ETSI EN 302 510 V2.1.1 (2017-01)

ETSI EN 302 510 V2.1.1 (2017-01)






HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Ultra Low Power Active
Medical Membrane Implants (ULP-AMI-M) and
Peripherals (ULP-AMI-M-P)
operating in the frequency range 30 MHz to 37,5 MHz;
Harmonised Standard covering the essential requirements
of article 3.2 of the Directive 2014/53/EU

---------------------- Page: 1 ----------------------
2 ETSI EN 302 510 V2.1.1 (2017-01)



Reference
REN/ERM-TG30-308
Keywords
harmonised standard, radio, regulation

ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE

Tel.: +33 4 92 94 42 00  Fax: +33 4 93 65 47 16

Siret N° 348 623 562 00017 - NAF 742 C
Association à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88

Important notice
The present document can be downloaded from:
http://www.etsi.org/standards-search
The present document may be made available in electronic versions and/or in print. The content of any electronic and/or
print versions of the present document shall not be modified without the prior written authorization of ETSI. In case of any
existing or perceived difference in contents between such versions and/or in print, the only prevailing document is the
print of the Portable Document Format (PDF) version kept on a specific network drive within ETSI Secretariat.
Users of the present document should be aware that the document may be subject to revision or change of status.
Information on the current status of this and other ETSI documents is available at
https://portal.etsi.org/TB/ETSIDeliverableStatus.aspx
If you find errors in the present document, please send your comment to one of the following services:
https://portal.etsi.org/People/CommiteeSupportStaff.aspx
Copyright Notification
No part may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying
and microfilm except as authorized by written permission of ETSI.
The content of the PDF version shall not be modified without the written authorization of ETSI.
The copyright and the foregoing restriction extend to reproduction in all media.

© European Telecommunications Standards Institute 2017.
All rights reserved.

TM TM TM
DECT , PLUGTESTS , UMTS and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members.
TM
3GPP and LTE™ are Trade Marks of ETSI registered for the benefit of its Members and
of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI

---------------------- Page: 2 ----------------------
3 ETSI EN 302 510 V2.1.1 (2017-01)
Contents
Intellectual Property Rights . 6
Foreword . 6
Modal verbs terminology . 6
Introduction . 7
1 Scope . 8
2 References . 8
2.1 Normative references . 8
2.2 Informative references . 8
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 11
3.3 Abbreviations . 11
4 Technical requirements specifications . 11
4.1 Environmental profile . 11
4.2 Conformance requirements . 11
4.2.1 Transmitter requirements . 11
4.2.1.1 Effective Radiated Power . 11
4.2.1.1.1 Definition. 11
4.2.1.1.2 Limits . 11
4.2.1.1.3 Conformance . 12
4.2.1.2 Out of band emissions . 12
4.2.1.2.1 Definition. 12
4.2.1.2.2 Limits . 12
4.2.1.2.3 Conformance . 12
4.2.1.3 Unwanted emissions in the spurious domain of transmitters . 12
4.2.1.3.1 Definition. 12
4.2.1.3.2 Limits . 12
4.2.1.3.3 Conformance . 13
4.2.1.4 Duty Cycle . 13
4.2.1.4.1 Definition. 13
4.2.1.4.2 Limits . 13
4.2.1.4.3 Conformance . 13
4.2.2 Receiver requirements . 13
4.2.2.1 Receiver Blocking or Desensitization . 13
4.2.2.1.0 Receiver Classification . 13
4.2.2.1.1 Definition. 14
4.2.2.1.2 Limits . 14
4.2.2.1.3 Conformance . 14
4.2.2.2 Receiver Spurious radiation . 14
4.2.2.2.1 Definition. 14
4.2.2.2.2 Limits . 14
4.2.2.2.3 Conformance . 14
4.3 Mechanical and electrical design . 15
4.3.1 General . 15
4.3.2 Controls . 15
4.3.3 Transmitter shut-off facility . 15
5 Testing for compliance with technical requirements . 15
5.1 Environmental conditions for testing . 15
5.1.0 General provisions . 15
5.1.1 Presentation of equipment for testing purposes . 15
5.1.1.0 General provisions . 15
5.1.1.1 Choice of model for testing . 15
5.1.1.2 Testing of equipment with alternate power levels . 16
ETSI

