Short Range Devices (SRD) - Radio equipment operating in the frequency range 315 kHz to 600 kHz for Ultra Low Power Animal Implantable Devices (ULP-AID) and associated peripherals - Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU

The present document specifies technical characteristics and methods of measurements for Ultra Low Power-Animal
Implant Devices (ULP-AIDs) and Peripherals as used by industry to develop new drugs and surgical techniques that
provide improved health care for the benefit of human patients. ULP-AIDs operate in a Communications System using
inductive technology in the frequency band 315 kHz to 600 kHz.
The present document contains the technical requirements for characteristics of ULP-AID and ULP-AID-P radio
equipment which are aligned with annex 12 sub-band (c) of CEPT/ERC Recommendation 70-03 [i.3].
The frequency usage conditions for the bands 315 kHz to 600 kHz are EU wide harmonised for the SRD category
"active medical implant devices" according to 2013/752/EU [i.6] with the following usage restrictions:
• "This set of usage conditions is only available to animal implantable devices".
The present document covers the essential requirements of article 3.2 of Directive 2014/53/EU [i.1] under the
conditions identified in annex A for Ultra Low Power Animal Implants and peripherals used in an implant
communications system that supports development of medically related treatments that provide improved health care
for patients. It does not necessarily include all the characteristics, which may be required by a user, nor does it
necessarily represent the optimum performance achievable.

Naprave kratkega dosega (SRD) - Radijska oprema za živalske pripomočke za vsaditev ultra majhnih moči (ULP-AID) in pripadajoče periferne naprave, ki delujejo v frekvenčnem območju od 315 kHz do 600 kHz - Harmonizirani standard, ki zajema bistvene zahteve člena 3.2 direktive 2014/53/EU

Ta dokument določa tehnične lastnosti in metode merjenja za živalske pripomočke za vsaditev ultra majhnih moči (ULP-AID) in periferne naprave, kot se uporabljajo v panogi za razvoj novih zdravil in kirurških tehnik, ki zagotavljajo izboljšano zdravstveno nego v korist bolnikov. Živalski pripomočki za vsaditev ultra majhnih moči delujejo v komunikacijskem sistemu s pomočjo induktivne tehnologije in v frekvenčnem pasu od 315 kHz do 600 kHz.
Ta dokument vsebuje tehnične zahteve za lastnosti radijske opreme živalskih pripomočkov za vsaditev ultra majhnih moči ter pripadajočih perifernih naprav, ki so skladne s poddelom (c) dodatka 12 priporočila CEPT/ERC 70-03 [i.3].
Pogoji uporabe frekvenc za pasove od 315 kHz do 600 kHz so v skladu s sklepom Komisije 2013/752/EU [i.6] v celotni Evropski uniji usklajeni za kategorijo naprav kratkega dosega »aktivni medicinski pripomočki za vsaditev« z naslednjimi omejitvami uporabe:
• »Ta niz pogojev uporabe je na voljo samo za živalske pripomočke za vsaditev«.
Ta dokument zajema bistvene zahteve člena 3.2 direktive 2014/53/EU [i.1] pod pogoji iz dodatka A za živalske pripomočke za vsaditev ultra majhnih moči in pripadajoče periferne naprave, ki se uporabljajo v komunikacijskem sistemu vsadkov, ki podpira razvoj medicinsko povezanih posegov, ki zagotavljajo izboljšano zdravstveno nego za bolnike. Ne vključuje nujno vseh lastnosti, ki bi jih lahko potreboval uporabnik, in ne predstavlja nujno optimalnega delovanja.

General Information

Status
Published
Public Enquiry End Date
28-Feb-2017
Publication Date
07-Nov-2017
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
23-Oct-2017
Due Date
28-Dec-2017
Completion Date
08-Nov-2017

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ETSI EN 302 536 V2.1.1 (2017-10) - Short Range Devices (SRD); Radio equipment operating in the frequency range 315 kHz to 600 kHz for Ultra Low Power Animal Implantable Devices (ULP-AID) and associated peripherals; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU
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ETSI EN 302 536 V2.1.0 (2017-08) - Short Range Devices (SRD); Radio equipment operating in the frequency range 315 kHz to 600 kHz for Ultra Low Power Animal Implantable Devices (ULP-AID) and associated peripherals; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU
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ETSI EN 302 536 V2.0.1 (2016-12) - Short Range Devices (SRD); Radio equipment operating in the frequency range 315 kHz to 600 kHz for Ultra Low Power Animal Implantable Devices (ULP-AID) and associated peripherals; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Short Range Devices (SRD) - Radio equipment operating in the frequency range 315 kHz to 600 kHz for Ultra Low Power Animal Implantable Devices (ULP-AID) and associated peripherals - Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU33.060.99Druga oprema za radijske komunikacijeOther equipment for radiocommunicationsICS:Ta slovenski standard je istoveten z:ETSI EN 302 536 V2.1.1 (2017-10)SIST EN 302 536 V2.1.1:2017en01-december-2017SIST EN 302 536 V2.1.1:2017SLOVENSKI

STANDARD
SIST EN 302 536 V2.1.1:2017

ETSI EN 302 536 V2.1.1 (2017-10) Short Range Devices (SRD); Radio equipment operating in the frequency range 315 kHz to 600 kHz for Ultra Low Power Animal Implantable Devices (ULP-AID) and associated peripherals; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU

HARMONISED EUROPEAN STANDARD SIST EN 302 536 V2.1.1:2017
ETSI ETSI EN 302 536 V2.1.1 (2017-10) 2

Reference REN/ERM-TG30-309 Keywords harmonised standard, inductive, 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.

© ETSI 2017. All rights reserved.

