SIST EN 301 489-29 V2.2.1:2019

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

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
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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

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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.
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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/.
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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
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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
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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.
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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 following modification, if appropriate:
• if direct access to the receiver output of the devices covered by the present document is not possible, then the
manufacturer shall provide the method by which the receiver's functionality can be monitored during the
immunity tests.
4.2.5 Arrangements for testing transmitter and receiver together
(as a system: ULP-AMI together with an associated ULP-AMI-P)
The provisions of ETSI EN 301 489-1 [1], clause 4.2.5 shall apply with the following modification:
• the transmitter and the receiver of each device intended to operate in a MEDS system may be tested together,
if appropriate and agreed to by the manufacturer and the test laboratory.
In this case all EUTs shall be located in their respective test environment and exposed simultaneously to the EMC
phenomena.
4.3 RF exclusion band of radio equipment
4.3.1 General
The emission measurement and immunity test exclusions are referred to as "exclusion bands" and are defined in the
clauses 4.3.2 and 4.3.3.
The frequencies on which the EUT(s) is(are) intended to operate, shall be excluded from conducted and radiated RF
immunity tests.
The frequencies on which the transmitter part of the EUT(s) is(are) intended to operate shall be excluded from emission
measurements when performed in transmit mode of operation.
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11 ETSI EN 301 489-29 V2.2.1 (2019-04)
During emission measurements, a frequency exclusion band does not apply for the receiver part of the equipment
covered by the present document.
4.3.2 Exclusion bands for receivers
The exclusion band for receivers (including receivers that are part of transceivers) is determined as follows:
• For receivers capable of operating on only one single frequency the lower frequency of the exclusion band is
the lower frequency of the used frequency channel minus the extension value given in table 1, and the upper
frequency of the exclusion band is the upper frequency of the used frequency channel plus the extension value
given in table 1. The calculated extension value shall be based on the operating frequency.
• For receivers capable of operating on 9 or more channels within the frequency band specified in table 1 and
not having an alignment range, the lower frequency of the exclusion band is the lower frequency of the used
frequency channel minus the extension value given in table 1, and the upper frequency of the exclusion band is
the upper frequency of the used frequency channel plus the extension value given in table 1. The calculated
extension value shall be based on the operating frequency.
• For wide band receivers, i.e. receivers operating in a non-channelized arrangement, the lower frequency of the
exclusion band is the lower is the lower frequency of the intended operating band minus the extension value
given in table 1 and the upper frequency of the exclusion band is the upper frequency of the intended operating
band plus the extension value given in table 1, or the total exclusion band is twice the intended operating
frequency band of the receiver centred around the centre frequency of the intended operating band, whichever
is the greater.
Table 1: Exclusion bands for the receiver part of MEDS Devices
Receiver operating frequency f Receiver exclusion bands
o
401 MHz to 402 MHz
f ± 10 MHz
o
405 MHz to 406 MHz
f ± 10 MHz
o
4.3.3 Exclusion band for transmitters
For transmitters operating, or intended to operate, in a channelized arrangement in the 401 MHz to 402 MHz and
405 MHz to 406 MHz frequency band, the exclusion band is nine times the maximum occupied bandwidth allowed for
that service, centred around the operating frequency. For the 401 MHz to 402 MHz and 405 MHz to 406 MHz
frequency bands, the maximum occupied bandwidth is 100 kHz. The actual occupied bandwidth is determined using the
procedures in ETSI EN 302 537 [2] for measuring emission bandwidth.
In case the receiver and transmitter are tested together as a system (see clause 4.2.5) the exclusion band defined for
receivers or the exclusion band defined for transmitters shall be used, whichever is greater.
4.4 Narrow band responses of receivers or receivers which are
part of transceivers
The provision of ETSI EN 301 489-1 [1], clause 4.4 shall apply.
4.5 Normal test modulation
The RF carrier shall be modulated with a test signal that produces specific selective messages or commands as stated by
the manufacturer, representing a practical selection of usable selective messages/commands. The manufacturer shall
declare the format of the modulation signal and any error detection and correction involved. Where transmitters do not
have a modulation input port, the internal equipment modulation is used.
