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HARMONISED EUROPEAN STANDARD
ElectroMagnetic Compatibility (EMC)
standard for radio equipment and services;
Part 29: Specific conditions for Medical Data
Service Devices (MEDS) operating in the
401 MHz to 402 MHz and 405 MHz to 406 MHz bands;
Harmonised Standard covering the essential requirements
of article 3.1(b) of Directive 2014/53/EU
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2 ETSI EN 301 489-29 V2.2.1 (2019-04)
Reference
REN/ERM-EMC-375
Keywords
EMC, harmonised standard, radio, regulation,
short range
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3 ETSI EN 301 489-29 V2.2.1 (2019-04)
Contents
Intellectual Property Rights . 5
Foreword . 5
Modal verbs terminology . 5
1 Scope . 6
2 References . 6
2.1 Normative references . 6
2.2 Informative references . 7
3 Definitions and abbreviations . 7
3.1 Definitions . 7
3.2 Abbreviations . 8
4 Test conditions . 9
4.1 General . 9
4.2 Arrangements for test signals . 9
4.2.0 General . 9
4.2.1 Arrangements for test signals at the input of transmitters . 9
4.2.2 Arrangements for test signals at the RF output of transmitters . 9
4.2.2.0 General . 9
4.2.2.1 ULP- AMI and ULP-BWD transmitters . 10
4.2.2.2 ULP-AMI-P, ULP-AMD and ULP-AMD-P transmitters . 10
4.2.3 Arrangements for test signals at the RF input of receivers . 10
4.2.4 Arrangements for test signals at the output of receivers . 10
4.2.5 Arrangements for testing transmitter and receiver together (as a system: ULP-AMI together with an
associated ULP-AMI-P) . 10
4.3 RF exclusion band of radio equipment . 10
4.3.1 General . 10
4.3.2 Exclusion bands for receivers . 11
4.3.3 Exclusion band for transmitters . 11
4.4 Narrow band responses of receivers or receivers which are part of transceivers . 11
4.5 Normal test modulation . 11
5 Performance assessment . 12
5.1 General . 12
5.2 Equipment which can provide a continuous communication link . 12
5.3 Equipment which does not provide a continuous communication link . 12
5.4 Ancillary equipment . 12
5.5 Equipment classification . 12
6 Performance criteria . 13
6.1 Class of ULP-AMI, ULP-AMI-P, ULP-BWD, ULP-AMD and ULP-AMD-P devices covered by the
present document . 13
6.2 General performance criteria . 13
6.3 Performance criteria and table . 13
6.4 Performance criteria for continuous phenomena applied to transmitters . 15
6.5 Performance criteria for transient phenomena applied to transmitters . 15
6.6 Performance criteria for continuous phenomena applied to receivers . 15
6.7 Performance criteria for transient phenomena applied to receivers . 15
7 Applicability overview . 16
7.1 EMC emission . 16
7.1.1 General . 16
7.1.2 Special conditions . 16
7.2 Immunity . 16
7.2.1 General . 16
7.2.2 Special conditions . 17
ETSI
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4 ETSI EN 301 489-29 V2.2.1 (2019-04)
Annex A (informative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 20
Annex B (informative): ULP-AMI, ULP-AMD, ULP-BWD, ULP-AMD-P and ULP-AMI-P
devices intended for operation in the frequency range 401 MHz to
402 MHz and 405 MHz to 406 MHz . 22
Annex C (normative): Test fixture for Implanted (ULP-AMI) and Body Worn Devices
(ULP-BWD) . 23
C.1 Equipment in close proximity to the human body but external to it and devices intended to be
implanted in the body . 23
C.2 Human torso simulator for ULP-BWD and ULP-AMI . 23
Annex D (informative): Change history . 25
History . 26
ETSI
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5 ETSI EN 301 489-29 V2.2.1 (2019-04)
Intellectual Property Rights
Essential patents
IPRs essential or potentially essential to normative deliverables 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 (https://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.
Trademarks
The present document may include trademarks and/or tradenames which are asserted and/or registered by their owners.
ETSI claims no ownership of these except for any which are indicated as being the property of ETSI, and conveys no
right to use or reproduce any trademark and/or tradename. Mention of those trademarks in the present document does
not constitute an endorsement by ETSI of products, services or organizations associated with those trademarks.
