Short Range Devices (SRD) - Ultra Low Power (ULP) wireless medical capsule endoscopy devices operating in the band 430 MHz to 440 MHz - Harmonised Standard for access to radio spectrum

The present document specifies technical characteristics and methods of measurements for Ultra Low Power Wireless
Medical Capsule Endoscopy application (CCam transmitters and associated DR receivers) operating in the designated
frequency band 430 MHz to 440 MHz, as meant by ETSI TR 103 451 [i.3].
A possible return (downlink) RF transmission channel from DR to CCam for command and control signalling, if and
when implemented, is outside the scope of the present document.
NOTE: The relationship between the present document and essential requirements of article 3.2 of
Directive 2014/53/EU [i.2] is given in Annex A.

Naprave kratkega dosega (SRD) - Medicinske naprave ultra male moči za brezžično kapsulno endoskopijo, ki delujejo v pasu od 430 MHz do 440 MHz - Harmonizirani standard za dostop do radijskega spektra

Ta dokument določa tehnične karakteristike in merilne metode za medicinske naprave ultra male moči za brezžično kapsulno endoskopijo (oddajniki CCam in z njimi povezani sprejemniki DR), ki delujejo v namenskem frekvenčnem pasu od 430 MHz do 440 MHz, kot je določeno v tehničnem poročilu ETSI TR 103 451 [i.3]. Možni povratni (navzdolnja povezava) prenosni radiofrekvenčni kanal od DR do CCam za upravljanje in nadzor signala, če/ko bo uporabljen, ne spada na področje uporabe tega dokumenta.
OPOMBA: Razmerje med tem dokumentom in bistvenimi zahtevami člena 3.2 Direktive 2014/53/EU [i.2] je podano v dodatku A.

General Information

Status
Published
Public Enquiry End Date
27-May-2019
Publication Date
04-Jul-2019
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Jul-2019
Due Date
05-Sep-2019
Completion Date
05-Jul-2019

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ETSI EN 303 520 V1.2.1 (2019-06)
HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Ultra Low Power (ULP) wireless medical capsule endoscopy
devices operating in the band 430 MHz to 440 MHz;
Harmonised Standard for access to radio spectrum
---------------------- Page: 1 ----------------------
2 ETSI EN 303 520 V1.2.1 (2019-06)
Reference
REN/ERM-TG30-321
Keywords
harmonised standard
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 prevailing version of an ETSI

deliverable is the one made publicly available in PDF format at www.etsi.org/deliver.

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 2019.
All rights reserved.

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 a trademark of ETSI registered for the benefit of its Members and

of the oneM2M Partners.
GSM and the GSM logo are trademarks registered and owned by the GSM Association.
ETSI
---------------------- Page: 2 ----------------------
3 ETSI EN 303 520 V1.2.1 (2019-06)
Contents

Intellectual Property Rights ................................................................................................................................ 5

Foreword ............................................................................................................................................................. 5

Modal verbs terminology .................................................................................................................................... 5

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

1 Scope ........................................................................................................................................................ 7

2 References ................................................................................................................................................ 7

2.1 Normative references ......................................................................................................................................... 7

2.2 Informative references ........................................................................................................................................ 7

3 Definition of terms, symbols and abbreviations ....................................................................................... 8

3.1 Terms .................................................................................................................................................................. 8

3.2 Symbols .............................................................................................................................................................. 8

3.3 Abbreviations ..................................................................................................................................................... 8

4 Technical requirements specifications ..................................................................................................... 9

4.1 Environmental profile ......................................................................................................................................... 9

4.2 Conformance requirements ................................................................................................................................ 9

4.2.1 Transmitter requirements .............................................................................................................................. 9

4.2.1.1 Effective radiated power ......................................................................................................................... 9

4.2.1.1.1 Definition........................................................................................................................................... 9

4.2.1.1.2 Limit .................................................................................................................................................. 9

4.2.1.1.3 Conformance ..................................................................................................................................... 9

4.2.1.2 Transmitter emissions mask .................................................................................................................... 9

4.2.1.2.1 Definition........................................................................................................................................... 9

4.2.1.2.2 Limits ................................................................................................................................................ 9

4.2.1.2.3 Conformance ................................................................................................................................... 10

4.2.2 Receiver requirements ................................................................................................................................ 10

4.2.2.1 Unwanted Emissions in the Spurious Domain ...................................................................................... 10

4.2.2.1.1 Definition......................................................................................................................................... 10

4.2.2.1.2 Limit ................................................................................................................................................ 10

4.2.2.1.3 Conformance ................................................................................................................................... 10

4.2.2.2 Receiver blocking ................................................................................................................................. 10

4.2.2.2.1 Definition......................................................................................................................................... 10

4.2.2.2.2 Limits .............................................................................................................................................. 11

4.2.2.2.3 Conformance ................................................................................................................................... 11

4.2.2.3 Receiver sensitivity ............................................................................................................................... 11

4.2.2.3.1 Definition......................................................................................................................................... 11

4.2.2.3.2 Limit ................................................................................................................................................ 11

4.2.2.3.3 Conformance ................................................................................................................................... 11

4.2.2.4 Adjacent signal selectivity .................................................................................................................... 11

4.2.2.4.1 Definition......................................................................................................................................... 11

4.2.2.4.2 Limit ................................................................................................................................................ 11

4.2.2.4.3 Conformance ................................................................................................................................... 11

5 Testing for compliance with technical requirements .............................................................................. 12

5.1 Presentation of equipment for testing purposes ................................................................................................ 12