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12 ETSI EN 301 489-29 V2.2.1 (2019-04)
5 Performance assessment
5.1 General
The provision of ETSI EN 301 489-1 [1], clause 5.1 shall apply.
The manufacturer shall at the time of submission of the device(s) for test, supply the necessary general information as
requested in ETSI EN 301 489-1 [1], clause 5.1. Additionally he shall supply the following product-related information:
• the class of the device selected by the manufacturer according to table 2 (see clause 6.1).
The performance assessment is dependent on whether the type of device is a ULP-AMI or a ULP-AMI-P.
For both types of devices the performance assessment is based on:
• the maintenance of function(s);
• the way an eventual loss of function(s) can be recovered;
• the unintentional behaviour of the EUT.
For both types of devices it shall be possible to assess the performance by monitoring the intended functions before,
during and after the tests.
5.2 Equipment which can provide a continuous communication
link
The provisions of ETSI EN 301 489-1 [1], clause 5.2 shall apply.
5.3 Equipment which does not provide a continuous
communication link
The provisions of ETSI EN 301 489-1 [1], clause 5.3 shall apply.
5.4 Ancillary equipment
The provision of ETSI EN 301 489-1 [1], clause 5.4 shall apply with the following modification:
• Emissions levels for ancillary equipment shall be measured according to the requirements for the specific
device.
Immunity levels for ancillary equipment that is specifically used with the EUT shall be tested with it connected to the
EUT in which case compliance shall be demonstrated to the appropriate clauses of the present document.
5.5 Equipment classification
The provisions of ETSI EN 301 489-1 [1], clause 5.5 shall apply with the following modifications:
• For the purpose of EMC performance assessment in the present document, the radio device/equipment and/or
associated ancillary device/equipment shall be classified into one of the following types:
- 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.
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13 ETSI EN 301 489-29 V2.2.1 (2019-04)
- ULP-AMD: Ultra Low Power Active Medical Device.
- ULP-AMD-P: Ultra Low Power Active Medical Device Peripheral.
• Life supporting devices shall meet the criteria specified for this type of device.
• Radio equipment declared as capable of being powered for intended use by the main battery of a vehicle shall
additionally be considered as mobile equipment.
6 Performance criteria
6.1 Class of ULP-AMI, ULP-AMI-P, ULP-BWD, ULP-AMD and
ULP-AMD-P devices covered by the present document
The radio systems of a product family of Active Implantable Medical Devices (AIMD), Active Medical Devices, Body
Worn Devices (BWD) and/or their associated peripheral devices forming part of or in total a Medical Data Service
operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz are classified in table 2. This classification is based
upon the impact on persons and/or goods in case the equipment does not operate at or above the specified minimum
performance level under EMC stress. The manufacturer of the above device(s) shall declare the classification of his
device(s). The test report shall note the classification of the device based on the manufacturers' declaration in table 2.
Table 2
Class of EUT Risk assessment of receiver performance
Highly reliable communication media; e.g. serving human life inherent systems (may
result in a physical risk to a person).
Medium reliable communication media; e.g. causing inconvenience to persons, which
cannot simply be overcome by other means.
Standard reliable communication media; e.g. inconvenience to persons, which can
simply be overcome by other means (e.g. manual).

6.2 General performance criteria
The performance criteria for the different classes of ULP-AMI/ULP-AMI-P/ULP-BWD ULP-AMD and ULP-AMD-P
devices (see table 2) in combination with the different equipment types during and after immunity test are specified in
this clause:
• performance criteria A for immunity tests with phenomena of a continuous nature;
• performance criteria B for immunity tests with phenomena of a transient nature;
• performance criteria for immunity tests with power interruptions exceeding a specified time are stated in
clause 7.2.2, table 4.
The device shall meet the performance criteria as specified in the following clauses, for the appropriate class of devices.
6.3 Performance criteria and table
For all device classes and types of EUTs it shall be possible to assess the performance by monitoring the intended
functions before, during and after the tests:
• the device under test can be assessed for performance by comparing, on an equal to or lower than basis, the
measured bit error rate with the bit error rate performance as specified by the manufacturer; or
• for devices under test that cannot be assessed using the above methods for assessment, the manufacturer shall
specify the assessment method to be used.