DECTTM, PLUGTESTSTM, UMTSTM and the ETSI logo are trademarks of ETSI registered for the benefit of its Members. 3GPPTM and LTE™ are trademarks of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. oneM2M logo is protected for the benefit of its Members. GSM® and the GSM logo are trademarks registered and owned by the GSM Association. SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 3 Contents Intellectual Property Rights ................................................................................................................................ 6 Foreword ............................................................................................................................................................. 6 Modal verbs terminology .................................................................................................................................... 6 Introduction ........................................................................................................................................................ 7 1 Scope ........................................................................................................................................................ 8 2 References ................................................................................................................................................ 8 2.1 Normative references ......................................................................................................................................... 8 2.2 Informative references ........................................................................................................................................ 8 3 Definitions, symbols and abbreviations ................................................................................................... 9 3.1 Definitions .......................................................................................................................................................... 9 3.2 Symbols ............................................................................................................................................................ 10 3.3 Abbreviations ................................................................................................................................................... 10 4 Technical requirements specifications ................................................................................................... 10 4.1 Environmental profile ....................................................................................................................................... 10 4.1.0 General requirements .................................................................................................................................. 10 4.1.1 Conformance requirements ......................................................................................................................... 11 4.2 Transmitter requirements ................................................................................................................................. 11 4.2.1 Radiated Field Strength .............................................................................................................................. 11 4.2.1.1 Definition .............................................................................................................................................. 11 4.2.1.2 Limits .................................................................................................................................................... 11 4.2.1.3 Conformance ......................................................................................................................................... 11 4.2.2 Permitted range of modulation bandwidth .................................................................................................. 11 4.2.2.0 General .................................................................................................................................................. 11 4.2.2.1 Definition .............................................................................................................................................. 11 4.2.2.2 Limits .................................................................................................................................................... 11 4.2.2.3 Conformance ......................................................................................................................................... 11 4.2.3 Transmitter Spurious emissions .................................................................................................................. 12 4.2.3.1 Definition .............................................................................................................................................. 12 4.2.3.2 Limits .................................................................................................................................................... 12 4.2.3.3 Conformance ......................................................................................................................................... 12 4.2.4 Duty Cycle .................................................................................................................................................. 12 4.2.4.1 Definition .............................................................................................................................................. 12 4.2.4.2 Limits .................................................................................................................................................... 12 4.2.4.3 Conformance ......................................................................................................................................... 12 4.3 Receiver requirements ...................................................................................................................................... 13 4.3.1 Receiver Classification ............................................................................................................................... 13 4.3.2 Receiver Blocking ...................................................................................................................................... 13 4.3.2.1 Definition .............................................................................................................................................. 13 4.3.2.2 Limits .................................................................................................................................................... 13 4.3.2.3 Conformance ......................................................................................................................................... 13 4.3.3 Receiver spurious radiations ....................................................................................................................... 14 4.3.3.0 General .................................................................................................................................................. 14 4.3.3.1 Definition .............................................................................................................................................. 14 4.3.3.2 Limits .................................................................................................................................................... 14 4.3.3.3 Conformance ......................................................................................................................................... 14 5 Testing for compliance with technical requirements .............................................................................. 14 5.0 General requirement ......................................................................................................................................... 14 5.1 Normal test signals and test modulation ........................................................................................................... 14 5.1.0 General requirement ................................................................................................................................... 14 5.1.1 Normal test signals for data ........................................................................................................................ 14 5.2 Antenna ............................................................................................................................................................ 15 5.2.0 General remark ........................................................................................................................................... 15 5.2.1 Artificial antenna ........................................................................................................................................ 15 SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 4 5.3 Test fixture ....................................................................................................................................................... 15 5.3.0 General remark ........................................................................................................................................... 15 5.3.1 Alternate test fixture for equipment intended to be implanted within and transmitters worn on the body of the animal ...................................................................................................................................... 16 5.4 Test sites and general arrangements for radiated measurements ...................................................................... 16 5.5 Modes of operation of the transmitter .............................................................................................................. 16 5.5.0 General remark ........................................................................................................................................... 16 5.5.1 Presentation of equipment for testing purposes .......................................................................................... 16 5.5.2 Choice of model for testing ........................................................................................................................ 17 5.5.3 Presentation of equipment that does not have an external 50 Ω RF connector (integral antenna equipment) .................................................................................................................................................. 17 5.5.3.0 General remark ...................................................................................................................................... 17 5.5.3.1 Equipment with an internal permanent or temporary antenna connector .............................................. 17 5.5.3.2 Equipment with a temporary antenna connector ................................................................................... 17 5.5.4 Controls ...................................................................................................................................................... 17 5.5.5 Transmitter shut-off facility ........................................................................................................................ 17 5.5.6 Receiver power save capability .................................................................................................................. 17 5.5.7 Declarations by the Applicant ..................................................................................................................... 18 5.5.8 Auxiliary test equipment ............................................................................................................................. 18 5.6 Normal and extreme test conditions ................................................................................................................. 18 5.6.0 General remark ........................................................................................................................................... 18 5.6.1 Test power source ....................................................................................................................................... 18 5.6.2 External test power source .......................................................................................................................... 18 5.6.3 Internal test power source ........................................................................................................................... 18 5.7 Normal test conditions ...................................................................................................................................... 19 5.7.1 Normal temperature and humidity .............................................................................................................. 19 5.7.2 Normal test power source ........................................................................................................................... 19 5.7.2.1 Mains voltage ........................................................................................................................................ 19 5.7.2.2 Regulated lead-acid battery power sources ........................................................................................... 19 5.7.2.3 Other power sources .............................................................................................................................. 19 5.8 Extreme test conditions .................................................................................................................................... 20 5.8.1 Extreme temperatures ................................................................................................................................. 20 5.8.1.1 Procedure for tests at extreme temperatures .......................................................................................... 20 5.8.1.2 Procedure for equipment designed for continuous operation ................................................................ 20 5.8.1.3 Procedure for equipment designed for intermittent operation ............................................................... 20 5.8.1.4 Extreme temperature ranges .................................................................................................................. 21 5.8.2 Extreme test source voltages ....................................................................................................................... 21 5.8.2.1 Mains voltage ........................................................................................................................................ 21 5.8.2.2 Regulated lead-acid battery power sources ........................................................................................... 21 5.8.2.3 Power sources using other types of batteries ......................................................................................... 21 5.8.2.4 Other power sources .............................................................................................................................. 22 5.9 Test sites and general arrangements for radiated measurements ...................................................................... 22 5.10 Measuring receiver ........................................................................................................................................... 22 5.11 Interpretation of the measurement results ........................................................................................................ 22 5.12 Transmitter measurements................................................................................................................................ 23 5.12.0 General remark ........................................................................................................................................... 23 5.12.1 Transmitter design specifications ............................................................................................................... 23 5.12.1.0 Antenna requirements ........................................................................................................................... 23 5.12.1.1 The inductive loop coil transmitters ...................................................................................................... 23 5.12.1.2 Antenna type ......................................................................................................................................... 24 5.12.2 Radiated Field Strength .............................................................................................................................. 24 5.12.2.1 Radiated H-field .................................................................................................................................... 24 5.12.2.1.1 General remark ................................................................................................................................ 24 5.12.2.1.2 Methods of measurement................................................................................................................. 24 5.12.3 Permitted frequency range of the modulation bandwidth ........................................................................... 25 5.12.3.1 General remark ...................................................................................................................................... 25 5.12.3.2 Method of measurement ........................................................................................................................ 25 5.12.4 Transmitter Spurious emissions .................................................................................................................. 25 5.12.4.1 Radiated field strength .......................................................................................................................... 25 5.12.4.1.1 Methods of measurement (< 30 MHz)............................................................................................. 25 5.12.5 Duty cycle ................................................................................................................................................... 26 5.12.5.1 Declaration ............................................................................................................................................ 26 SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 5 5.13 Receiver Requirement ...................................................................................................................................... 26 5.13.1 Receiver spurious radiation......................................................................................................................... 26 5.13.1.1 General remark ...................................................................................................................................... 26 5.13.1.2 Methods of measurement ...................................................................................................................... 26 5.14 Receiver Blocking ............................................................................................................................................ 26 5.14.1 Measurement procedure .............................................................................................................................. 26 Annex A (informative):