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4 ETSI EN 302 510 V2.1.1 (2017-01)
5.1.1.3 Testing of equipment that does not have an external RF connector (integral antenna equipment) . 16
5.1.1.3.0 General Provision . 16
5.1.1.3.1 Equipment with an internal permanent or temporary antenna connector . 16
5.1.1.3.2 Equipment with a temporary antenna connector . 16
5.1.1.3.3 Equipment intended to be implanted in a human body . 16
5.1.2 Declaration by the applicant . 16
5.1.3 Auxiliary test equipment . 16
5.1.4 Test Conditions . 17
5.1.4.1 Normal and extreme test conditions . 17
5.1.4.2 Test power source . 17
5.1.4.2.0 General provisions . 17
5.1.4.2.1 External test power source . 17
5.1.4.2.2 Internal test power source . 17
5.1.4.3 Normal test conditions . 18
5.1.4.3.1 Normal temperature and humidity . 18
5.1.4.3.2 Normal test power source . 18
5.1.4.4 Extreme test conditions . 18
5.1.4.4.1 Extreme temperatures . 18
5.1.4.4.2 Extreme test source voltages . 20
5.1.4.5 Normal test signals and test modulation. 20
5.1.4.5.0 General provisions . 20
5.1.4.5.1 Normal modulation test signals for data . 20
5.1.4.6 Antennas . 21
5.1.4.6.0 General provisions . 21
5.1.4.6.1 Artificial antenna . 21
5.1.4.6.2 Artificial antenna for transmitters with 50 Ω impedance connector . 21
5.1.4.7 Test fixture for ULP-AMI-M-P . 21
5.1.4.8 Test fixture for ULP-AMI-M . 22
5.1.4.9 Test sites and general arrangements for radiated measurements . 22
5.1.4.10 Modes of operation of the transmitter . 22
5.1.4.11 Measuring receiver . 22
5.2 Interpretation of the measurement results . 23
5.3 Methods of measurement . 23
5.3.1 Maximum Effective Radiated Power . 23
5.3.2 Out of band emissions. 24
5.3.3 Unwanted Emissions in the spurious domain . 25
5.3.4 Duty Cycle . 26
5.3.5 Receiver Blocking or desensitization . 26
5.3.6 Receiver Spurious radiation . 26
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 28
Annex B (normative): Radiated Measurement . 29
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 29
B.1.1 Outdoor test site . 29
B.1.1.0 General remarks . 29
B.1.1.1 Standard position . 29
B.1.1.2 Equipment in close proximity to the human body but external to it . 30
B.1.1.3 Human torso simulator for ULP-AMI-M . 30
B.1.2 Test antenna . 31
B.1.3 Substitution antenna . 31
B.1.4 Optional additional indoor site . 32
B.2 Guidance on the use of radiation test sites . 33
B.2.0 General remarks . 33
B.2.1 Measuring distance . 33
B.2.2 Test antenna . 33
B.2.3 Substitution antenna . 33
B.2.4 Artificial antenna . 33
B.2.5 Auxiliary cables . 33
ETSI

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5 ETSI EN 302 510 V2.1.1 (2017-01)
B.3 Further optional alternative indoor test site using an anechoic chamber . 34
B.3.0 General remarks . 34
B.3.1 Example of the construction of a shielded anechoic chamber . 34
B.3.2 Influence of parasitic reflections in anechoic chambers . 34
B.3.3 Calibration of the shielded RF anechoic chamber . 35
Annex C (normative): Technical performance of the spectrum analyser . 37
Annex D (informative): Bibliography . 38
History . 39


ETSI

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6 ETSI EN 302 510 V2.1.1 (2017-01)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (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.
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.