ETSI
14 ETSI EN 301 489-29 V2.2.1 (2019-04)
Under the test conditions specified in the present document the device and/or system under test shall be able to provide
the intended clinical benefit as specified by the manufacturer and remain safe for the user. The tested device may
exhibit a degradation of performance (deviation from manufacturer's specifications) as detailed in table 3.
Table 3
Class 1, All devices covered by the present document
Criteria During test After test
Operate as intended Operate as intended
No loss of function The communication link shall be maintained
A No unintentional responses No loss of function
No degradation of performance
No loss of stored data or user programmable functions
May be loss of function (one or more) Operate as intended
No unintentional responses
The communication link shall have been maintained
B No loss of function(s)
No degradation of performance
No loss of stored data or user programmable functions
Class 2, All devices covered by the present document
Criteria During test After test
Operate as intended Operate as intended
No loss of function below The communication link shall be maintained or recover
A manufacturers specification No loss of function below manufacturers specifications
No unintentional responses No degradation of performance
No loss of stored data or user programmable functions
May be loss of function (one or more) Operate as intended
No unintentional responses The communication link shall be maintained or recover
B No loss of function below manufacturers specifications
No degradation of performance
No loss of stored data or user programmable functions
Class 3, All devices covered by the present document
Criteria During test After test
May be loss of function (one or more) Operate as specified by the manufacturer, the communication
No unintentional responses link may be lost, but shall be recoverable by user
A and B No degradation of performance
Lost functions shall be self-recoverable or recoverable as
specified by the manufacturer
The following degradations or failures are not allowed during any phase of testing of devices covered by the present
document:
• component failures;
• changes in programmable parameters;
• reset to factory defaults (manufacturer's presets);
• change of intended operating mode;
• false alarms;
• cessation of any intended operation, even if accompanied by an alarm;
• initiation of any unintended operation, including unintended or uncontrolled motion, even if accompanied by
an alarm;
• error of a displayed numerical value sufficiently large to affect diagnosis or treatment;
• failure of automatic diagnosis or treatment devices and/or systems to diagnose or treat, even if accompanied by
an alarm;
• artefact or distortion in an image in which the artefact is indistinguishable from physiologically-produced
signals or the distortion interferes with interpretation of physiologically-produced signals;
ETSI
15 ETSI EN 301 489-29 V2.2.1 (2019-04)
• noise on a waveform in which the noise is indistinguishable from physiologically-produced signals or the
noise interferes with interpretation of physiologically-produced signals.
6.4 Performance criteria for continuous phenomena applied to
transmitters
For transmitters, the performance criteria A of the applicable class as given in clause 6.3 shall apply.
For the transmitter part of devices which require a communication link to be maintained during the test, it shall be
verified that the link is maintained during each individual exposure in the test sequence, by appropriate means supplied
by the manufacturer.
The test shall be repeated with the EUT in standby mode to ensure that no unintended transmission occurs as a result of
transmitter operation.
6.5 Performance criteria for transient phenomena applied to
transmitters
For transmitters, the performance criteria B of the applicable class as given in clause 6.3 shall apply, except for power
interruptions exceeding a certain time, the performance criteria deviations are specified in clause 7.2.2.
For the transmitter part of devices which require a communication link to be maintained during the test, it shall be
verified that the link is maintained during each individual exposure in the test sequence, by appropriate means supplied
by the manufacturer.
The test shall be repeated with the EUT in standby mode to ensure that no unintended transmission occurs as a result of
transmitter operation.
6.6 Performance criteria for continuous phenomena applied to
receivers
For the receiver part the performance criteria A of the applicable class as given in clause 6.3 shall apply.
For the receiver part of devices which require a communication link to be maintained during the test, it shall be verified
that the communicatio
...