5.1.0 General provisions ...................................................................................................................................... 12

5.1.1 Choice of equipment model for testing ....................................................................................................... 12

5.1.2 Human torso simulator ................................................................................................................................ 12

5.1.3 Testing in external laboratory ..................................................................................................................... 12

5.2 Test conditions ................................................................................................................................................. 12

5.2.1 Test power source ....................................................................................................................................... 12

5.2.2 Temperature and humidity .......................................................................................................................... 13

5.2.3 Test signals and test modulation ................................................................................................................. 13

5.2.4 Antennas ..................................................................................................................................................... 13

5.2.5 Test fixture for CCam ................................................................................................................................. 13

ETSI
---------------------- Page: 3 ----------------------
4 ETSI EN 303 520 V1.2.1 (2019-06)

5.2.6 Test site and general arrangements for radiated measurements .................................................................. 13

5.2.7 Measuring receiver ..................................................................................................................................... 13

5.3 Void .................................................................................................................................................................. 13

5.4 Methods of measurement ................................................................................................................................. 14

5.4.1 Methods of measurement for transmitters .................................................................................................. 14

5.4.1.0 General provisions ................................................................................................................................ 14

5.4.1.1 Effective radiated power ....................................................................................................................... 14

5.4.1.2 TX emissions mask compliance measurement ...................................................................................... 15

5.4.2 Methods of measurement for receivers ....................................................................................................... 15

5.4.2.1 Receiver's unwanted emissions in the spurious domain ........................................................................ 15

5.4.2.2 Receiver blocking ................................................................................................................................. 16

5.4.2.2.0 Types of measurement ..................................................................................................................... 16

5.4.2.2.1 Radiated measurement ..................................................................................................................... 16

5.4.2.2.2 Conducted measurement.................................................................................................................. 16

5.4.2.2.3 Measurement procedure .................................................................................................................. 16

5.4.2.3 Receiver sensitivity ............................................................................................................................... 17

5.4.2.3.0 Types of measurement ..................................................................................................................... 17

5.4.2.3.1 Radiated measurement ..................................................................................................................... 17

5.4.2.3.2 Conducted measurement.................................................................................................................. 18

5.4.2.3.3 Measurement procedure .................................................................................................................. 18

5.4.2.4 Adjacent signal selectivity .................................................................................................................... 18

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

requirements of Directive 2014/53/EU ......................................................... 19

Annex B (normative): Human torso simulator ................................................................................. 20

B.1 General provisions .................................................................................................................................. 20

B.2 Human torso simulator for CCam radiated measurements ..................................................................... 20

Annex C (normative): Test site and antennas for radiated measurements..................................... 22

C.1 Test site description ................................................................................................................................ 22

C.2 Antennas ................................................................................................................................................. 23

C.2.1 Measurement antenna ....................................................................................................................................... 23

C.2.2 Substitution antenna ......................................................................................................................................... 23

C.3 Guidance on the use of radiation test site ............................................................................................... 23

C.3.0 General ............................................................................................................................................................. 23

C.3.1 Site preparation ................................................................................................................................................ 23

C.4 Radiated measurement methods for receivers ........................................................................................ 24

Annex D (informative): Change history ............................................................................................... 25

History .............................................................................................................................................................. 26

ETSI
---------------------- Page: 4 ----------------------
5 ETSI EN 303 520 V1.2.1 (2019-06)
Intellectual Property Rights
Essential patents

IPRs essential or potentially essential to normative deliverables may have been declared to ETSI. The information

pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found

in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in

respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web

server (https://ipr.etsi.org/).

Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee

can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web

server) which are, or may be, or may become, essential to the present document.
Trademarks

The present document may include trademarks and/or tradenames which are asserted and/or registered by their owners.

ETSI claims no ownership of these except for any which are indicated as being the property of ETSI, and conveys no

right to use or reproduce any trademark and/or tradename. Mention of those trademarks in the present document does

not constitute an endorsement by ETSI of products, services or organizations associated with those trademarks.

Foreword

This Harmonised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic

compatibility and Radio spectrum Matters (ERM).

The present document has been prepared under the Commission's standardisation request C(2015) 5376 final [i.1] 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.2].

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: 28 May 2019
Date of latest announcement of this EN (doa): 31 August 2019
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 29 February 2020
Date of withdrawal of any conflicting National Standard (dow): 28 February 2021
Modal verbs terminology

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

"cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of

provisions).

"must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation.

ETSI
---------------------- Page: 5 ----------------------
6 ETSI EN 303 520 V1.2.1 (2019-06)
Introduction

The present document is aiming to cover radio and telecommunications terminal equipment within the scope of the EU's

Radio Equipment Directive (RED) [i.2].

The present document specifies conformance requirements for the Ultra Low Power Wireless Medical Capsule

Endoscopy SRD application, which includes Capsule Camera (CCam) acting as transmitter and associated Data

Recorder (DR) receiver devices, as meant by ETSI TR 103 451 [i.3]. The CCam is designed to wirelessly transmit

recorded images from inside patient's gastrointestinal tract to the DR receiver, utilizing a single wideband radio channel

occupying the entire designated band 430 MHz to 440 MHz. It is intended that this band will be harmonised for

European-wide usage by Ultra Low Power Wireless Medical Endoscopy application through relevant CEPT and EU

normative documents in the field of SRD spectrum regulation, such as CEPT/ERC/REC 70-03 [i.4].

CCam transmitters will utilize miniature integral antenna encapsulated within its pill-shaped enclosure. The intended

use of the CCam transmitter is inside the human body.