Relationship between the present document and the essential requirements of Directive 2014/53/EU ......................................................... 28 Annex B (normative):

Radiated measurements ................................................................................ 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 animal body but external to it ........................................................... 30 B.1.1.3 Active medical implant equipment (ULP-AID) .......................................................................................... 30 B.1.2 Test antenna ...................................................................................................................................................... 31 B.1.2.1 Below 30 MHz ............................................................................................................................................ 31 B.1.3 Optional additional indoor site ......................................................................................................................... 31 B.2 Guidance on the use of radiation test sites ............................................................................................. 32 B.2.0 General ............................................................................................................................................................. 32 B.2.1 Measuring distance ........................................................................................................................................... 32 B.2.2 Auxiliary cables ................................................................................................................................................ 32 Annex C (normative):

H-field measurements at distances other than 10 m ................................... 33 Annex D (informative):

Bibliography ................................................................................................... 35 Annex E (informative):

Change History .............................................................................................. 36 History .............................................................................................................................................................. 37

SIST EN 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 6 Intellectual Property Rights Essential patents

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. 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 standardization request C (2015) 5376 final [i.4] 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: 9 October 2017 Date of latest announcement of this EN (doa): 31 January 2018 Date of latest publication of new National Standard or endorsement of this EN (dop/e):

31 July 2018 Date of withdrawal of any conflicting National Standard (dow): 31 July 2019

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 302 536 V2.1.1:2017

ETSI ETSI EN 302 536 V2.1.1 (2017-10) 7 Introduction Animal Implant Devices (AIDs) and associated peripheral equipment are a technology in the medical field that supports the development of new drugs and surgical procedures that are under development by pharmaceutical firms, medically related research college and university institutions. AIDs provide, on a continuing basis, data related to the physical effects of new drugs and the efficacy of new surgical procedures after the implant is inserted. These animals are typically housed in commercial surroundings such as laboratory environments or similar facilities such as colleges and universities. The present document is structured as follows: • Clauses 1 through 3 provide a general description of the types of equipment covered by the present document and the definitions of terms and symbols and abbreviations used. • Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access.

• Clause 5 specifies the methods of measurement for the parameters specified in clause 4. • Annex A (informative) 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 relationship between the radiating H-field and measurement distance. • Annex D (informative) bibliography; provides additional information.

SIST EN 302 536 V2.1.1:2017
ETSI ETSI EN 302 536 V2.1.1 (2017-10) 8 1 Scope The
...

ETSI EN 302 536 V2.1.1 (2017-10)
HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Radio equipment operating in the frequency range
315 kHz to 600 kHz for Ultra Low Power Animal
Implantable Devices (ULP-AID) and associated peripherals;
Harmonised Standard covering the essential requirements of
article 3.2 of Directive 2014/53/EU
---------------------- Page: 1 ----------------------
2 ETSI EN 302 536 V2.1.1 (2017-10)
Reference
REN/ERM-TG30-309
Keywords
harmonised standard, inductive, 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.
© ETSI 2017.
All rights reserved.
TM TM TM

DECT , PLUGTESTS , UMTS and the ETSI logo are trademarks of ETSI registered for the benefit of its Members.

3GPP and LTE™ are trademarks of ETSI registered for the benefit of its Members and

of the 3GPP Organizational Partners.
oneM2M logo is protected for the benefit of its Members.

GSM® and the GSM logo are trademarks registered and owned by the GSM Association.

ETSI
---------------------- Page: 2 ----------------------
3 ETSI EN 302 536 V2.1.1 (2017-10)
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 ............................................................................................................................................................ 10

3.3 Abbreviations ................................................................................................................................................... 10

4 Technical requirements specifications ................................................................................................... 10

4.1 Environmental profile ....................................................................................................................................... 10

4.1.0 General requirements .................................................................................................................................. 10

4.1.1 Conformance requirements ......................................................................................................................... 11

4.2 Transmitter requirements ................................................................................................................................. 11

4.2.1 Radiated Field Strength .............................................................................................................................. 11

4.2.1.1 Definition .............................................................................................................................................. 11

4.2.1.2 Limits .................................................................................................................................................... 11

4.2.1.3 Conformance ......................................................................................................................................... 11

4.2.2 Permitted range of modulation bandwidth .................................................................................................. 11

4.2.2.0 General .................................................................................................................................................. 11

4.2.2.1 Definition .............................................................................................................................................. 11

4.2.2.2 Limits .................................................................................................................................................... 11

4.2.2.3 Conformance ......................................................................................................................................... 11

4.2.3 Transmitter Spurious emissions .................................................................................................................. 12

4.2.3.1 Definition .............................................................................................................................................. 12

4.2.3.2 Limits .................................................................................................................................................... 12

4.2.3.3 Conformance ......................................................................................................................................... 12

4.2.4 Duty Cycle .................................................................................................................................................. 12

4.2.4.1 Definition .............................................................................................................................................. 12

4.2.4.2 Limits .................................................................................................................................................... 12