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.(8ElectroMagnetic 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/EU35.240.80Uporabniške rešitve IT v zdravstveni tehnikiIT applications in health care technology33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.99Druga oprema za radijske komunikacijeOther equipment for radiocommunicationsICS:Ta slovenski standard je istoveten z:ETSI EN 301 489-29 V2.2.1 (2019-04)SIST EN 301 489-29 V2.2.1:2019en01-junij-2019SIST EN 301 489-29 V2.2.1:2019SLOVENSKI
STANDARD
HARMONISED EUROPEAN STANDARD SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)2
Reference REN/ERM-EMC-375 Keywords EMC, harmonised standard, radio, regulation, short range ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
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DECTTM, PLUGTESTSTM, UMTSTM and the ETSI logo are trademarks of ETSI registered for the benefit of its Members. 3GPPTM and LTETM are trademarks of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. oneM2M™ logo is a trademark of ETSI registered for the benefit of its Members and of the oneM2M Partners. GSM® and the GSM logo are trademarks registered and owned by the GSM Association. SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)3 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 SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)4 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 ETSI EN 301 489-29 V2.2.1 (2019-04)5 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. SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)6 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/. SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)7 [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 SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)8 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 SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)9 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. SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)10 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 following modification, if appropriate: • if direct access to the receiver output of the devices covered by the present document is not possible, then the manufacturer shall provide the method by which the receiver's functionality can be monitored during the immunity tests. 4.2.5 Arrangements for testing transmitter and receiver together (as a system: ULP-AMI together with an associated ULP-AMI-P) The provisions of ETSI EN 301 489-1 [1], clause 4.2.5 shall apply with the following modification: • the transmitter and the receiver of each device intended to operate in a MEDS system may be tested together, if appropriate and agreed to by the manufacturer and the test laboratory. In this case all EUTs shall be located in their respective test environment and exposed simultaneously to the EMC phenomena. 4.3 RF exclusion band of radio equipment 4.3.1 General The emission measurement and immunity test exclusions are referred to as "exclusion bands" and are defined in the clauses 4.3.2 and 4.3.3. The frequencies on which the EUT(s) is(are) intended to operate, shall be excluded from conducted and radiated RF immunity tests. The frequencies on which the transmitter part of the EUT(s) is(are) intended to operate shall be excluded from emission measurements when performed in transmit mode of operation. SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)11 During emission measurements, a frequency exclusion band does not apply for the receiver part of the equipment covered by the present document. 4.3.2 Exclusion bands for receivers The exclusion band for receivers (including receivers that are part of transceivers) is determined as follows: • For receivers capable of operating on only one single frequency the lower frequency of the exclusion band is the lower frequency of the used frequency channel minus the extension value given in table 1, and the upper frequency of the exclusion band is the upper frequency of the used frequency channel plus the extension value given in table 1. The calculated extension value shall be based on the operating frequency. • For receivers capable of operating on 9 or more channels within the frequency band specified in table 1 and not having an alignment range, the lower frequency of the exclusion band is the lower frequency of the used frequency channel minus the extension value given in table 1, and the upper frequency of the exclusion band is the upper frequency of the used frequency channel plus the extension value given in table 1. The calculated extension value shall be based on the operating frequency. • For wide band receivers, i.e. receivers operating in a non-channelized arrangement, the lower frequency of the exclusion band is the lower is the lower frequency of the intended operating band minus the extension value given in table 1 and the upper frequency of the exclusion band is the upper frequency of the intended operating band plus the extension value given in table 1, or the total exclusion band is twice the intended operating frequency band of the receiver centred around the centre frequency of the intended operating band, whichever is the greater. Table 1: Exclusion bands for the receiver part of MEDS Devices Receiver operating frequency fo Receiver exclusion bands 401 MHz to 402 MHz fo ± 10 MHz 405 MHz to 406 MHz fo ± 10 MHz