DR receivers will use either integral antenna or dedicated external antenna implemented in the form of skin patch or

belt. Such dedicated external antenna would ensure optimal reception of weak radio signals by keeping antenna in direct

proximity to the patient's body in the area closest to internal passage of CCam.

These devices would offer opportunity of performing medical endoscopy-type examination of the entire human

gastrointestinal tract including the small intestine and colon. Thanks to simple application with minimized risks and side

effects, while providing the unique ability to visualize the complete gastrointestinal tract, its use would be highly

beneficial and attractive to patients and doctors.
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, symbols and abbreviations used.

• Clause 4 specifies the requirements and limits applicable to CCam transmitter and DR receiver.

• Clauses 5.1 and 5.2 specify the test and general conditions for testing of the equipment.

• Annex A (informative) provides an overview of the relationship between the present document and the

essential requirements of the RED [i.2].

• Annex B (normative) describes a human torso simulator test fixture to be used for radiated measurements.

• Annex C (normative) describes the Full Anechoic Room test site configuration for radiated measurements.

ETSI
---------------------- Page: 6 ----------------------
7 ETSI EN 303 520 V1.2.1 (2019-06)
1 Scope

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

Medical Capsule Endoscopy application (CCam transmitters and associated DR receivers) operating in the designated

frequency band 430 MHz to 440 MHz, as meant by ETSI TR 103 451 [i.3].

A possible return (downlink) RF transmission channel from DR to CCam for command and control signalling, if and

when implemented, is outside the scope of the present document.

NOTE: The relationship between the present document and essential requirements of article 3.2 of

Directive 2014/53/EU [i.2] is given in Annex A.
2 References
2.1 Normative references

References are specific, identified by date of publication and/or edition number or version number. Only the cited

version applies.

Referenced documents which are not found to be publicly available in the expected location might be found at

https://docbox.etsi.org/Reference/.

NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee

their long term validity.

The following referenced documents are necessary for the application of the present document.

Not applicable.
2.2 Informative references

References are either specific (identified by date of publication and/or edition number or version number) or

non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the

referenced document (including any amendments) applies.

NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee

their long term validity.

The following referenced documents are not necessary for the application of the present document but they assist the

user with regard to a particular subject area.

[i.1] Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation request

to the European Committee for Electrotechnical Standardisation and to the European

Telecommunications Standards Institute as regards radio equipment in support of Directive

2014/53/EU of the European Parliament and of the Council.

[i.2] Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the

harmonisation of the laws of the Member States relating to the making available on the market of

radio equipment and repealing Directive 1999/5/EC (RED).

[i.3] ETSI TR 103 451: "System Reference document (SRdoc); Short Range Devices (SRD); Technical

characteristics for UHF wideband Ultra Low Power Wireless Medical Capsule Endoscopy".

[i.4] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)".

[i.5] Body Tissue Dielectric Parameters provided by the Federal Communications Commission:

"Reference Calculation Tool".

NOTE: Available online at https://www.fcc.gov/general/body-tissue-dielectric-parameters.

ETSI
---------------------- Page: 7 ----------------------
8 ETSI EN 303 520 V1.2.1 (2019-06)

[i.6] Bioelectromagnetics (1987): "Simulated biological materials for electromagnetic radiation

absorption studies", Hartsgrove G., Kraszewski A. & Surowiec A. 8(1), 29-36.
3 Definition of terms, symbols and abbreviations
3.1 Terms
For the purposes of the present document, the following terms apply:

Capsule Camera (CCam): miniature disposable capsule-shaped optical imaging camera with integrated ultra low RF

power SRD transmitter, intended to be swallowed

Data Recorder (DR): device worn by the patient in order to record the stream of images received from CCam and store

NOTE: At the end of diagnostic procedure the stream of images may be downloaded to doctor's PC for

examination.

dedicated antenna: removable antenna supplied and tested with the radio equipment, designed as an indispensable part

of the equipment

integral antenna: permanent built-in antenna, designed as an indispensable part of the equipment

unwanted emissions in the spurious domain: components at any frequency, generated and radiated by active DR

receiver or CCam transmitter outside the defined operating frequency band of 430 MHz to 440 MHz

3.2 Symbols
For the purposes of the present document, the following symbols apply:
dB decibel
dBm absolute power level referred to one milliwatt
f frequency
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
CCam Capsule Camera
CEPT European Conference of Postal and Telecommunications administrations
DR Data Recorder
EC European Commission
EFTA European Free Trade Association
e.r.p. effective radiated power
EU European Union
EUT Equipment Under Test
FAR Fully Anechoic Room
RF Radio Frequency
RMS Root Mean Square
SRD Short Range Device
TX Transmitter
VSWR Voltage Standing Wave Ratio
ETSI
---------------------- Page: 8 ----------------------
9 ETSI EN 303 520 V1.2.1 (2019-06)
4 Technical requirements specifications
4.1 Environmental profile

Tests defined in the present document shall be carried out at representative points within the boundary limits of the

declared operational environmental profile.

Where technical performance varies subject to environmental conditions, tests shall be carried out under a sufficient

variety of environmental conditions (within the boundary limits of the declared operational environmental profile) to

give confidence of compliance for the affected technical requirements.
4.2 Conformance requirements
4.2.1 Transmitter requirements
4.2.1.1 Effective radiated power
4.2.1.1.1 Definition

The e.r.p. is the total power of CCam TX wanted emissions measured outside test patient's (phantom) body within the

designated band 430 MHz to 440 MHz, in the direction of the maximum radiated power under specified conditions of

measurements.
4.2.1.1.2 Limit

The e.r.p. of CCam TX shall not exceed -40 dBm/10 MHz total power, -50 dBm/100 kHz e.r.p. density within the

designated 430 MHz to 440 MHz band.
4.2.1.1.3 Conformance

The conformance tests for this requirement shall be as defined in clause 5.4.1.1 of the present document.