4.2.4.3 Conformance ......................................................................................................................................... 12

4.3 Receiver requirements ...................................................................................................................................... 13

4.3.1 Receiver Classification ............................................................................................................................... 13

4.3.2 Receiver Blocking ...................................................................................................................................... 13

4.3.2.1 Definition .............................................................................................................................................. 13

4.3.2.2 Limits .................................................................................................................................................... 13

4.3.2.3 Conformance ......................................................................................................................................... 13

4.3.3 Receiver spurious radiations ....................................................................................................................... 14

4.3.3.0 General .................................................................................................................................................. 14

4.3.3.1 Definition .............................................................................................................................................. 14

4.3.3.2 Limits .................................................................................................................................................... 14

4.3.3.3 Conformance ......................................................................................................................................... 14

5 Testing for compliance with technical requirements .............................................................................. 14

5.0 General requirement ......................................................................................................................................... 14

5.1 Normal test signals and test modulation ........................................................................................................... 14

5.1.0 General requirement ................................................................................................................................... 14

5.1.1 Normal test signals for data ........................................................................................................................ 14

5.2 Antenna ............................................................................................................................................................ 15

5.2.0 General remark ........................................................................................................................................... 15

5.2.1 Artificial antenna ........................................................................................................................................ 15

ETSI
---------------------- Page: 3 ----------------------
4 ETSI EN 302 536 V2.1.1 (2017-10)

5.3 Test fixture ....................................................................................................................................................... 15

5.3.0 General remark ........................................................................................................................................... 15

5.3.1 Alternate test fixture for equipment intended to be implanted within and transmitters worn on the

body of the animal ...................................................................................................................................... 16

5.4 Test sites and general arrangements for radiated measurements ...................................................................... 16

5.5 Modes of operation of the transmitter .............................................................................................................. 16

5.5.0 General remark ........................................................................................................................................... 16

5.5.1 Presentation of equipment for testing purposes .......................................................................................... 16

5.5.2 Choice of model for testing ........................................................................................................................ 17

5.5.3 Presentation of equipment that does not have an external 50 Ω RF connector (integral antenna

equipment) .................................................................................................................................................. 17

5.5.3.0 General remark ...................................................................................................................................... 17

5.5.3.1 Equipment with an internal permanent or temporary antenna connector .............................................. 17

5.5.3.2 Equipment with a temporary antenna connector ................................................................................... 17

5.5.4 Controls ...................................................................................................................................................... 17

5.5.5 Transmitter shut-off facility ........................................................................................................................ 17

5.5.6 Receiver power save capability .................................................................................................................. 17

5.5.7 Declarations by the Applicant ..................................................................................................................... 18

5.5.8 Auxiliary test equipment ............................................................................................................................. 18

5.6 Normal and extreme test conditions ................................................................................................................. 18

5.6.0 General remark ........................................................................................................................................... 18

5.6.1 Test power source ....................................................................................................................................... 18

5.6.2 External test power source .......................................................................................................................... 18

5.6.3 Internal test power source ........................................................................................................................... 18

5.7 Normal test conditions ...................................................................................................................................... 19

5.7.1 Normal temperature and humidity .............................................................................................................. 19

5.7.2 Normal test power source ........................................................................................................................... 19

5.7.2.1 Mains voltage ........................................................................................................................................ 19

5.7.2.2 Regulated lead-acid battery power sources ........................................................................................... 19

5.7.2.3 Other power sources .............................................................................................................................. 19

5.8 Extreme test conditions .................................................................................................................................... 20

5.8.1 Extreme temperatures ................................................................................................................................. 20

5.8.1.1 Procedure for tests at extreme temperatures .......................................................................................... 20

5.8.1.2 Procedure for equipment designed for continuous operation ................................................................ 20

5.8.1.3 Procedure for equipment designed for intermittent operation ............................................................... 20

5.8.1.4 Extreme temperature ranges .................................................................................................................. 21

5.8.2 Extreme test source voltages ....................................................................................................................... 21

5.8.2.1 Mains voltage ........................................................................................................................................ 21

5.8.2.2 Regulated lead-acid battery power sources ........................................................................................... 21

5.8.2.3 Power sources using other types of batteries ......................................................................................... 21

5.8.2.4 Other power sources .............................................................................................................................. 22

5.9 Test sites and general arrangements for radiated measurements ...................................................................... 22

5.10 Measuring receiver ........................................................................................................................................... 22

5.11 Interpretation of the measurement results ........................................................................................................ 22

5.12 Transmitter measurements................................................................................................................................ 23

5.12.0 General remark ........................................................................................................................................... 23

5.12.1 Transmitter design specifications ............................................................................................................... 23

5.12.1.0 Antenna requirements ........................................................................................................................... 23

5.12.1.1 The inductive loop coil transmitters ...................................................................................................... 23

5.12.1.2 Antenna type ......................................................................................................................................... 24

5.12.2 Radiated Field Strength .............................................................................................................................. 24

5.12.2.1 Radiated H-field .................................................................................................................................... 24

5.12.2.1.1 General remark ................................................................................................................................ 24

5.12.2.1.2 Methods of measurement................................................................................................................. 24

5.12.3 Permitted frequency range of the modulation bandwidth ........................................................................... 25

5.12.3.1 General remark ...................................................................................................................................... 25

5.12.3.2 Method of measurement ........................................................................................................................ 25

5.12.4 Transmitter Spurious emissions .................................................................................................................. 25

5.12.4.1 Radiated field strength .......................................................................................................................... 25

5.12.4.1.1 Methods of measurement (< 30 MHz)............................................................................................. 25

5.12.5 Duty cycle ................................................................................................................................................... 26

5.12.5.1 Declaration ............................................................................................................................................ 26

ETSI
---------------------- Page: 4 ----------------------
5 ETSI EN 302 536 V2.1.1 (2017-10)

5.13 Receiver Requirement ...................................................................................................................................... 26

5.13.1 Receiver spurious radiation......................................................................................................................... 26

5.13.1.1 General remark ...................................................................................................................................... 26

5.13.1.2 Methods of measurement ...................................................................................................................... 26

5.14 Receiver Blocking ............................................................................................................................................ 26

5.14.1 Measurement procedure .............................................................................................................................. 26

Annex A (informative): Relationship between the present document and the essential

requirements of Directive 2014/53/EU ......................................................... 28