National transposition dates
Date of adoption of this EN: 27 December 2016
Date of latest announcement of this EN (doa): 31 March 2017
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 30 September 2017
Date of withdrawal of any conflicting National Standard (dow): 30 September 2018

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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7 ETSI EN 302 510 V2.1.1 (2017-01)
Introduction
Membrane Implants and associated peripheral equipment are a new technology in the medical field that provides, on a
continuing non-invasive basis after the implant is inserted, patient related real time intravenous blood pressure
information to the attending physician. This information is used for purposes of diagnosing and treating certain heart
related disorders thereby reducing significantly the hospital readmission rate.
The present document is a specific product standard applicable to Ultra Low Power Active Medical Membrane Implants
and Peripherals operating in the frequency range 30 MHz to 37,5 MHz.
The frequency usage conditions for the band 30 MHz to 37,5 MHz are EU wide harmonised for the SRD category
"active medical implant devices" according to 2013/752/EU [i.10].
The present document is structured in the following way:
• Clauses 1 through 3 provide a general description on the types of equipment covered by the present document
and the definitions, symbols and abbreviations used.
• Clause 4 provides the technical requirements, specifications, limits and conformance relative to transmitter,
receiver, and spectrum access.
• Clauses 5.1 and 5.2 specify the conditions for testing of the equipment and interpretation of the measurement
results with the maximum measurement uncertainty values.
• Clause 5.3 specifies the required measurement methods. In particular clause 5.3.8 describes the monitoring
system performance specifications that have been chosen to minimize harmful interference to other equipment
or services and minimize the potential for disturbance to this equipment from ambient sources or other medical
device users in the band.
• Annex A (normative) provides the relationship between the present document and the essential requirements
of Directive 2014/53/EU [i.1].
• Annex B (normative) provides specifications concerning radiated measurements.
• Annex C (normative) provides technical performance of the spectrum analyser.
• Annex D (informative) bibliography; provides additional information.

ETSI

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8 ETSI EN 302 510 V2.1.1 (2017-01)
1 Scope
The present document applies to Ultra Low Power-Active Medical Membrane Implants and Membrane Implant
Peripherals as described in Directive 90/385/EEC [i.4], covering all active medical implants, that operate in a Medical
Implant Communications System in the frequency band 30 MHz to 37,5 MHz.
Table 1: Ultra Low Power Active Medical Membrane Implants and
Peripherals operating in the frequency band 30 MHz to 37,5 MHz
Ultra Low Power Active Medical Membrane Implants

and Peripherals service frequency bands
Transmitters - Ultra Low Power Active Medical
30 MHz to 37,5 MHz
Membrane Implants and peripherals
Receivers - Ultra Low Power Active Medical
30 MHz to 37,5 MHz
Membrane Implants and peripherals

The present document contains the technical requirements for characteristics of ULP-AMI-M and ULP-AMI-M-P radio
equipment which are aligned with annex 12 Sub-band (d) of CEPT/ERC Recommendation 70-03 [i.6].
The frequency usage conditions for the band 30 MHz to 37,5 MHz are EU wide harmonised for the SRD category
"active medical implant devices" according to 2013/752/EU [i.10] with the following usage restrictions:
• "This set of usage conditions is only available to ultra-low power medical membrane implants for blood
pressure measurements within the definition of active implantable medical devices in Directive 90/385/EEC."
The present document contains requirements to demonstrate that Ultra Low Power Active Medical Membrane Implants
and peripherals used in a medical membrane implant communications system "… shall be so constructed that it both
effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference" (article 3.2 of
the Directive 2014/53/EU [i.1]). It does not necessarily include all the characteristics, which may be required by a user,
nor does it necessarily represent the optimum performance achievable.
2 References
2.1 Normative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
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] CISPR 16-2-3 (2010): "Specification for radio disturbance and immunity measuring apparatus and
methods. Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance
measurements".
2.2 Informative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
ETSI

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9 ETSI EN 302 510 V2.1.1 (2017-01)
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
...