4.2.1.2 Transmitter emissions mask
4.2.1.2.1 Definition

The transmitter emissions mask envelope shall contain all constituent wanted and unwanted (including the unwanted

emissions in the spurious domain) RF emissions of CCam TX as measured outside test patient's (phantom) body in the

direction of maximum radiated power under specified conditions of measurements.
4.2.1.2.2 Limits
The transmitter emissions mask limits shall be as given in Figure 1.
ETSI
---------------------- Page: 9 ----------------------
10 ETSI EN 303 520 V1.2.1 (2019-06)
Power
density
-50 dBm/100 kHz (-40 dBm/10 MHz total power)
-60 dBm/100 kHz -60 dBm/100 kHz -50 dBm/1 MHz
-60 dBm/100 kHz
-66 dBm/100 kHz
30 402 405 430 440 1 000 3 000
f, MHz
Figure 1: CCam TX emissions mask (not to scale)

The power density limit given in this clause for in-channel portion of the mask is meant to constrain any small-scale

power density fluctuations across the transmission bandwidth and as such should not be compared directly or

bandwidth-converted to the aggregate e.r.p. limit for the entire useful signal given in the clause 4.2.1.1.2.

4.2.1.2.3 Conformance

The conformance tests for this requirement shall be as defined in clause 5.4.1.2 of the present docu

...

Draft ETSI EN 303 520 V1.1.2 (2019-02)
HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Ultra Low Power (ULP) wireless medical capsule endoscopy
devices operating in the band 430 MHz to 440 MHz;
Harmonised Standard for access to radio spectrum
---------------------- Page: 1 ----------------------
2 Draft ETSI EN 303 520 V1.1.2 (2019-02)
Reference
REN/ERM-TG30-321
Keywords
harmonised standard
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 prevailing version of an ETSI

deliverable is the one made publicly available in PDF format at www.etsi.org/deliver.

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 2019.
All rights reserved.
TM TM TM

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

TM TM

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

of the 3GPP Organizational Partners.

oneM2M™ logo is a trademark of ETSI registered for the benefit of its Members and

of the oneM2M Partners.
GSM and the GSM logo are trademarks registered and owned by the GSM Association.
ETSI
---------------------- Page: 2 ----------------------
3 Draft ETSI EN 303 520 V1.1.2 (2019-02)
Contents

Intellectual Property Rights ................................................................................................................................ 5

Foreword ............................................................................................................................................................. 5

Modal verbs terminology .................................................................................................................................... 5

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

1 Scope ........................................................................................................................................................ 7

2 References ................................................................................................................................................ 7

2.1 Normative references ......................................................................................................................................... 7

2.2 Informative references ........................................................................................................................................ 7

3 Definition of terms, symbols and abbreviations ....................................................................................... 8

3.1 Terms .................................................................................................................................................................. 8

3.2 Symbols .............................................................................................................................................................. 8

3.3 Abbreviations ..................................................................................................................................................... 8

4 Technical requirements specifications ..................................................................................................... 9

4.1 Environmental profile ......................................................................................................................................... 9

4.2 Conformance requirements ................................................................................................................................ 9

4.2.1 Transmitter requirements .............................................................................................................................. 9

4.2.1.1 Effective radiated power ......................................................................................................................... 9

4.2.1.1.1 Definition........................................................................................................................................... 9

4.2.1.1.2 Limit .................................................................................................................................................. 9

4.2.1.1.3 Conformance ..................................................................................................................................... 9

4.2.1.2 Transmitter emissions mask .................................................................................................................... 9

4.2.1.2.1 Definition........................................................................................................................................... 9

4.2.1.2.2 Limits ................................................................................................................................................ 9

4.2.1.2.3 Conformance ................................................................................................................................... 10

4.2.2 Receiver requirements ................................................................................................................................ 10

4.2.2.1 Unwanted Emissions in the Spurious Domain ...................................................................................... 10

4.2.2.1.1 Definition......................................................................................................................................... 10

4.2.2.1.2 Limit ................................................................................................................................................ 10

4.2.2.1.3 Conformance ................................................................................................................................... 10

4.2.2.2 Receiver blocking ................................................................................................................................. 10

4.2.2.2.1 Definition......................................................................................................................................... 10

4.2.2.2.2 Limits .............................................................................................................................................. 11

4.2.2.2.3 Conformance ................................................................................................................................... 11

4.2.2.3 Receiver sensitivity ............................................................................................................................... 11

4.2.2.3.1 Definition......................................................................................................................................... 11

4.2.2.3.2 Limit ................................................................................................................................................ 11

4.2.2.3.3 Conformance ................................................................................................................................... 11

4.2.2.4 Adjacent signal selectivity .................................................................................................................... 11

4.2.2.4.1 Definition......................................................................................................................................... 11

4.2.2.4.2 Limit ................................................................................................................................................ 11

4.2.2.4.3 Conformance ................................................................................................................................... 11

5 Testing for compliance with technical requirements .............................................................................. 12

5.1 Presentation of equipment for testing purposes ................................................................................................ 12

5.1.0 General provisions ...................................................................................................................................... 12

5.1.1 Choice of equipment model for testing ....................................................................................................... 12

5.1.2 Human torso simulator ................................................................................................................................ 12