Annex B (normative): Radiated measurements ................................................................................ 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 animal body but external to it ........................................................... 30

B.1.1.3 Active medical implant equipment (ULP-AID) .......................................................................................... 30

B.1.2 Test antenna ...................................................................................................................................................... 31

B.1.2.1 Below 30 MHz ............................................................................................................................................ 31

B.1.3 Optional additional indoor site ......................................................................................................................... 31

B.2 Guidance on the use of radiation test sites ............................................................................................. 32

B.2.0 General ............................................................................................................................................................. 32

B.2.1 Measuring distance ........................................................................................................................................... 32

B.2.2 Auxiliary cables ................................................................................................................................................ 32

Annex C (normative): H-field measurements at distances other than 10 m ................................... 33

Annex D (informative): Bibliography ................................................................................................... 35

Annex E (informative): Change History .............................................................................................. 36

History .............................................................................................................................................................. 37

ETSI
---------------------- Page: 5 ----------------------
6 ETSI EN 302 536 V2.1.1 (2017-10)
Intellectual Property Rights
Essential patents

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.
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 standardization request C (2015) 5376 final [i.4] 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: 9 October 2017
Date of latest announcement of this EN (doa): 31 January 2018
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 July 2018
Date of withdrawal of any conflicting National Standard (dow): 31 July 2019
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 ETSI EN 302 536 V2.1.1 (2017-10)
Introduction

Animal Implant Devices (AIDs) and associated peripheral equipment are a technology in the medical field that supports

the development of new drugs and surgical procedures that are under development by pharmaceutical firms, medically

related research college and university institutions. AIDs provide, on a continuing basis, data related to the physical

effects of new drugs and the efficacy of new surgical procedures after the implant is inserted. These animals are

typically housed in commercial surroundings such as laboratory environments or similar facilities such as colleges and

universities.
The present document is structured as follows:

• Clauses 1 through 3 provide a general description of the types of equipment covered by the present document

and the definitions of terms and symbols and abbreviations used.

• Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access.

• Clause 5 specifies the methods of measurement for the parameters specified in clause 4.

• Annex A (informative) 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 relationship between the radiating H-field and measurement distance.

• Annex D (informative) bibliography; provides additional information.
ETSI
---------------------- Page: 7 ----------------------
8 ETSI EN 302 536 V2.1.1 (2017-10)
1 Scope

The present document specifies technical characteristics and methods of measurements for Ultra Low Power-Animal

Implant Devices (ULP-AIDs) and Peripherals as used by industry t
...

Final draft ETSI EN 302 536 V2.1.0 (2017-08)
HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Radio equipment operating in the frequency range
315 kHz to 600 kHz for Ultra Low Power Animal
Implantable Devices (ULP-AID) and associated peripherals;
Harmonised Standard covering the essential requirements of
article 3.2 of Directive 2014/53/EU
---------------------- Page: 1 ----------------------
2 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
Reference
REN/ERM-TG30-309
Keywords
harmonised standard, inductive, 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.
© ETSI 2017.
All rights reserved.
TM TM TM

DECT , PLUGTESTS , UMTS and the ETSI logo are trademarks of ETSI registered for the benefit of its Members.

3GPP and LTE™ are trademarks of ETSI registered for the benefit of its Members and

of the 3GPP Organizational Partners.
oneM2M logo is protected for the benefit of its Members.

GSM® and the GSM logo are trademarks registered and owned by the GSM Association.

ETSI
---------------------- Page: 2 ----------------------
3 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
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 ............................................................................................................................................................ 10

3.3 Abbreviations ................................................................................................................................................... 10

4 Technical requirements specifications ................................................................................................... 10

4.1 Environmental profile ....................................................................................................................................... 10

4.1.0 General requirements .................................................................................................................................. 10

4.1.1 Conformance requirements ......................................................................................................................... 11

4.2 Transmitter requirements ................................................................................................................................. 11

4.2.1 Radiated Field Strength .............................................................................................................................. 11

4.2.1.1 Definition .............................................................................................................................................. 11

4.2.1.2 Limits .................................................................................................................................................... 11

4.2.1.3 Conformance ......................................................................................................................................... 11

4.2.2 Permitted range of modulation bandwidth .................................................................................................. 11

4.2.2.0 General .................................................................................................................................................. 11

4.2.2.1 Definition .............................................................................................................................................. 11

4.2.2.2 Limits .................................................................................................................................................... 11

4.2.2.3 Conformance ......................................................................................................................................... 11

4.2.3 Transmitter Spurious emissions .................................................................................................................. 12

4.2.3.1 Definition .............................................................................................................................................. 12

4.2.3.2 Limits .................................................................................................................................................... 12

4.2.3.3 Conformance ......................................................................................................................................... 12

4.2.4 Duty Cycle .................................................................................................................................................. 12

4.2.4.1 Definition .............................................................................................................................................. 12

4.2.4.2 Limits .................................................................................................................................................... 12

4.2.4.3 Conformance ......................................................................................................................................... 12

4.3 Receiver requirements ...................................................................................................................................... 13

4.3.1 Receiver Classification ............................................................................................................................... 13

4.3.2 Receiver Blocking ...................................................................................................................................... 13

4.3.2.1 Definition .............................................................................................................................................. 13

4.3.2.2 Limits .................................................................................................................................................... 13

4.3.2.3 Conformance ......................................................................................................................................... 13

4.3.3 Receiver spurious radiations ....................................................................................................................... 14

4.3.3.0 General .................................................................................................................................................. 14

4.3.3.1 Definition .............................................................................................................................................. 14

4.3.3.2 Limits .................................................................................................................................................... 14

4.3.3.3 Conformance ......................................................................................................................................... 14

5 Testing for compliance with technical requirements .............................................................................. 14

5.0 General requirement ......................................................................................................................................... 14

5.1 Normal test signals and test modulation ........................................................................................................... 14

5.1.0 General requirement ................................................................................................................................... 14

5.1.1 Normal test signals for data ........................................................................................................................ 14

5.2 Antenna ............................................................................................................................................................ 15

5.2.0 General remark ........................................................................................................................................... 15

5.2.1 Artificial antenna ........................................................................................................................................ 15

ETSI
---------------------- Page: 3 ----------------------
4 Final draft ETSI EN 302 536 V2.1.0 (2017-08)