Draft ETSI EN 302 510 V2.0.1 (2016-09)






HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Ultra Low Power Active
Medical Membrane Implants (ULP-AMI-M) and
Peripherals (ULP-AMI-M-P)
operating in the frequency range 30 MHz to 37,5 MHz;
Harmonised Standard covering the essential requirements
of article 3.2 of the Directive 2014/53/EU

---------------------- Page: 1 ----------------------
2 Draft ETSI EN 302 510 V2.0.1 (2016-09)



Reference
REN/ERM-TG30-308
Keywords
harmonised standard, radio, regulation

ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE

Tel.: +33 4 92 94 42 00  Fax: +33 4 93 65 47 16

Siret N° 348 623 562 00017 - NAF 742 C
Association à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88

Important notice
The present document can be downloaded from:
http://www.etsi.org/standards-search
The present document may be made available in electronic versions and/or in print. The content of any electronic and/or
print versions of the present document shall not be modified without the prior written authorization of ETSI. In case of any
existing or perceived difference in contents between such versions and/or in print, the only prevailing document is the
print of the Portable Document Format (PDF) version kept on a specific network drive within ETSI Secretariat.
Users of the present document should be aware that the document may be subject to revision or change of status.
Information on the current status of this and other ETSI documents is available at
https://portal.etsi.org/TB/ETSIDeliverableStatus.aspx
If you find errors in the present document, please send your comment to one of the following services:
https://portal.etsi.org/People/CommiteeSupportStaff.aspx
Copyright Notification
No part may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying
and microfilm except as authorized by written permission of ETSI.
The content of the PDF version shall not be modified without the written authorization of ETSI.
The copyright and the foregoing restriction extend to reproduction in all media.

© European Telecommunications Standards Institute 2016.
All rights reserved.

TM TM TM
DECT , PLUGTESTS , UMTS and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members.
TM
3GPP and LTE™ are Trade Marks of ETSI registered for the benefit of its Members and
of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI

---------------------- Page: 2 ----------------------
3 Draft ETSI EN 302 510 V2.0.1 (2016-09)
Contents
Intellectual Property Rights . 6
Foreword . 6
Modal verbs terminology . 6
Introduction . 7
1 Scope . 8
2 References . 8
2.1 Normative references . 8
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 9
3.1 Definitions . 9
3.2 Symbols . 11
3.3 Abbreviations . 11
4 Technical requirements specifications . 11
4.1 Environmental profile . 11
4.2 Conformance requirements . 11
4.2.1 Transmitter requirements . 11
4.2.1.1 Effective Radiated Power . 11
4.2.1.1.1 Definition. 11
4.2.1.1.2 Limits . 12
4.2.1.1.3 Conformance . 12
4.2.1.2 Out of band dmissions . 12
4.2.1.2.1 Definition. 12
4.2.1.2.2 Limits . 12
4.2.1.2.3 Conformance . 12
4.2.1.3 Unwanted emissions in the spurious domain of transmitters . 12
4.2.1.3.1 Definition. 12
4.2.1.3.2 Limits . 12
4.2.1.3.3 Conformance . 13
4.2.1.4 Duty Cycle . 13
4.2.1.4.1 Definition. 13
4.2.1.4.2 Limits . 13
4.2.1.4.3 Conformance . 13
4.2.2 Receiver requirements . 13
4.2.2.1 Receiver Blocking or Desensitization . 13
4.2.2.1.0 Receiver Classification . 13
4.2.2.1.1 Definition. 14
4.2.2.1.2 Limits . 14
4.2.2.1.3 Conformance . 14
4.2.2.2 Receiver Spurious radiation . 14
4.2.2.2.1 Definition. 14
4.2.2.2.2 Limits . 15
4.2.2.2.3 Conformance . 15
4.3 Mechanical and electrical design . 15
4.3.1 General . 15
4.3.2 Controls . 15
4.3.3 Transmitter shut-off facility . 15
5 Testing for compliance with technical requirements . 15
5.1 Environmental conditions for testing . 15
5.1.0 General provisions . 15
5.1.1 Presentation of equipment for testing purposes . 16
5.1.1.0 General provisions . 16
5.1.1.1 Choice of model for testing . 16
5.1.1.2 Testing of equipment with alternate power levels . 16
ETSI