5.1.3 Testing in external laboratory ..................................................................................................................... 12

5.2 Test conditions ................................................................................................................................................. 12

5.2.1 Test power source ....................................................................................................................................... 12

5.2.2 Temperature and humidity .......................................................................................................................... 13

5.2.3 Test signals and test modulation ................................................................................................................. 13

5.2.4 Antennas ..................................................................................................................................................... 13

5.2.5 Test fixture for CCam ................................................................................................................................. 13

ETSI
---------------------- Page: 3 ----------------------
4 Draft ETSI EN 303 520 V1.1.2 (2019-02)

5.2.6 Test site and general arrangements for radiated measurements .................................................................. 13

5.2.7 Measuring receiver ..................................................................................................................................... 13

5.3 Interpretation of the measurement results ........................................................................................................ 13

5.4 Methods of measurement ................................................................................................................................. 14

5.4.1 Methods of measurement for transmitters .................................................................................................. 14

5.4.1.0 General provisions ................................................................................................................................ 14

5.4.1.1 Effective radiated power ....................................................................................................................... 14

5.4.1.2 TX emissions mask compliance measurement ...................................................................................... 15

5.4.2 Methods of measurement for receivers ....................................................................................................... 16

5.4.2.1 Receiver's unwanted emissions in the spurious domain ........................................................................ 16

5.4.2.2 Receiver blocking ................................................................................................................................. 16

5.4.2.2.0 Types of measurement ..................................................................................................................... 16

5.4.2.2.1 Radiated measurement ..................................................................................................................... 16

5.4.2.2.2 Conducted measurement.................................................................................................................. 17

5.4.2.2.3 Measurement procedure .................................................................................................................. 17

5.4.2.3 Receiver sensitivity ............................................................................................................................... 18

5.4.2.3.0 Types of measurement ..................................................................................................................... 18

5.4.2.3.1 Radiated measurement ..................................................................................................................... 18

5.4.2.3.2 Conducted measurement.................................................................................................................. 18

5.4.2.3.3 Measurement procedure .................................................................................................................. 18

5.4.2.4 Adjacent signal selectivity .................................................................................................................... 19

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

requirements of Directive 2014/53/EU ......................................................... 20

Annex B (normative): Human torso simulator ................................................................................. 21

B.1 General provisions .................................................................................................................................. 21

B.2 Human torso simulator for CCam radiated measurements ..................................................................... 21

Annex C (normative): Test site and antennas for radiated measurements..................................... 23

C.1 Test site description ................................................................................................................................ 23

C.2 Antennas ................................................................................................................................................. 24

C.2.1 Measurement antenna ....................................................................................................................................... 24

C.2.2 Substitution antenna ......................................................................................................................................... 24

C.3 Guidance on the use of radiation test site ............................................................................................... 24

C.3.0 General ............................................................................................................................................................. 24

C.3.1 Site preparation ................................................................................................................................................ 24

C.4 Radiated measurement methods for receivers ........................................................................................ 25

Annex D (informative): Change history ............................................................................................... 26

History .............................................................................................................................................................. 27

ETSI
---------------------- Page: 4 ----------------------
5 Draft ETSI EN 303 520 V1.1.2 (2019-02)
Intellectual Property Rights
Essential patents

IPRs essential or potentially essential to normative deliverables may have been declared to ETSI. The information

pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found

in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in

respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web

server (https://ipr.etsi.org/).

Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee

can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web

server) which are, or may be, or may become, essential to the present document.
Trademarks

The present document may include trademarks and/or tradenames which are asserted and/or registered by their owners.

ETSI claims no ownership of these except for any which are indicated as being the property of ETSI, and conveys no

right to use or reproduce any trademark and/or tradename. Mention of those trademarks in the present document does

not constitute an endorsement by ETSI of products, services or organizations associated with those trademarks.

Foreword

This draft Harmonised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic

compatibility and Radio spectrum Matters (ERM), and is now submitted for the combined Public Enquiry and Vote

phase of the ETSI standards EN Approval Procedure.

The present document has been prepared under the Commission's standardisation request C(2015) 5376 final [i.1] 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.2].

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: 5 ----------------------
6 Draft ETSI EN 303 520 V1.1.2 (2019-02)
Introduction

The present document is aiming to cover radio and telecommunications terminal equipment within the scope of the EU's

Radio Equipment Directive (RED) [i.2].

The present document specifies conformance requirements for the Ultra Low Power Wireless Medical Capsule

Endoscopy SRD application, which includes Capsule Camera (CCam) acting as transmitter and associated Data

Recorder (DR) receiver devices, as meant by ETSI TR 103 451 [i.3]. The CCam is designed to wirelessly transmit

recorded images from inside patient's gastrointestinal tract to the DR receiver, utilizing a single wideband radio channel

occupying the entire designated band 430 MHz to 440 MHz. It is intended that this band will be harmonised for

European-wide usage by Ultra Low Power Wireless Medical Endoscopy application through relevant CEPT and EU

normative documents in the field of SRD spectrum regulation, such as CEPT/ERC/REC 70-03 [i.4].

CCam transmitters will utilize miniature integral antenna encapsulated within its pill-shaped enclosure. The intended

use of the CCam transmitter is inside the human body.

DR receivers will use either integral antenna or dedicated external antenna implemented in the form of skin patch or

belt. Such dedicated external antenna would ensure optimal reception of weak radio signals by keeping antenna in direct

proximity to the patient's body in the area closest to internal passage of CCam.

