC): channel, among the available channels, that has the lowest potential for causing
disturbance to or receiving disturbance from other users of the band
Listen Before Talk (LBT): combination of the listen mode followed by the talk mode
listen mode: action taken by an interrogator to detect an unoccupied sub-band or channel
medical actuator: medical device responsible for performing an action on the human body for diagnostic and/or
therapeutic purposes (e.g. an infusion pump)
MBANS hub: medical device that selects the frequency of operation, gives instructions to participating devices of the
MBANS, and controls system operation
Medical Body Area Network System (MBANS): low power radio system used for the indoor transmission of non-
voice data to and from medical devices for the purposes of monitoring, diagnosing and treating patients as prescribed by
duly authorized healthcare professionals
NOTE: A MBANS consists of one or more on-body wireless medical sensor devices and/or medical actuator
devices that can communicate with a monitoring device placed on/around the human body. Such
monitoring devices, in their role of MBANS hub, display and process physiological parameters from
MBANS devices and may also forward them (e.g. to a central nurse station) by using wired or wireless
technologies other than MBANSs. MBANS hubs control MBANS devices for the purpose of providing
monitoring, diagnosis and treatment of patients. Implantable devices are not part of MBANSs.
medical device: any instrument, apparatus, appliance, material or other article, falling under the Medical Device
Directive (Directive 93/42/EEC [i.5]), whether used alone or in combination, together with any accessories or software
for its proper functioning, intended by the manufacturer to be used for human beings in the:
• diagnosis, prevention, monitoring, treatment or alleviation of disease or injury;
• investigation, replacement or modification of the anatomy or of a physiological process;
• control of conception.
medical sensor: medical device responsible for the collection of physiological parameters for diagnostic and/or
therapeutic purposes
monitoring system: circuitry that assures conformity with the spectrum access protocol requirements based on Listen
Before Talk, Adaptive Frequency Agility and selection of the Least Interfered Channel for operation (LIC) or the
unoccupied sub-band or channel
out-of-band emissions: emissions on a frequency or frequencies immediately outside the necessary emission
bandwidth, which result from the modulation process, but excluding emissions in the spurious domain
ETSI
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.UDPHWURY(8Short Range Devices (SRD) - Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU35.240.80Uporabniške rešitve IT v zdravstveni tehnikiIT applications in health care technology33.060.99Druga oprema za radijske komunikacijeOther equipment for radiocommunicationsICS:Ta slovenski standard je istoveten z:EN 303 203 V2.1.1SIST EN 303 203 V2.1.1:2016en01-marec-2016SIST EN 303 203 V2.1.1:2016SLOVENSKI
STANDARD
HARMONISED EUROPEAN STANDARD SIST EN 303 203 V2.1.1:2016

ETSI ETSI EN 303 203 V2.1.1 (2015-11) 2
Reference REN/ERM-TG30-311 Keywords health, network, radio, regulation, SRD, system ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
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ETSI ETSI EN 303 203 V2.1.1 (2015-11) 3 Contents Intellectual Property Rights . 6 Foreword . 6 Modal verbs terminology . 6 Introduction . 7 1 Scope . 8 2 References . 8 2.1 Normative references . 8 2.2 Informative references . 8 3 Definitions, symbols and abbreviations . 9 3.1 Definitions . 9 3.2 Symbols . 11 3.3 Abbreviations . 11 4 Technical requirements and specifications . 12 4.1 Environmental profile . 12 4.2 Conformance requirements . 12 4.2.1 Transmitter requirements . 12 4.2.1.1 Frequency Error . 12 4.2.1.1.1 Definition. 12 4.2.1.1.2 Limits . 12 4.2.1.1.3 Conformance . 12 4.2.1.2 Emission bandwidth . 12 4.2.1.2.1 Definition. 12 4.2.1.2.2 Limits . 12 4.2.1.2.3 Conformance . 12 4.2.1.3 Effective isotropic radiated power . 12 4.2.1.3.1 Definition. 12 4.2.1.3.2 Limits . 12 4.2.1.3.3 Conformance . 13 4.2.1.4 Spurious emissions . 13 4.2.1.4.1 Definition. 13 4.2.1.4.2 Limits . 13 4.2.1.4.3 Conformance . 13 4.2.1.5 Out-of-band emissions . 13 4.2.1.5.1 Definition. 13 4.2.1.5.2 Limits . 13 4.2.1.5.3 Conformance . 13 4.2.1.6 Frequency stability under low voltage conditions . 14 4.2.1.6.0 Applicability . 14 4.2.1.6.1 Definition. 14 4.2.1.6.2 Limits . 14 4.2.1.6.3 Conformance . 14 4.2.1.7 Duty cycle . 14 4.2.1.7.0 General remarks. 14 4.2.1.7.1 Definition. 14 4.2.1.7.2 Limits . 14 4.2.1.7.3 Conformance . 14 4.2.2 Receiver requirements . 15 4.2.2.1 Spurious radiation . 15 4.2.2.1.1 Definition. 15 4.2.2.1.2 Limits . 15 4.2.2.1.3 Conformance . 15 4.2.2.2 Receiver blocking . 15 4.2.2.2.1 Definition. 15 4.2.2.2.2 Limits . 15 SIST EN 303 203 V2.1.1:2016