5.3 Test fixture ....................................................................................................................................................... 15

5.3.0 General remark ........................................................................................................................................... 15

5.3.1 Alternate test fixture for equipment intended to be implanted within and transmitters worn on the

body of the animal ...................................................................................................................................... 16

5.4 Test sites and general arrangements for radiated measurements ...................................................................... 16

5.5 Modes of operation of the transmitter .............................................................................................................. 16

5.5.0 General remark ........................................................................................................................................... 16

5.5.1 Presentation of equipment for testing purposes .......................................................................................... 16

5.5.2 Choice of model for testing ........................................................................................................................ 17

5.5.3 Presentation of equipment that does not have an external 50 Ω RF connector (integral antenna

equipment) .................................................................................................................................................. 17

5.5.3.0 General remark ...................................................................................................................................... 17

5.5.3.1 Equipment with an internal permanent or temporary antenna connector .............................................. 17

5.5.3.2 Equipment with a temporary antenna connector ................................................................................... 17

5.5.4 Controls ...................................................................................................................................................... 17

5.5.5 Transmitter shut-off facility ........................................................................................................................ 17

5.5.6 Receiver power save capability .................................................................................................................. 17

5.5.7 Declarations by the Applicant ..................................................................................................................... 18

5.5.8 Auxiliary test equipment ............................................................................................................................. 18

5.6 Normal and extreme test conditions ................................................................................................................. 18

5.6.0 General remark ........................................................................................................................................... 18

5.6.1 Test power source ....................................................................................................................................... 18

5.6.2 External test power source .......................................................................................................................... 18

5.6.3 Internal test power source ........................................................................................................................... 18

5.7 Normal test conditions ...................................................................................................................................... 19

5.7.1 Normal temperature and humidity .............................................................................................................. 19

5.7.2 Normal test power source ........................................................................................................................... 19

5.7.2.1 Mains voltage ........................................................................................................................................ 19

5.7.2.2 Regulated lead-acid battery power sources ........................................................................................... 19

5.7.2.3 Other power sources .............................................................................................................................. 19

5.8 Extreme test conditions .................................................................................................................................... 20

5.8.1 Extreme temperatures ................................................................................................................................. 20

5.8.1.1 Procedure for tests at extreme temperatures .......................................................................................... 20

5.8.1.2 Procedure for equipment designed for continuous operation ................................................................ 20

5.8.1.3 Procedure for equipment designed for intermittent operation ............................................................... 20

5.8.1.4 Extreme temperature ranges .................................................................................................................. 21

5.8.2 Extreme test source voltages ....................................................................................................................... 21

5.8.2.1 Mains voltage ........................................................................................................................................ 21

5.8.2.2 Regulated lead-acid battery power sources ........................................................................................... 21

5.8.2.3 Power sources using other types of batteries ......................................................................................... 21

5.8.2.4 Other power sources .............................................................................................................................. 22

5.9 Test sites and general arrangements for radiated measurements ...................................................................... 22

5.10 Measuring receiver ........................................................................................................................................... 22

5.11 Interpretation of the measurement results ........................................................................................................ 22

5.12 Transmitter measurements................................................................................................................................ 23

5.12.0 General remark ........................................................................................................................................... 23

5.12.1 Transmitter design specifications ............................................................................................................... 23

5.12.1.0 Antenna requirements ........................................................................................................................... 23

5.12.1.1 The inductive loop coil transmitters ...................................................................................................... 23

5.12.1.2 Antenna type ......................................................................................................................................... 24

5.12.2 Radiated Field Strength .............................................................................................................................. 24

5.12.2.1 Radiated H-field .................................................................................................................................... 24

5.12.2.1.1 General remark ................................................................................................................................ 24

5.12.2.1.2 Methods of measurement................................................................................................................. 24

5.12.3 Permitted frequency range of the modulation bandwidth ........................................................................... 25

5.12.3.1 General remark ...................................................................................................................................... 25

5.12.3.2 Method of measurement ........................................................................................................................ 25

5.12.4 Transmitter Spurious emissions .................................................................................................................. 25

5.12.4.1 Radiated field strength .......................................................................................................................... 25

5.12.4.1.1 Methods of measurement (< 30 MHz)............................................................................................. 25

5.12.5 Duty cycle ................................................................................................................................................... 26

5.12.5.1 Declaration ............................................................................................................................................ 26

ETSI
---------------------- Page: 4 ----------------------
5 Final draft ETSI EN 302 536 V2.1.0 (2017-08)

5.13 Receiver Requirement ...................................................................................................................................... 26

5.13.1 Receiver spurious radiation......................................................................................................................... 26

5.13.1.1 General remark ...................................................................................................................................... 26

5.13.1.2 Methods of measurement ...................................................................................................................... 26

5.14 Receiver Blocking ............................................................................................................................................ 26

5.14.1 Measurement procedure .............................................................................................................................. 26

Annex A (informative): Relationship between the present document and the essential

requirements of Directive 2014/53/EU ......................................................... 28

Annex B (normative): Radiated measurements ................................................................................ 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 animal body but external to it ........................................................... 30

B.1.1.3 Active medical implant equipment (ULP-AID) .......................................................................................... 30

B.1.2 Test antenna ...................................................................................................................................................... 31

B.1.2.1 Below 30 MHz ............................................................................................................................................ 31

B.1.3 Optional additional indoor site ......................................................................................................................... 31

B.2 Guidance on the use of radiation test sites ............................................................................................. 32

B.2.0 General ............................................................................................................................................................. 32

B.2.1 Measuring distance ........................................................................................................................................... 32

B.2.2 Auxiliary cables ................................................................................................................................................ 32

Annex C (normative): H-field measurements at distances other than 10 m ................................... 33

Annex D (informative): Bibliography ................................................................................................... 35

Annex E (informative): Change History .............................................................................................. 36

History .............................................................................................................................................................. 37

ETSI
---------------------- Page: 5 ----------------------
6 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
Intellectual Property Rights
Essential patents

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.
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 final 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 Vote phase of the

ETSI standards EN Approval Procedure.