These devices would offer opportunity of performing medical endoscopy-type examination of the entire human

gastrointestinal tract including the small intestine and colon. Thanks to simple application with minimized risks and side

effects, while providing the unique ability to visualize the complete gastrointestinal tract, its use would be highly

beneficial and attractive to patients and doctors.
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, symbols and abbreviations used.

• Clause 4 specifies the requirements and limits applicable to CCam transmitter and DR receiver.

• Clauses 5.1 and 5.2 specify the test and general conditions for testing of the equipment.

• Clause 5.3 specifies the methods of measurement for the parameters specified in clause 4.

• Annex A (informative) provides an overview of the relationship between the present document and the

essential requirements of the RED [i.2].

• Annex B (normative) describes a human torso simulator test fixture to be used for radiated measurements.

• Annex C (normative) describes the Full Anechoic Room test site configuration for radiated measurements.

ETSI
---------------------- Page: 6 ----------------------
7 Draft ETSI EN 303 520 V1.1.2 (2019-02)
1 Scope

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

Medical Capsule Endoscopy application (CCam transmitters and associated DR receivers) operating in the designated

frequency band 430 MHz to 440 MHz, as meant by ETSI TR 103 451 [i.3].

A possible return (downlink) RF transmission channel from DR to CCam for command and control signalling, if and

when implemented, will be outside the scope of the present document.

NOTE: The relationship between the present document and essential requirements of article 3.2 of

Directive 2014/53/EU [i.2] is given in Annex A.
2 References
2.1 Normative references

References are specific, identified by date of publication and/or edition number or version number. Only the cited

version applies.

Referenced documents which are not found to be publicly available in the expected location might be found at

https://docbox.etsi.org/Reference/.

NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee

their long term validity.

The following referenced documents are necessary for the application of the present document.

Not applicable.
2.2 Informative references

References are either specific (identified by date of publication and/or edition number or version number) or

non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the

referenced document (including any amendments) applies.

NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee

their long term validity.

The following referenced documents are not necessary for the application of the present document but they assist the

user with regard to a particular subject area.

[i.1] Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation request

to the European Committee for Electrotechnical Standardisation and to the European

Telecommunications Standards Institute as regards radio equipment in support of Directive

2014/53/EU of the European Parliament and of the Council.

[i.2] Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the

harmonisation of the laws of the Member States relating to the making available on the market of

radio equipment and repealing Directive 1999/5/EC (RED).

[i.3] ETSI TR 103 451: "System Reference document (SRdoc); Short Range Devices (SRD); Technical

characteristics for UHF wideband Ultra Low Power Wireless Medical Capsule Endoscopy".

[i.4] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)".

[i.5] Body Tissue Dielectric Parameters provided by the Federal Communications Commission:

"Reference Calculation Tool".

NOTE: Available online at https://www.fcc.gov/general/body-tissue-dielectric-parameters.

ETSI
---------------------- Page: 7 ----------------------
8 Draft ETSI EN 303 520 V1.1.2 (2019-02)

[i.6] Bioelectromagnetics (1987): "Simulated biological materials for electromagnetic radiation

absorption studies", Hartsgrove G., Kraszewski A. & Surowiec A. 8(1), 29-36.
3 Definition of terms, symbols and abbreviations
3.1 Terms
For the purposes of the present document, the following terms apply:

Capsule Camera (CCam): miniature disposable capsule-shaped optical imaging camera with integrated ultra low RF

power SRD transmitter, intended to be swallowed

Data Recorder (DR): device worn by the patient in order to record the stream of images received from CCam and store

NOTE: At the end of diagnostic procedure the stream of images may be downloaded to doctor's PC for

examination.

dedicated antenna: removable antenna supplied and tested with the radio equipment, designed as an indispensable part

of the equipment

integral antenna: permanent built-in antenna, designed as an indispensable part of the equipment

unwanted emissions in the spurious domain: components at any frequency, generated and radiated by active DR

receiver or CCam transmitter outside the defined operating frequency band of 430 MHz to 440 MHz

3.2 Symbols
For the purposes of the present document, the following symbols apply:
dB decibel
dBm absolute power level referred to one milliwatt
f frequency
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
CCam Capsule Camera
CEPT European Conference of Postal and Telecommunications administrations
DR Data Recorder
EC European Commission
EFTA European Free Trade Association
EU European Union
EUT Equipment Under Test
FAR Fully Anechoic Room
RF Radio Frequency
RMS Root Mean Square
SRD Short Range Device
TX Transmitter
VSWR Voltage Standing Wave Ratio
ETSI
---------------------- Page: 8 ----------------------
9 Draft ETSI EN 303 520 V1.1.2 (2019-02)
4 Technical requirements specifications
4.1 Environmental profile

Tests defined in the present document shall be carried out at representative points within the boundary limits of the

declared operational environmental profile.

Where technical performance varies subject to environmental conditions, tests shall be carried out under a sufficient

variety of environmental conditions (within the boundary limits of the declared operational environmental profile) to

give confidence of compliance for the affected technical requirements.
4.2 Conformance requirements
4.2.1 Transmitter requirements
4.2.1.1 Effective radiated power
4.2.1.1.1 Definition

The effective radiated power is the total power of CCam TX wanted emissions measured outside test patient's

(phantom) body within the designated band 430 MHz to 440 MHz, in the direction of the maximum radiated power

under specified conditions of measurements.
4.2.1.1.2 Limit

The effective radiated power of CCam TX shall not exceed -40 dBm/10 MHz total power, -50 dBm/100 kHz e.r.p.

density within the designated 430 MHz to 440 MHz band.
4.2.1.1.3 Conformance

The conformance tests for this requirement shall be as defined in clause 5.4.1.1 of the present document.