ETSI ETSI EN 303 203 V2.1.1 (2015-11) 4 4.2.2.2.3 Conformance . 15 4.2.3 Spectrum access . 15 4.2.3.0 General requirements . 15 4.2.3.1 LBT threshold power level . 17 4.2.3.1.1 Definition. 17 4.2.3.1.2 Limits . 17 4.2.3.1.3 Conformance . 17 4.2.3.2 Monitoring system bandwidth . 17 4.2.3.2.0 General remarks. 17 4.2.3.2.1 Definition. 17 4.2.3.2.2 Limits . 17 4.2.3.2.3 Conformance . 17 4.2.3.3 Minimum channel monitoring period . 17 4.2.3.3.0 General remarks. 17 4.2.3.3.1 Definition. 17 4.2.3.3.2 Limits . 17 4.2.3.3.3 Conformance . 18 4.2.3.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh . 18 4.2.3.4.0 General requirements . 18 4.2.3.4.1 Conformance . 18 4.3 Mechanical and electrical design . 18 4.3.1 General . 18 4.3.2 Controls . 18 4.3.3 Transmitter shut-off facility . 18 5 Testing for compliance with technical requirements . 18 5.1 Environmental conditions for testing . 18 5.1.0 General requirements . 18 5.1.1 Presentation for testing . 19 5.1.1.0 General provisions . 19 5.1.1.1 Choice of model for testing . 19 5.1.1.2 Spurious emission testing for composite equipment . 19 5.1.1.3 Testing of equipment with alternative power levels . 19 5.1.1.4 Presentation of equipment that does not have an external RF connector (equipment with an integral antenna) . 20 5.1.1.4.1 Equipment with a permanent or temporary internal antenna connector . 20 5.1.1.4.2 Equipment with a temporary antenna connector . 20 5.1.2 Declarations by the applicant . 20 5.1.3 Auxiliary test equipment . 20 5.1.4 Test conditions . 20 5.1.4.1 Normal and extreme test conditions . 20 5.1.4.2 Test power source . 20 5.1.4.2.0 General requirements . 20 5.1.4.2.1 External test power source . 20 5.1.4.2.2 Internal test power source . 21 5.1.4.3 Normal test conditions . 21 5.1.4.3.1 Normal temperature and humidity . 21 5.1.4.3.2 Normal test power source . 21 5.1.4.4 Extreme test conditions . 21 5.1.4.4.1 Extreme temperatures . 21 5.1.4.4.2 Extreme test source voltages . 23 5.1.4.5 Normal test signals and test modulation. 23 5.1.4.5.0 General requirements . 23 5.1.4.5.1 Normal modulation test signals for data . 23 5.1.4.6 Antennas . 23 5.1.4.7 Test fixture . 23 5.1.4.8 Test sites and general arrangements for radiated measurements . 24 5.1.4.9 Modes of operation of the transmitter . 24 5.1.4.10 Measuring receiver . 24 5.1.4.11 General remarks on configuration for transmitter measurements . 25 5.1.4.12 General remarks on configuration for receiver measurements . 25 5.1.4.13 General remarks on configuration for monitoring system measurements . 26 SIST EN 303 203 V2.1.1:2016

ETSI ETSI EN 303 203 V2.1.1 (2015-11) 5 5.2 Interpretation of the measurement results . 26 5.3 Methods of measurement . 27 5.3.1 Frequency error . 27 5.3.1.0 General requirements . 27 5.3.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 27 5.3.1.2 Method of measurement for systems with a modulated output frequency . 27 5.3.2 Emission bandwidth . 28 5.3.3 Effective isotropic radiated power . 28 5.3.4 Transmitter spurious emissions . 29 5.3.5 Out-of-band emissions . 30 5.3.6 Frequency stability under low voltage conditions . 32 5.3.7 Receiver spurious emissions . 32 5.3.8 LBT threshold power level . 33 5.3.8.0 General remarks . 33 5.3.8.1 Measurement method using frequency administration commands . 33 5.3.8.2 Results based on the above test method . 33 5.3.9 Minimum channel monitoring period . 33 5.3.9.0 General remarks . 33 5.3.9.1 Measurement method using frequency administration commands . 33 5.3.9.2 Results based on the above test method . 34 5.3.10 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh . 34 5.3.10.0 Initial steps . 34 5.3.10.1 Accessing an unoccupied channel . 34 5.3.10.2 Results accessing an unoccupied channel . 34 5.3.10.3 Accessing the Least Interfered Channel . 34 5.3.10.4 Results accessing the Least Interfered Channel . 34 5.3.11 Receiver blocking . 34 5.3.11.0 General remarks . 34 5.3.11.1 Measurement method using frequency administration commands . 35 5.3.11.2 Results based on the above test method . 35 Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 36 Annex B (normative): Radiated measurements . 37 B.1 Test sites and arrangements for radiated measurements . 37 B.1.1 Outdoor test site . 37 B.1.2 Indoor test site . 37 B.1.3 Shielded anechoic test site . 38 B.2 Antennas . 40 B.2.1 Test antenna . 40 B.2.2 Substitution antenna . 40 B.3 Test practice and auxiliary test equipment . 41 B.3.0 General requirements . 41 B.3.1 Measuring distance . 41 B.3.2 Auxiliary cables . 41 Annex C (informative): Bibliography . 42 History . 43