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4 Draft ETSI EN 302 510 V2.0.1 (2016-09)
5.1.1.3 Testing of equipment that does not have an external RF connector (integral antenna equipment) . 16
5.1.1.3.0 General Provision . 16
5.1.1.3.1 Equipment with an internal permanent or temporary antenna connector . 16
5.1.1.3.2 Equipment with a temporary antenna connector . 16
5.1.1.3.3 Equipment intended to be implanted in a human body . 17
5.1.2 Declaration by the applicant . 17
5.1.3 Auxiliary test equipment . 17
5.1.4 Test Conditions . 17
5.1.4.1 Normal and extreme test conditions . 17
5.1.4.2 Test power source . 17
5.1.4.2.0 General provisions . 17
5.1.4.2.1 External test power source . 17
5.1.4.2.2 Internal test power source . 18
5.1.4.3 Normal test conditions . 18
5.1.4.3.1 Normal temperature and humidity . 18
5.1.4.3.2 Normal test power source . 18
5.1.4.4 Extreme test conditions . 19
5.1.4.4.1 Extreme temperatures . 19
5.1.4.4.2 Extreme test source voltages . 20
5.1.4.5 Normal test signals and test modulation. 21
5.1.4.5.0 General provisions . 21
5.1.4.5.1 Normal modulation test signals for data . 21
5.1.4.6 Antennas . 21
5.1.4.6.0 General provisions . 21
5.1.4.6.1 Artificial antenna . 21
5.1.4.6.2 Artificial antenna for transmitters with 50 Ω impedance connector . 21
5.1.4.7 Test fixture for ULP-AMI-M-P . 22
5.1.4.8 Test fixture for ULP-AMI-M . 22
5.1.4.9 Test sites and general arrangements for radiated measurements . 23
5.1.4.10 Modes of operation of the transmitter . 23
5.1.4.11 Measuring receiver . 23
5.2 Interpretation of the measurement results . 23
5.3 Methods of measurement . 24
5.3.1 Maximum Effective Radiated Power . 24
5.3.2 Out of band emissions. 25
5.3.3 Unwanted Emissions in the spurious domain . 25
5.3.4 Duty Cycle . 26
5.3.5 Receiver Blocking or desensitization . 26
5.3.6 Receiver Spurious radiation . 27
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 28
Annex B (normative): Radiated Measurement . 29
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 29
B.1.1 Outdoor test site . 29
B.1.1.0 General remarks . 29
B.1.1.1 Standard position . 29
B.1.1.2 Equipment in close proximity to the human body but external to it . 30
B.1.1.3 Human torso simulator for ULP-AMI-M . 30
B.1.2 Test antenna . 31
B.1.3 Substitution antenna . 31
B.1.4 Optional additional indoor site . 32
B.2 Guidance on the use of radiation test sites . 33
B.2.0 General remarks . 33
B.2.1 Measuring distance . 33
B.2.2 Test antenna . 33
B.2.3 Substitution antenna . 33
B.2.4 Artificial antenna . 33
B.2.5 Auxiliary cables . 33
ETSI

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5 Draft ETSI EN 302 510 V2.0.1 (2016-09)
B.3 Further optional alternative indoor test site using an anechoic chamber . 34
B.3.0 General remarks . 34
B.3.1 Example of the construction of a shielded anechoic chamber . 34
B.3.2 Influence of parasitic reflections in anechoic chambers . 34
B.3.3 Calibration of the shielded RF anechoic chamber . 35
Annex C (normative): Technical performance of the spectrum analyser . 37
Annex D (informative): Bibliography . 38
History . 39


ETSI

---------------------- Page: 5 ----------------------
6 Draft ETSI EN 302 510 V2.0.1 (2016-09)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (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.
Foreword
This draft Harmonised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic
compatibility and Radio spectrum Matters (ERM), and is now submitted for the combined Public Enquiry and Vote
phase of the ETSI standards EN Approval Procedure.
The present document has been prepared 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.