4.3.3 Exclusion band for transmitters For transmitters operating, or intended to operate, in a channelized arrangement in the 401 MHz to 402 MHz and 405 MHz to 406 MHz frequency band, the exclusion band is nine times the maximum occupied bandwidth allowed for that service, centred around the operating frequency. For the 401 MHz to 402 MHz and 405 MHz to 406 MHz frequency bands, the maximum occupied bandwidth is 100 kHz. The actual occupied bandwidth is determined using the procedures in ETSI EN 302 537 [2] for measuring emission bandwidth. In case the receiver and transmitter are tested together as a system (see clause 4.2.5) the exclusion band defined for receivers or the exclusion band defined for transmitters shall be used, whichever is greater. 4.4 Narrow band responses of receivers or receivers which are part of transceivers The provision of ETSI EN 301 489-1 [1], clause 4.4 shall apply. 4.5 Normal test modulation The RF carrier shall be modulated with a test signal that produces specific selective messages or commands as stated by the manufacturer, representing a practical selection of usable selective messages/commands. The manufacturer shall declare the format of the modulation signal and any error detection and correction involved. Where transmitters do not have a modulation input port, the internal equipment modulation is used. SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)12 5 Performance assessment 5.1 General The provision of ETSI EN 301 489-1 [1], clause 5.1 shall apply. The manufacturer shall at the time of submission of the device(s) for test, supply the necessary general information as requested in ETSI EN 301 489-1 [1], clause 5.1. Additionally he shall supply the following product-related information: • the class of the device selected by the manufacturer according to table 2 (see clause 6.1). The performance assessment is dependent on whether the type of device is a ULP-AMI or a ULP-AMI-P. For both types of devices the performance assessment is based on: • the maintenance of function(s); • the way an eventual loss of function(s) can be recovered; • the unintentional behaviour of the EUT. For both types of devices it shall be possible to assess the performance by monitoring the intended functions before, during and after the tests. 5.2 Equipment which can provide a continuous communication link The provisions of ETSI EN 301 489-1 [1], clause 5.2 shall apply. 5.3 Equipment which does not provide a continuous communication link The provisions of ETSI EN 301 489-1 [1], clause 5.3 shall apply. 5.4 Ancillary equipment The provision of ETSI EN 301 489-1 [1], clause 5.4 shall apply with the following modification: • Emissions levels for ancillary equipment shall be measured according to the requirements for the specific device. Immunity levels for ancillary equipment that is specifically used with the EUT shall be tested with it connected to the EUT in which case compliance shall be demonstrated to the appropriate clauses of the present document. 5.5 Equipment classification The provisions of ETSI EN 301 489-1 [1], clause 5.5 shall apply with the following modifications: • For the purpose of EMC performance assessment in the present document, the radio device/equipment and/or associated ancillary device/equipment shall be classified into one of the following types: - 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. SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)13 - ULP-AMD: Ultra Low Power Active Medical Device. - ULP-AMD-P: Ultra Low Power Active Medical Device Peripheral. • Life supporting devices shall meet the criteria specified for this type of device. • Radio equipment declared as capable of being powered for intended use by the main battery of a vehicle shall additionally be considered as mobile equipment. 6 Performance criteria 6.1 Class of ULP-AMI, ULP-AMI-P, ULP-BWD, ULP-AMD and ULP-AMD-P devices covered by the present document The radio systems of a product family of Active Implantable Medical Devices (AIMD), Active Medical Devices, Body Worn Devices (BWD) and/or their associated peripheral devices forming part of or in total a Medical Data Service operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz are classified in table 2. This classification is based upon the impact on persons and/or goods in case the equipment does not operate at or above the specified minimum performance level under EMC stress. The manufacturer of the above device(s) shall declare the classification of his device(s). The test report shall note the classification of the device based on the manufacturers' declaration in table 2. Table 2 Class of EUT Risk assessment of receiver performance 1 Highly reliable communication media; e.g. serving human life inherent systems (may result in a physical risk to a person). 2 Medium reliable communication media; e.g. causing inconvenience to persons, which cannot simply be overcome by other means. 3 Standard reliable communication media; e.g. inconvenience to persons, which can simply be overcome by other means (e.g. manual).