ETSI ETSI EN 303 203 V2.1.1 (2015-11) 6 Intellectual Property Rights IPRs essential or potentially essential to the present document may have been declared to ETSI. The information pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web server (http://ipr.etsi.org). Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web server) which are, or may be, or may become, essential to the present document. Foreword This Harmonised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document has been prepared in reply to the Commission's standardisation request Commission Implementing Decision C(2015) 5376 final of 04.08.2015 to provide a means of conforming to the essential requirements of Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment - also known as the Radio Equipment Directive [i.3]. Once the present document is cited in the Official Journal of the European Union under that Directive, compliance with the normative clauses of the present document given in table A.1 confers, within the limits of the scope of the present document, a presumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations.
The present document covers Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range, as described in the systems reference document for the equipment, ETSI TR 101 557 [i.1].
National transposition dates Date of adoption of this EN: 2 November 2015 Date of latest announcement of this EN (doa): 29 February 2016 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 August 2016 Date of withdrawal of any conflicting National Standard (dow): 31 August 2017
Modal verbs terminology In the present document "shall", "shall not", "should", "should not", "may", "need not", "will", "will not", "can" and "cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of provisions). "must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation. SIST EN 303 203 V2.1.1:2016

ETSI ETSI EN 303 203 V2.1.1 (2015-11) 7 Introduction The present document is part of a set of standards developed by ETSI and is designed to fit in a modular structure to cover all radio and telecommunications terminal equipment within the scope of the Radio Equipment Directive (RE-D) [i.3]. The modular structure is shown in ETSI EG 201 399 [i.4]. The present document describes the technical characteristics and test and performance requirements for Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz frequency range.
Medical Body Area Networks are short-range low-power wireless networks, consisting of a plurality of body-worn sensor devices and/or actuator devices and a hub device placed on/around the human body. The on-body sensor devices are responsible for measuring key patient-specific information, such as the temperature, pulse, blood glucose level, electrocardiogram, blood pressure level and respiratory function readings. The hub device acts as a central controller to maintain the connections with all devices associated with its MBANS and is responsible for device association/de-association and channel selection. The hub device also typically receives the data collected from the various sensor devices on the body and may, depending on applications, process the data locally and/or further forward it to a remote central station (e.g. remote nursing station) via an appropriate wired/wireless link for centralized processing, display and storage.
Usually, MBANS devices are highly resource-constrained in terms of battery capacity, MCU capability and memory size. Therefore, simple and low-power MBANS solutions are preferred from the application point of view. Currently, most of mature low-power low-cost short-range radio solutions have spectrum efficiency around or less than 1 bps/Hz and it is expected that MBANS solutions will have similar spectrum efficiency. Also to prolong battery life, MBANS devices are expected to transmit with a limited duty cycle. The MBANS devices' duty cycle is not more than 10 % for in-hospital applications and not more than 2 % for in-home applications.