4.2.1.2 Transmitter emissions mask
4.2.1.2.1 Definition

The transmitter emissions mask envelope shall contain all constituent wanted and unwanted (including the unwanted

emissions in the spurious domain) RF emissions of CCam TX as measured outside test patient's (phantom) body in the

direction of maximum radiated power under specified conditions of measurements.
4.2.1.2.2 Limits
The transmitter emissions mask limits shall be as given in Figure 1.
ETSI
---------------------- Page: 9 ----------------------
10 Draft ETSI EN 303 520 V1.1.2 (2019-02)
Power
density
-50 dBm/100 kHz (-40 dBm/10 MHz total power)
-60 dBm/100 kHz -60 dBm/100 kHz -50 dBm/1 MHz
-60 dBm/100 kHz
-66 dBm/100 kHz
30 402 405 430 440 1 000 3 000
F, MHz
Figure 1: CCam TX emissions mask (not to scale)

The power density limit given in this clause for in-channel portion of the mask is meant to constrain any small-scale

power density fluctuations across the transmission bandwidth and as such should
...

SLOVENSKI STANDARD
SIST EN 303 520 V1.2.1:2019
01-september-2019
Naprave kratkega dosega (SRD) - Medicinske naprave ultra male moči za
brezžično kapsulno endoskopijo, ki delujejo v pasu od 430 MHz do 440 MHz -
Harmonizirani standard za dostop do radijskega spektra
Short Range Devices (SRD) - Ultra Low Power (ULP) wireless medical capsule
endoscopy devices operating in the band 430 MHz to 440 MHz - Harmonised Standard
for access to radio spectrum
Ta slovenski standard je istoveten z: ETSI EN 303 520 V1.2.1 (2019-06)
ICS:
33.060.99 Druga oprema za radijske Other equipment for
komunikacije radiocommunications
SIST EN 303 520 V1.2.1:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 303 520 V1.2.1:2019
---------------------- Page: 2 ----------------------
SIST EN 303 520 V1.2.1:2019
ETSI EN 303 520 V1.2.1 (2019-06)
HARMONISED EUROPEAN STANDARD
Short Range Devices (SRD);
Ultra Low Power (ULP) wireless medical capsule endoscopy
devices operating in the band 430 MHz to 440 MHz;
Harmonised Standard for access to radio spectrum
---------------------- Page: 3 ----------------------
SIST EN 303 520 V1.2.1:2019
2 ETSI EN 303 520 V1.2.1 (2019-06)
Reference
REN/ERM-TG30-321
Keywords
harmonised standard
ETSI
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All rights reserved.

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

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of the oneM2M Partners.
GSM and the GSM logo are trademarks registered and owned by the GSM Association.
ETSI
---------------------- Page: 4 ----------------------
SIST EN 303 520 V1.2.1:2019
3 ETSI EN 303 520 V1.2.1 (2019-06)
Contents

Intellectual Property Rights ................................................................................................................................ 5

Foreword ............................................................................................................................................................. 5

Modal verbs terminology .................................................................................................................................... 5

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

1 Scope ........................................................................................................................................................ 7

2 References ................................................................................................................................................ 7

2.1 Normative references ......................................................................................................................................... 7

2.2 Informative references ........................................................................................................................................ 7

3 Definition of terms, symbols and abbreviations ....................................................................................... 8

3.1 Terms .................................................................................................................................................................. 8

3.2 Symbols .............................................................................................................................................................. 8

3.3 Abbreviations ..................................................................................................................................................... 8

4 Technical requirements specifications ..................................................................................................... 9

4.1 Environmental profile ......................................................................................................................................... 9

4.2 Conformance requirements ................................................................................................................................ 9

4.2.1 Transmitter requirements .............................................................................................................................. 9

4.2.1.1 Effective radiated power ......................................................................................................................... 9

4.2.1.1.1 Definition........................................................................................................................................... 9

4.2.1.1.2 Limit .................................................................................................................................................. 9

4.2.1.1.3 Conformance ..................................................................................................................................... 9

4.2.1.2 Transmitter emissions mask .................................................................................................................... 9

4.2.1.2.1 Definition........................................................................................................................................... 9

4.2.1.2.2 Limits ................................................................................................................................................ 9

4.2.1.2.3 Conformance ................................................................................................................................... 10

4.2.2 Receiver requirements ................................................................................................................................ 10

4.2.2.1 Unwanted Emissions in the Spurious Domain ...................................................................................... 10

4.2.2.1.1 Definition......................................................................................................................................... 10

4.2.2.1.2 Limit ................................................................................................................................................ 10

4.2.2.1.3 Conformance ................................................................................................................................... 10

4.2.2.2 Receiver blocking ................................................................................................................................. 10

4.2.2.2.1 Definition......................................................................................................................................... 10

4.2.2.2.2 Limits .............................................................................................................................................. 11

4.2.2.2.3 Conformance ................................................................................................................................... 11

4.2.2.3 Receiver sensitivity ............................................................................................................................... 11

4.2.2.3.1 Definition......................................................................................................................................... 11

4.2.2.3.2 Limit ................................................................................................................................................ 11

4.2.2.3.3 Conformance ................................................................................................................................... 11

4.2.2.4 Adjacent signal selectivity .................................................................................................................... 11

4.2.2.4.1 Definition......................................................................................................................................... 11

4.2.2.4.2 Limit ................................................................................................................................................ 11