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

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

---------------------- Page: 6 ----------------------
7 Draft ETSI EN 302 510 V2.0.1 (2016-09)
Introduction
Membrane Implants and associated peripheral equipment are a new technology in the medical field that provides, on a
continuing non-invasive basis after the implant is inserted, patient related real time intravenous blood pressure
information to the attending physician. This information is used for purposes of diagnosing and treating certain heart
related disorders thereby reducing significantly the hospital readmission rate.
The present document is a specific product standard applicable to Ultra Low Power Active Medical Membrane Implants
and Peripherals operating in the frequency range 30 MHz to 37,5 MHz.
The frequency usage conditions for the band 30 MHz to 37,5 MHz are EU wide harmonised for the SRD category
"active medical implant devices" according to 2013/752/EU [i.10].
The present document is structured in the following way:
• Clauses 1 through 3 provide a general description on the types of equipment covered by the present document
and the definitions, symbols and abbreviations used.
• Clause 4 provides the technical requirements, specifications, limits and conformance relative to transmitter,
receiver, and spectrum access.
• Clauses 5.1 and 5.2 specify the conditions for testing of the equipment and interpretation of the measurement
results with the maximum measurement uncertainty values.
• Clause 5.3 specifies the required measurement methods. In particular clause 5.3.8 describes the monitoring
system performance specifications that have been chosen to minimize harmful interference to other equipment
or services and minimize the potential for disturbance to this equipment from ambient sources or other medical
device users in the band.
• Annex A (normative) provides the relationship between the present document and the essential requirements
of Directive 2014/53/EU [i.1].
• Annex B (normative) provides specifications concerning radiated measurements.
• Annex C (normative) provides technical performance of the spectrum analyser.
• Annex D (informative) bibliography; provides additional information.

ETSI

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8 Draft ETSI EN 302 510 V2.0.1 (2016-09)
1 Scope
The present document applies to Ultra Low Power-Active Medical Membrane Implants and Membrane Implant
Peripherals as described in Directive 90/385/EEC [i.4], covering all active medical implants, that operate in a Medical
Implant Communications System in the frequency band 30 MHz to 37,5 MHz.
Table 1: Ultra Low Power Active Medical Membrane Implants and
Peripherals operating in the frequency band 30 MHz to 37,5 MHz
Ultra Low Power Active Medical Membrane Implants

and Peripherals service frequency bands
Transmitters - Ultra Low Power Active Medical
30 MHz to 37,5 MHz
Membrane Implants and peripherals
Receivers - Ultra Low Power Active Medical
30 MHz to 37,5 MHz
Membrane Implants and peripherals

The present document contains the technical requirements for characteristics of ULP-AMI-M and ULP-AMI-M-P radio
equipment which are aligned with annex 12 Sub-band (d) of CEPT/ERC Recommendation 70-03 [i.6].
The frequency usage conditions for the band 30 MHz to 37,5 MHz are EU wide harmonised for the SRD category
"active medical implant devices" according to 2013/752/EU [i.10] with the following usage restrictions:
• "This set of usage conditions is only available to ultra-low power medical membrane implants for blood
pressure measurements within the definition of active implantable medical devices in Directive 90/385/EEC."
The present document contains requirements to demonstrate that Ultra Low Power Active Medical Membrane Implants
and peripherals used in a medical membrane implant communications system "… shall be so constructed that it both
effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference" (article 3.2 of
the Directive 2014/53/EU [i.1]). It does not necessarily include all the characteristics, which may be required by a user,
nor does it necessarily represent the optimum performance achievable.
2 References
2.1 Normative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
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] CISPR 16-2-3 (2010): "Specification for radio disturbance and immunity measuring apparatus and
methods. Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance
measurements".
ETSI

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9 Draft ETSI EN 302 510 V2.0.1 (2016-09)
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 A
...