In addition to the technical specifications, the present document provides measurement methods for MBANS equipment which should support operation in healthcare facility mode or home mode, or both modes. These measurement methods are to be implemented throughout the process of manufacturing and putting onto the market. Moreover, if the MBANS equipment is required to be checked for the purpose of market surveillance, it should be tested also in accordance with the methods of measurement specified in the present document. The present document is structured as follows: • Clauses 1 through 3 provide a general description of the types of equipment covered by the present document and the definitions of terms and symbols and abbreviations used. • Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access. The latter are primarily designed to minimize the possibility of disturbance between MBANS equipment and other users of the 2 483,5 MHz to 2 500 MHz frequency range. • Clauses 5.1 and 5.2 specify the test and general conditions for testing of the equipment. • Clause 5.3 specifies the methods of measurement for the parameters specified in clause 4, related to transmitter, receiver, and spectrum access. • Annex A (informative) provides an overview of the relationship between the present document and the essential requirements of RE-D. • Annex B (normative) gives the specifications concerning radiated measurements. • Annex C (informative) provides bibliography. SIST EN 303 203 V2.1.1:2016

ETSI ETSI EN 303 203 V2.1.1 (2015-11) 8 1 Scope The present document contains requirements to demonstrate that Medical Body Area Network System (MBANS) “…shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference” (article 3.2 of the Directive 2014/53/EU) [i.3]. The present document does not necessarily include all the requirements which may be required by a user, nor does it necessarily represent the optimum performance achievable. The types of devices that can belong to MBANSs are on-body and off-body medical sensors, patient monitoring devices and medical actuators covered by the Medical Device Directive (Directive 93/42/EEC [i.5]). The present document applies to the following MBANS applications which are considered to operate indoor: • MBANS operating in the healthcare facility. • MBANS operating in the patient's home. The present document contains the following basic technical characteristics of MBANS radio equipment which are also addressed in annex 2 of CEPT/ERC/REC 70-03 [i.2]: • Healthcare facility MBANS with 1 mW maximum e.i.r.p. and not more than 10 % duty cycle over a maximum emission bandwidth of 3 MHz. • Patient's home MBANS with 10 mW maximum e.i.r.p. and not more than 2 % duty cycle over a maximum emission bandwidth of 3 MHz. 2 References 2.1 Normative references References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. Referenced documents which are not found to be publicly available in the expected location might be found at http://docbox.etsi.org/Reference. NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee their long term validity. The following referenced documents are necessary for the application of the present document. [1] CISPR 16-2-3 (2010) +AMD1:2010+AMD2:2014: "Specification for radio disturbance and immunity measuring apparatus and methods - Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance measurements". 2.2 Informative references References are either specific (identified by date of publication and/or edition number or version number) or non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the referenced document (including any amendments) applies. NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee their long term validity. The following referenced documents are not necessary for the application of the present document but they assist the user with regard to a particular subject area. [i.1] ETSI TR 101 557: "Electromagnetic compatibility and Radio spectrum Matters (ERM); System Reference document (SRdoc); Medical Body Area Network Systems (MBANSs) in the 1 785 MHz to 2 500 MHz range". SIST EN 303 203 V2.1.1:2016

ETSI ETSI EN 303 203 V2.1.1 (2015-11) 9 [i.2] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)". [i.3] Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (RE-D). [i.4] ETSI EG 201 399 (V3.1.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM); A guide to the production of Harmonized Standards for application under the Radio & Telecommunication Terminal Equipment Directive 1999/5/EC (R&TTE) and a first guide on the impact of the Radio Equipment Directive 2014/53/EU (RED) on Harmonized Standards". [i.5] Directive 93/42/EEC of the Council of 14 June 1993 concerning medical devices. [i.6] CEPT/ERC/REC 74-01: "Unwanted emissions in the spurious domain". [i.7] Recommendation ITU-T O.153: "Basic parameters for the measurement of error performance at bit rates below the primary rate". [i.8] ETSI TR 100 028 (V1.4.1) (12-2001): "Electromagnetic compatibility and Radio spectrum Matters (ERM); Uncertainties in the measurement of mobile radio equipment characteristics". 