The present document has been prepared under the Commission's standardization request C (2015) 5376 final [i.4] 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): 18 months after doa

Modal verbs terminology

In the present document "shall", "shall not", "should", "should not", "may", "need not", "will", "will not", "can" and

"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 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
Introduction

Animal Implant Devices (AIDs) and associated peripheral equipment are a technology in the medical field that supports

the development of new drugs and surgical procedures that are under development by pharmaceutical firms, medically

related research college and university institutions. AIDs provide, on a continuing basis, data related to the physical

effects of new drugs and the efficacy of new surgical procedures after the implant is inserted. These animals are

typically housed in commercial surroundings such as laboratory environments or similar facilities such as colleges and

universities.
The present document is structured as follows:

• Clauses 1 through 3 provide a general description of the types of equipment covered by the present document

and the definitions of terms and symbols and abbreviations used.

• Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access.

• Clause 5 specifies the methods of measurement for the parameters specified in clause 4.

• Annex A (informative) 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 relationship between the radiating H-field and measurement distance.

• Annex D (informative) bibliography; provides additional information.
ETSI
---------------------- Page: 7 ----------------------
8 Final draft ETSI EN 302 536 V2.1.0 (2017-08)
1 Scope
The
...

Draft ETSI EN 302 536 V2.0.1 (2016-12)
HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Radio equipment operating in the frequency range
315 kHz to 600 kHz for Ultra Low Power Animal
Implantable Devices (ULP-AID) and associated peripherals;
Harmonised Standard covering the essential requirements of
article 3.2 of Directive 2014/53/EU
---------------------- Page: 1 ----------------------
2 Draft ETSI EN 302 536 V2.0.1 (2016-12)
Reference
REN/ERM-TG30-309
Keywords
harmonised standard, inductive, 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.

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 302 536 V2.0.1 (2016-12)
Contents

Intellectual Property Rights ................................................................................................................................ 6

Foreword ............................................................................................................................................................. 6

Modal verbs terminology .................................................................................................................................... 6

Introduction ........................................................................................................................................................ 6

1 Scope ........................................................................................................................................................ 8

2 References ................................................................................................................................................ 8

2.1 Normative references ......................................................................................................................................... 8

2.2 Informative references ........................................................................................................................................ 8

3 Definitions, symbols and abbreviations ................................................................................................... 9

3.1 Definitions .......................................................................................................................................................... 9

3.2 Symbols ............................................................................................................................................................ 10

3.3 Abbreviations ................................................................................................................................................... 10

4 Technical requirements specifications ................................................................................................... 10

4.1 Environmental profile ....................................................................................................................................... 10

4.1.0 General requirements .................................................................................................................................. 10

4.1.1 Conformance requirements ......................................................................................................................... 11

4.2 Transmitter requirements ................................................................................................................................. 11

4.2.1 Radiated Field Strength .............................................................................................................................. 11

4.2.1.1 Definition .............................................................................................................................................. 11

4.2.1.2 Limits .................................................................................................................................................... 11

4.2.1.3 Conformance ......................................................................................................................................... 11

4.2.2 Permitted range of modulation bandwidth .................................................................................................. 11

4.2.2.0 General .................................................................................................................................................. 11

4.2.2.1 Definition .............................................................................................................................................. 11

4.2.2.2 Limits .................................................................................................................................................... 11

4.2.2.3 Conformance ......................................................................................................................................... 11

4.2.3 Transmitter Spurious emissions .................................................................................................................. 12

4.2.3.1 Definition .............................................................................................................................................. 12

4.2.3.2 Limits .................................................................................................................................................... 12

4.2.3.3 Conformance ......................................................................................................................................... 12

4.2.4 Duty Cycle .................................................................................................................................................. 12

4.2.4.1 Definition .............................................................................................................................................. 12

4.2.4.2 Limits .................................................................................................................................................... 12

4.2.4.3 Conformance ......................................................................................................................................... 12

4.3 Receiver requirements ...................................................................................................................................... 12

4.3.1 Receiver Classification ............................................................................................................................... 12

4.3.2 Receiver Blocking ...................................................................................................................................... 13

4.3.2.1 Definition .............................................................................................................................................. 13

4.3.2.2 Limits .................................................................................................................................................... 13

4.3.2.3 Conformance ......................................................................................................................................... 13

4.3.3 Receiver spurious radiations ....................................................................................................................... 13

4.3.3.0 General .................................................................................................................................................. 13

4.3.3.1 Definition .............................................................................................................................................. 14

4.3.3.2 Limits .................................................................................................................................................... 14

4.3.3.3 Conformance ......................................................................................................................................... 14

5 Testing for compliance with technical requirements .............................................................................. 14

5.0 General requirement ......................................................................................................................................... 14

5.1 Normal test signals and test modulation ........................................................................................................... 14

5.1.0 General requirement ................................................................................................................................... 14

5.1.1 Normal test signals for data ........................................................................................................................ 14

5.2 Antenna ............................................................................................................................................................ 15

5.2.0 General remark ........................................................................................................................................... 15

5.2.1 Artificial antenna ........................................................................................................................................ 15

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4 Draft ETSI EN 302 536 V2.0.1 (2016-12)

5.3 Test fixture ....................................................................................................................................................... 15

5.3.0 General remark ........................................................................................................................................... 15

5.3.1 Alternate test fixture for equipment intended to be implanted within and transmitters worn on the

body of the animal ...................................................................................................................................... 16

5.4 Test sites and general arrangements for radiated measurements ...................................................................... 16

5.5 Modes of operation of the transmitter .............................................................................................................. 16

5.5.0 General remark ................................................................................................................................................. 16

5.5.1 Presentation of equipment for testing purposes .......................................................................................... 16

5.5.2 Choice of model for testing ........................................................................................................................ 16

5.5.3 Presentation of equipment that does not have an external 50 Ω RF connector (integral antenna

equipment) .................................................................................................................................................. 17

5.5.3.0 General remark ...................................................................................................................................... 17

5.5.3.1 Equipment with an internal permanent or temporary antenna connector .............................................. 17

5.5.3.2 Equipment with a temporary antenna connector ................................................................................... 17

5.5.4 Controls ...................................................................................................................................................... 17

5.5.5 Transmitter shut-off facility ........................................................................................................................ 17

5.5.6 Receiver power save capability .................................................................................................................. 17

5.5.7 Declarations by the Applicant ..................................................................................................................... 17

5.5.8 Auxiliary test equipment ............................................................................................................................. 18

5.6 Normal and extreme test conditions ................................................................................................................. 18