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 under the Commission's standardisation request C(2015) 5376 final [i.7] to
provide one voluntary 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 and repealing
Directive 1999/5/EC [i.1].
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 is part 29 of a multi-part deliverable. Full details of the entire series can be found in part 1 [1].
National transposition dates
Date of adoption of this EN: 20 June 2017
Date of latest announcement of this EN (doa): 31 July 2019
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 January 2020
Date of withdrawal of any conflicting National Standard (dow): 31 January 2021
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.
ETSI
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6 ETSI EN 301 489-29 V2.2.1 (2019-04)
1 Scope
The present document together with ETSI EN 301 489-1 [1], covers the assessment of all radio transceivers associated
with Ultra Low Power Active Medical Implants (ULP-AMIs), Ultra Low Power Active Medical Devices (ULP-AMDs),
Ultra Low Power Body Worn Devices (ULP-BWDs) and associated Ultra Low Power Active Medical Implant
Peripherals (ULP-AMI-Ps), Ultra Low Power Active Medical Device Peripherals (ULP-AMD-Ps) in respect of
ElectroMagnetic Compatibility (EMC).
The radio link may be part of life supporting or non-life supporting equipment and can be classified independently of
the classification of the medical portion of the device.
The present document covers the EMC requirements for the radio functions of ultra low power implanted, body worn
and associated ultra low power peripheral devices.
Technical specifications related to the antenna port and emissions from the enclosure port of these radio system devices
are not included in the present document. Such technical specifications are found in the relevant product standards for
the effective use of the radio spectrum.
The present document applies to ULP-AMI, ULP-AMD, ULP-BWD, ULP-AMD-P and ULP-AMI-P devices with RF
power levels ranging up to 25 µW ERP and intended for operation in the frequency range 401 MHz to 402 MHz and
405 MHz to 406 MHz in accordance with the provisions of annex 12, band b) and band c), to
CEPT/ERC/REC 70-03 [i.3]. Definitions of such ULP-AMI, ULP-AMD, ULP-BWD, ULP-AMD-P and ULP-AMI-P
radio devices are found in the following functional radio standard:
• ETSI EN 302 537 [2]: "Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency
range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Harmonised Standard covering the essential
requirements of article 3.2 of the Directive 2014/53/EU [i.1]".
In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present
document and ETSI EN 301 489-1 [1], the provisions of the present document take precedence.
The environmental classification and the emission and immunity requirements used in the present document are as
stated in the ETSI EN 301 489-1 [1], except for any special conditions included in the present document.
The present document, together with ETSI EN 301 489-1 [1], are aimed to cover requirements to demonstrate an
adequate level of electromagnetic compatibility.
2 References
2.1 Normative references
References are specific, identified by date of publication and/or edition number or version number. Only the cited
version applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
https://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] ETSI EN 301 489-1 (V2.2.0) (03-2017): "ElectroMagnetic Compatibility (EMC) standard for
radio equipment and services; Part 1: Common technical requirements; Harmonised Standard
covering the essential requirements of article 3.1(b) of Directive 2014/53/EU and the essential
requirements of article 6 of Directive 2014/30/EU".
NOTE: Available at: http://www.etsi.org/deliver/etsi_en/301400_301499/30148901/02.02.00_20/.
ETSI
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7 ETSI EN 301 489-29 V2.2.1 (2019-04)
[2] ETSI EN 302 537 (V2.1.1) (10-2016): "Ultra Low Power Medical Data Service (MEDS) Systems
operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Harmonised
Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU".
[3] CENELEC EN 61000-4-5 (2006): "Electromagnetic compatibility (EMC) - Part 4-5: Testing and
measurement techniques - Surge immunity test".
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] 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.2] Void.
[i.3] CEPT/ERC/Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.4] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
[i.5] Camelia Gabriel: "Compilation of the dielectric properties of body tissues at RF and Microwave
Frequencies", (Physics Department, Kings College, London WC2R 2LS, UK).
[i.6] ETSI EN 301 489 (all parts): "Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services".