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the terms and definitions given in the RE-D [i.3] and the following apply: Adaptive Frequency Agility (AFA): ability to determine and change to an unoccupied or least interfered sub-band or channel of operation in order to maximize spectrum utilization composite equipment: any combined equipment made of two or more individual products or functions NOTE: The individual products or functions in composite equipment might be subject to different technical standards. conducted measurements: measurements that are made using a direct connection to the equipment under test dedicated antenna: removable antenna supplied and tested with the radio equipment, designed as an indispensable part of the equipment duly authorized healthcare professional: physician or other individual authorized by law to provide healthcare services using prescription medical devices duty cycle: ratio, expressed as a percentage, of the maximum transmitter "on" time monitored over one hour, relative to a one hour period NOTE: See clause 4.2.1.7. effective isotropically radiated power (e.i.r.p.): product of the power supplied to the antenna and the antenna gain in a given direction relative to an isotropic antenna NOTE: See clause 4.2.1.3. effective radiated power: power radiated within the emission bandwidth of the EUT in the direction of the maximum level under specified conditions of measurements in the presence of modulation or without modulation as appropriate emission bandwidth: measured as the width of the signal between the points on either side of centre frequency that are 20 dB down relative to the maximum level of the modulated signal frequency administration commands: commands, exclusively intended for testing purposes, which place the equipment under test in a specific frequency configuration, such as a channel or sub-set of channels frequency error: difference between the nominal frequency as measured on the equipment under test and under normal test conditions and the frequency under extreme conditions SIST EN 303 203 V2.1.1:2016

ETSI ETSI EN 303 203 V2.1.1 (2015-11) 10 frequency range: range of operating frequencies over which the equipment can be adjusted NOTE: See also clause 4.2.1.1.1. frequency stability under low voltage condition: ability of the equipment to remain on the nominal operating frequency when the battery voltage falls below the lower extreme voltage level NOTE: See also clause 4.2.1.6.1. healthcare facility: hospital or other establishment where medical care is provided by authorized healthcare professionals
healthcare facility mode: operational regime by which MBANS equipment is intended to be operated exclusively within healthcare facilities home mode: operational regime by which MBANS equipment is intended to be operated exclusively within patient residences integral antenna: permanent fixed antenna, which may be built-in, designed as an indispensable part of the equipment LBT threshold power level: ambient signal power level above which the monitoring system selects spectrum for MBANS transmissions according to the next available channel Least Interfered Channel (LIC): channel, among the available channels, that has the lowest potential for causing disturbance to or receiving disturbance from other users of the band Listen Before Talk (LBT): combination of the listen mode followed by the talk mode listen mode: action taken by an interrogator to detect an unoccupied sub-band or channel medical actuator: medical device responsible for performing an action on the human body for diagnostic and/or therapeutic purposes (e.g. an infusion pump) MBANS hub: medical device that selects the frequency of operation, gives instructions to participating devices of the MBANS, and controls system operation Medical Body Area Network System (MBANS): low power radio system used for the indoor transmission of non-voice data to and from medical devices for the purposes of monitoring, diagnosing and treating patients as prescribed by duly authorized healthcare professionals NOTE: A MBANS consists of one or more on-body wireless medical sensor devices and/or medical actuator devices that can communicate with a monitoring device placed on/around the human body. Such monitoring devices, in their role of MBANS hub, display and process physiological parameters from MBANS devices and may also forward them (e.g. to a central nurse station) by using wired or wireless technologies other than MBANSs. MBANS hubs control MBANS devices for the purpose of providing monitoring, diagnosis and treatment of patients. Implantable devices are not part of MBANSs. medical device: any instrument, apparatus, appliance, material or other article, falling under the Medical Device Directive (Directive 93/42/EEC [i.5]), whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the: • diagnosis, prevention, monitoring, treatment or alleviation of disease or injury; • investigation, replacement or modification of the anatomy or of a physiological process; • control of conception. medical sensor: medical device responsible for the collection of physiological parameters for diagnostic and/or therapeutic purposes monitoring system: circuitry that assures conformity with the spectrum access protocol requirements based on Listen Before Talk, Adaptive Frequency Agility and selection of the Least Interfered Channel for operation (LIC) or the unoccupied sub-band or channel out-of-band emissions: emissions on a frequency or frequencies immediately outside the necessary emission bandwidth, which result from the modulation process, but excluding emissions in the spurious domain SIST EN 303 203 V2.1.1:2016

ETSI ETSI EN 303 203 V2.1.1 (2015-11) 11 Power Spectral Density (PSD): amount of the total power inside the measuring receiver bandwidth expressed in dBm/Hz provider: manufacturer, or his authorized repr
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