5.6.0 General remark ........................................................................................................................................... 18

5.6.1 Test power source ....................................................................................................................................... 18

5.6.2 External test power source .......................................................................................................................... 18

5.6.3 Internal test power source ........................................................................................................................... 18

5.7 Normal test conditions ...................................................................................................................................... 19

5.7.1 Normal temperature and humidity .............................................................................................................. 19

5.7.2 Normal test power source ........................................................................................................................... 19

5.7.2.1 Mains voltage ........................................................................................................................................ 19

5.7.2.2 Regulated lead-acid battery power sources ........................................................................................... 19

5.7.2.3 Other power sources .............................................................................................................................. 19

5.8 Extreme test conditions .................................................................................................................................... 19

5.8.1 Extreme temperatures ................................................................................................................................. 19

5.8.1.1 Procedure for tests at extreme temperatures .......................................................................................... 19

5.8.1.2 Procedure for equipment designed for continuous operation ................................................................ 20

5.8.1.3 Procedure for equipment designed for intermittent operation ............................................................... 20

5.8.1.4 Extreme temperature ranges .................................................................................................................. 20

5.8.2 Extreme test source voltages ....................................................................................................................... 21

5.8.2.1 Mains voltage ........................................................................................................................................ 21

5.8.2.2 Regulated lead-acid battery power sources ........................................................................................... 21

5.8.2.3 Power sources using other types of batteries ......................................................................................... 21

5.8.2.4 Other power sources .............................................................................................................................. 21

5.9 Test sites and general arrangements for radiated measurements ...................................................................... 22

5.10 Measuring receiver ........................................................................................................................................... 22

5.11 Interpretation of the measurement results ........................................................................................................ 22

5.12 Transmitter measurements................................................................................................................................ 22

5.12.0 General remark ........................................................................................................................................... 22

5.12.1 Transmitter design specifications ............................................................................................................... 23

5.12.1.1 The inductive loop coil transmitters ...................................................................................................... 23

5.12.1.2 Antenna type ......................................................................................................................................... 23

5.12.2 Radiated Field Strength .............................................................................................................................. 24

5.12.2.1 Radiated H-field .................................................................................................................................... 24

5.12.2.1.1 General remark ................................................................................................................................ 24

5.12.2.1.2 Methods of measurement................................................................................................................. 24

5.12.3 Permitted frequency range of the modulation bandwidth ........................................................................... 24

5.12.3.1 General remark ...................................................................................................................................... 24

5.12.3.2 Method of measurement ........................................................................................................................ 25

5.12.4 Transmitter Spurious emissions .................................................................................................................. 25

5.12.4.1 Radiated field strength .......................................................................................................................... 25

5.12.4.1.1 Methods of measurement (< 30 MHz)............................................................................................. 25

5.12.5 Duty cycle ................................................................................................................................................... 25

5.12.5.1 Declaration ............................................................................................................................................ 25

5.13 Receiver Requirement ...................................................................................................................................... 26

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5.13.1 Receiver spurious radiation......................................................................................................................... 26

5.13.1.1 General remark ...................................................................................................................................... 26

5.13.1.2 Methods of measurement ...................................................................................................................... 26

5.14 Receiver Blocking ............................................................................................................................................ 26

5.14.1 Measurement procedure .............................................................................................................................. 26

Annex A (informative): Relationship between the present document and the essential

requirements of Directive 2014/53/EU ......................................................... 28

Annex B (normative): Radiated measurements ................................................................................ 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 ........................................................................................................................................ 30

B.1.1.2 Equipment in close proximity to the animal body but external to it ........................................................... 30

B.1.1.3 Active medical implant equipment (ULP-AID) .......................................................................................... 30

B.1.2 Test antenna ...................................................................................................................................................... 32

B.1.2.1 Below 30 MHz ............................................................................................................................................ 32

B.1.3 Optional additional indoor site ......................................................................................................................... 32

B.2 Guidance on the use of radiation test sites ............................................................................................. 32

B.2.0 General ............................................................................................................................................................. 32

B.2.1 Measuring distance ........................................................................................................................................... 32

B.2.2 Auxiliary cables ................................................................................................................................................ 33

Annex C (normative): H-field measurements at distances other than 10 m ................................... 34

Annex D (informative): Bibliography ................................................................................................... 36

Annex E (informative): Change History .............................................................................................. 37

History .............................................................................................................................................................. 38

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6 Draft ETSI EN 302 536 V2.0.1 (2016-12)
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 standardization request C (2015) 5376 final [i.4] 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): 18 months after doa

Modal verbs terminology

In the present document "shall", "shall not", "should", "should not", "may", "need not", "will", "will not", "can" and

"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.

Introduction

Animal Implant Devices (AIDs) and associated peripheral equipment are a technology in the medical field that supports

the development of new drugs and surgical procedures that are under development by pharmaceutical firms, medically

related research college and university institutions. AIDs provide, on a continuing basis, data related to the physical

effects of new drugs and the efficacy of new surgical procedures after the implant is inserted. These animals are

typically housed in commercial surroundings such as laboratory environments or similar facilities such as colleges and

universities.
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7 Draft ETSI EN 302 536 V2.0.1 (2016-12)
The present document is structured as follows:

• Clauses 1 through 3 provide a general description of the types of equipment covered by the present document

and the definitions of terms and symbols and abbreviations used.

• Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access.

• Clause 5 specifies the methods of measurement for the parameters specified in clause 4.

• Annex A (informative) 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 relationship between the radiating H-field and measurement distance.

• Annex D (informative) bibliography; provides additional information.
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8 Draft ETSI EN 302 536 V2.0.1 (2016-12)
1 Scope

The present document specifies technical characteristics and methods of measurements for Ultra Low Power-Animal

Implant Devices (ULP-AIDs) and Peripherals as used by industry to develop new drugs and surgical techniques that

provide improved health care for the benefit of human patients. ULP-AIDs operate in a Communications System using

inductive technology in the frequency band 315 kHz to 600 kHz.
Table 1: Ultra Low Power Animal Implants and Peripherals
Operating in the frequency band 315 kHz to 600 kHz
Ultra Low Power Animal Implants and
Peripherals service frequency bands
Transmitters - Ultra Low Power Animal
315 kHz to 600 kHz
Implants and Peripherals
...

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