[i.7] Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation request
to the European Committee for Electrotechnical Standardisation and to the European
Telecommunications Standards Institute as regards radio equipment in support of
Directive 2014/53/EU of the European Parliament and of the Council.
3 Definitions and abbreviations
3.1 Definitions
For the purposes of the present document, the terms and definitions given in ETSI EN 301 489-1 [1], ETSI
EN 302 537 [2], Directive 2014/53/EU [i.1] and the following apply:
ancillary equipment: See definition in ETSI EN 301 489-1 [1].
environmental profile: range of environmental conditions under which equipment within the scope of each part the
multi-part deliverable ETSI EN 301 489 [i.6] is required to comply with the provisions of ETSI EN 301 489-1 [1]
life supporting equipment: equipment whose continued normal operation is required in order to sustain life
Medical Data Service (MEDS): service that uses a system specifically for the purpose of providing non-voice digital
communications between active medical implants and/or body worn devices and other devices external to the human
body engaged in transferring non-time critical individual patient related physiological information
Medical Data Service (MEDS) communication session: collection of transmissions that may or may not be
continuous, between co-operating ULP-AMI, ULP-AMI-P, ULP-BWD, ULP-AMD and ULP-AMD-P
ETSI
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8 ETSI EN 301 489-29 V2.2.1 (2019-04)
Medical Data Service (MEDS) System: collection of medical devices having RF transmitting capability, that are
associated with a specific patient that have the ability to communicate with each other using frequencies in the
401 MHz to 402 MHz and/or 405 MHz to 406 MHz bands
Medical Data Service (MEDS) System Communication Channel: any continuous segment of spectrum that is equal
to the emission bandwidth of the device with the largest bandwidth that is to participate in a MEDS session
NOTE: As stated in CEPT/ERC/REC 70-03 [i.3], annex 12 Bands a1) and a2), it is permitted to aggregate 25 kHz
segments up to a maximum of 100 kHz for each channel bandwidth.
Medical Data Service (MEDS) System Communication Link (MEDSCL): collection of transmissions that may or
may not be continuous, between MEDS system devices including at least one active medical implant or body worn
device together with other devices external to the body engaged in transferring non-time critical patient related
physiological information collected by a single MEDS system
Medical Data Service (MEDS) system device: any ultra low power medical device transmitting in the 401 MHz to
402 MHz and/or 405 MHz to 406 MHz band
NOTE: Only two types of MEDS system devices are permitted under the present document:
Frequency agile devices that are designed to access a minimum of 18 channels evenly distributed
across the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands with a minimum of 9 channels
defined for each 1 MHz segment (i.e. 401 MHz to 402 MHz and 405 MHz to 406 MHz).
Devices capable of operation only on a single channel using low duty cycle and low power for
spectrum access in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands.
Ultra Low Power Active Medical Device (ULP-AMD): radio part of a medical device that is also regulated under
Council Directive 93/42/EEC [i.4]
Ultra Low Power Active Medical Device Peripheral (ULP-AMD-P): radio part of medical equipment outside the
human body that communicates with an ULP-AMD, ULP-BWD or other ULP-AMD-P that is part of a MEDS
communication system
Ultra Low Power Active Medical Implant (ULP-AMI): radio part of an AIMD
Ultra Low Power Active Medical Implant Peripheral (ULP-AMI-P) device: radio part of medical equipment
outside the human body that communicates with an ULP-AMI to establish a medical implant communications link
Ultra Low Power Body Worn Device (ULP-BWD): radio part of a medical device, such as a physiological parameter
sensor or handheld device, that is intended to operate in very close proximity to the human body, including touching the
body, which has its radio antenna external to the body
3.2 Abbreviations
For the purposes of the present document, the abbreviations given in ETSI EN 301 489-1 [1], ETSI EN 302 537 [2],
Directive 2014/53/EU [i.1] and the following apply:
AC Alternating Current
AIMD Active Implantable Medical Devices
AMI Active Medical Implant
BWD Body Worn Devices
DC Direct Current
EMC ElectroMagnetic Compatibility
ERP Effective Radiated Power
EUT Equipment Under Test
ISM Industrial, Scientific and Medical
MEDS Medical Data Service
MEDSCL Medical Data Service System Communications Link
R&TTE Radio and Telecommunications Terminal Equipment
RF Radio Frequency
ULP Ultra Low Power
ULP-AMD Ultra Low Power Active Medical Device
ULP-AMD-P Ultra Low Power Active Medical Device Peripheral
ETSI
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9 ETSI EN 301 489-29 V2.2.1 (2019-04)
ULP-AMI Ultra Low Power Active Medical Implant
ULP-AMI-P Ultra Low Power Active Medical Implant Peripheral device
ULP-BWD Ultra Low Power Body Worn Device
4 Test conditions
4.1 General
For the purposes of the present document, the test conditions of the ETSI EN 301 489-1 [1], clause 4, shall apply as
appropriate. Further product related test conditions for ULP-AMI, ULP-AMI-P, ULP-BWD, ULP-AMD and
ULP-AMD-P are specified in the present document.