6.2 General performance criteria The performance criteria for the different classes of ULP-AMI/ULP-AMI-P/ULP-BWD ULP-AMD and ULP-AMD-P devices (see table 2) in combination with the different equipment types during and after immunity test are specified in this clause: • performance criteria A for immunity tests with phenomena of a continuous nature; • performance criteria B for immunity tests with phenomena of a transient nature; • performance criteria for immunity tests with power interruptions exceeding a specified time are stated in clause 7.2.2, table 4. The device shall meet the performance criteria as specified in the following clauses, for the appropriate class of devices. 6.3 Performance criteria and table For all device classes and types of EUTs it shall be possible to assess the performance by monitoring the intended functions before, during and after the tests: • the device under test can be assessed for performance by comparing, on an equal to or lower than basis, the measured bit error rate with the bit error rate performance as specified by the manufacturer; or • for devices under test that cannot be assessed using the above methods for assessment, the manufacturer shall specify the assessment method to be used. SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)14 Under the test conditions specified in the present document the device and/or system under test shall be able to provide the intended clinical benefit as specified by the manufacturer and remain safe for the user. The tested device may exhibit a degradation of performance (deviation from manufacturer's specifications) as detailed in table 3. Table 3 Class 1, All devices covered by the present document Criteria During test After test A Operate as intended No loss of function No unintentional responses Operate as intended The communication link shall be maintained No loss of function No degradation of performance No loss of stored data or user programmable functions B May be loss of function (one or more) No unintentional responses Operate as intended The communication link shall have been maintained No loss of function(s) No degradation of performance No loss of stored data or user programmable functions Class 2, All devices covered by the present document Criteria During test After test A Operate as intended No loss of function below manufacturers specification No unintentional responses Operate as intended The communication link shall be maintained or recover No loss of function below manufacturers specifications No degradation of performance No loss of stored data or user programmable functions B May be loss of function (one or more) No unintentional responses Operate as intended The communication link shall be maintained or recover No loss of function below manufacturers specifications No degradation of performance No loss of stored data or user programmable functions Class 3, All devices covered by the present document Criteria During test After test A and B May be loss of function (one or more) No unintentional responses Operate as specified by the manufacturer, the communication link may be lost, but shall be recoverable by user No degradation of performance Lost functions shall be self-recoverable or recoverable as specified by the manufacturer
The following degradations or failures are not allowed during any phase of testing of devices covered by the present document: • component failures; • changes in programmable parameters; • reset to factory defaults (manufacturer's presets); • change of intended operating mode; • false alarms; • cessation of any intended operation, even if accompanied by an alarm; • initiation of any unintended operation, including unintended or uncontrolled motion, even if accompanied by an alarm; • error of a displayed numerical value sufficiently large to affect diagnosis or treatment; • failure of automatic diagnosis or treatment devices and/or systems to diagnose or treat, even if accompanied by an alarm; • artefact or distortion in an image in which the artefact is indistinguishable from physiologically-produced signals or the distortion interferes with interpretation of physiologically-produced signals; SIST EN 301 489-29 V2.2.1:2019

ETSI ETSI EN 301 489-29 V2.2.1 (2019-04)15 • noise on a waveform in which the noise is indistinguishable from physiologically-produced signals or the noise interferes with interpretation of physiologically-produced signals. 6.4 Performance criteria for continuous phenomena applied to transmitters For transmitters, the performance criteria A of the applicable class as given in clause 6.3 shall apply. For the transmitter part of devices which require a communication link to be maintained during the test, it shall be verified that the link is maintained during each individual exposure in the test sequence, by appropriate means supplied by the manufacturer. The test shall be repeated with the EUT in standby mode to ensure that no unintended transmission occurs as a result of transmitter operation. 6.5 Performance criteria for transient phenomena applied to transmitters For transmitters, the performance criteria B of the applicable class as given in clause 6.3 shall apply, except for power interruptions exceeding a certain time, the performance criteria deviations are specified in clause 7.2.2. For the transmitter part of devices which require a communication link to be maintained during the test, it shall be verified that the link is maintained during each individual exposure in the test sequence, by appropriate means supplied by the manufacturer. The test shall be repeated with the EUT in standby mode to ensure that no unintended transmission occurs as a result of transmitter operation. 6.6 Performance criteria for continuous phenomena applied to receivers For the receiver part the performance criteria A of the applicable class as given in clause 6.3 shall apply. For the receiver part of devices which require a communication link to be maintained during the test, it shall be verified that the communication link is maintained during each individual exp
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