For emission and immunity tests the normal test modulation, test arrangements, etc., as specified in the present
document, clauses 4.1 to 4.5 shall apply.
Whenever the Equipment Under Test (EUT) is provided with a detachable antenna, the EUT shall be tested with the
antenna fitted in a manner typical of normal intended use, unless otherwise specified. If the EUT can be used with
several types of antenna the test shall be repeated for each type of antenna.
ULP-AMI devices (active medical implants) and ULP-BWD (body worn devices) are designed to be implanted within
or worn in very close proximity to a human body. Implant radio systems are isolated from disturbances by the
surrounding body tissue and body worn devices are subject to field distortions due to the proximity of the body. In order
to adequately assess the EMC characteristics of ULP-AMI and ULP-BWD devices , the use of a simulated man is
necessary. See annex C for additional details. The provisions of annex C are intended to provide an operational
environment that simulates, to the extent possible, actual usage conditions for these devices. It is necessary to use this
special fixture as described in annex B when making radiated emission measurements and immunity tests with radiated
RF fields.
4.2 Arrangements for test signals
4.2.0 General
The provisions of the ETSI EN 301 489-1 [1], clause 4.2 shall apply.
4.2.1 Arrangements for test signals at the input of transmitters
The provisions of the ETSI EN 301 489-1 [1], clause 4.2.1 shall apply with the following modifications:
• The transmitter shall be modulated with normal test modulation as specified for that type of equipment
(clause 4.5). Where transmitters do not have a modulation input port, the internal equipment modulation shall
be used.
4.2.2 Arrangements for test signals at the RF output of transmitters
4.2.2.0 General
The provisions of the ETSI EN 301 489-1 [1], clause 4.2.2 shall apply with the following modification:
• The manufacturer may provide a suitable companion receiver or other equipment that can be used to set up a
communications link and/or to receive messages.
ETSI
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10 ETSI EN 301 489-29 V2.2.1 (2019-04)
4.2.2.1 ULP- AMI and ULP-BWD transmitters
For ULP-AMI and ULP-BWD transmitters the test fixture described in annex C shall be used:
• The manufacturer shall provide a suitable receiver or other equipment that can be used to monitor the medical
device communications link.
4.2.2.2 ULP-AMI-P, ULP-AMD and ULP-AMD-P transmitters
The provisions of ETSI EN 301 489-1 [1], clause 4.2.2 shall apply with the following modifications:
• ULP-AMI-P, ULP-AMD and ULP-AMD-P devices are designed to be used external to a human body;
• the manufacturer shall provide a suitable receiver or other equipment that can be used to monitor the medical
system communications link.
4.2.3 Arrangements for test signals at the RF input of receivers
The provisions of ETSI EN 301 489-1 [1], clause 4.2.3 shall apply with the following modifications:
• the wanted RF input signal, coupled to the receiver, shall be modulated with normal test modulation as
specified for that type of equipment (clause 4.5);
• the level of the wanted RF input signal shall be 20 dB above the threshold sensitivity level of the receiver, but
in all cases it shall be below the overload characteristics of the receiver;
• the manufacturer shall provide a suitable transmitter that can be used to set up the medical implant
communications link.
4.2.4 Arrangements for test signals at the output of receivers
The provisions of ETSI EN 301 489-1 [1], clause 4.2.4 shall apply with the foll
...