4.2.2.4.3 Conformance ................................................................................................................................... 11

5 Testing for compliance with technical requirements .............................................................................. 12

5.1 Presentation of equipment for testing purposes ................................................................................................ 12

5.1.0 General provisions ...................................................................................................................................... 12

5.1.1 Choice of equipment model for testing ....................................................................................................... 12

5.1.2 Human torso simulator ................................................................................................................................ 12

5.1.3 Testing in external laboratory ..................................................................................................................... 12

5.2 Test conditions ................................................................................................................................................. 12

5.2.1 Test power source ....................................................................................................................................... 12

5.2.2 Temperature and humidity .......................................................................................................................... 13

5.2.3 Test signals and test modulation ................................................................................................................. 13

5.2.4 Antennas ..................................................................................................................................................... 13

5.2.5 Test fixture for CCam ................................................................................................................................. 13

ETSI
---------------------- Page: 5 ----------------------
SIST EN 303 520 V1.2.1:2019
4 ETSI EN 303 520 V1.2.1 (2019-06)

5.2.6 Test site and general arrangements for radiated measurements .................................................................. 13

5.2.7 Measuring receiver ..................................................................................................................................... 13

5.3 Void .................................................................................................................................................................. 13

5.4 Methods of measurement ................................................................................................................................. 14

5.4.1 Methods of measurement for transmitters .................................................................................................. 14

5.4.1.0 General provisions ................................................................................................................................ 14

5.4.1.1 Effective radiated power ....................................................................................................................... 14

5.4.1.2 TX emissions mask compliance measurement ...................................................................................... 15

5.4.2 Methods of measurement for receivers ....................................................................................................... 15

5.4.2.1 Receiver's unwanted emissions in the spurious domain ........................................................................ 15

5.4.2.2 Receiver blocking ................................................................................................................................. 16

5.4.2.2.0 Types of measurement ..................................................................................................................... 16

5.4.2.2.1 Radiated measurement ..................................................................................................................... 16

5.4.2.2.2 Conducted measurement.................................................................................................................. 16

5.4.2.2.3 Measurement procedure .................................................................................................................. 16

5.4.2.3 Receiver sensitivity ............................................................................................................................... 17

5.4.2.3.0 Types of measurement ..................................................................................................................... 17

5.4.2.3.1 Radiated measurement ..................................................................................................................... 17

5.4.2.3.2 Conducted measurement.................................................................................................................. 18

5.4.2.3.3 Measurement procedure .................................................................................................................. 18

5.4.2.4 Adjacent signal selectivity .................................................................................................................... 18

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

requirements of Directive 2014/53/EU ......................................................... 19

Annex B (normative): Human torso simulator ................................................................................. 20

B.1 General provisions .................................................................................................................................. 20

B.2 Human torso simulator for CCam radiated measurements ..................................................................... 20

Annex C (normative): Test site and antennas for radiated measurements..................................... 22

C.1 Test site description ................................................................................................................................ 22

C.2 Antennas ................................................................................................................................................. 23

C.2.1 Measurement antenna ....................................................................................................................................... 23

C.2.2 Substitution antenna ......................................................................................................................................... 23

C.3 Guidance on the use of radiation test site ............................................................................................... 23

C.3.0 General ............................................................................................................................................................. 23

C.3.1 Site preparation ................................................................................................................................................ 23

C.4 Radiated measurement methods for receivers ........................................................................................ 24

Annex D (informative): Change history ............................................................................................... 25

History .............................................................................................................................................................. 26

ETSI
---------------------- Page: 6 ----------------------
SIST EN 303 520 V1.2.1:2019
5 ETSI EN 303 520 V1.2.1 (2019-06)
Intellectual Property Rights
Essential patents

IPRs essential or potentially essential to normative deliverables may have been declared to ETSI. The information

pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found

in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in

respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web

server (https://ipr.etsi.org/).

Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee

can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web

server) which are, or may be, or may become, essential to the present document.
Trademarks

The present document may include trademarks and/or tradenames which are asserted and/or registered by their owners.

ETSI claims no ownership of these except for any which are indicated as being the property of ETSI, and conveys no

right to use or reproduce any trademark and/or tradename. Mention of those trademarks in the present document does

not constitute an endorsement by ETSI of products, services or organizations associated with those trademarks.

Foreword

This Harmonised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic

compatibility and Radio spectrum Matters (ERM).

The present document has been prepared under the Commission's standardisation request C(2015) 5376 final [i.1] 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.2].

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: 28 May 2019
Date of latest announcement of this EN (doa): 31 August 2019
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 29 February 2020
Date of withdrawal of any conflicting National Standard (dow): 28 February 2021
Modal verbs terminology

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

"cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of

provisions).

"must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation.

ETSI
---------------------- Page: 7 ----------------------
SIST EN 303 520 V1.2.1:2019
6 ETSI EN 303 520 V1.2.1 (2019-06)
Introduction

The present document is aiming to cover radio and telecommunications terminal equipment within the scope of the EU's

Radio Equipment Directive (RED) [i.2].

The present document specifies conformance requirements for the Ultra Low Power Wireless Medical Capsule

Endoscopy SRD application, which includes Capsule Camera (CCam) acting as transmitter and associated Data

Recorder (DR) receiver devices, as meant by ETSI TR 103 451 [i.3]. The CCam is designed to wirelessly transmit

recorded images from inside patient's gastrointestinal tract to the DR receiver, utilizing a single wideband radio channel

occupying the entire designated band 430 MHz to 440 MHz. It is intended that this band will be harmonised for

European-wide usage by Ultra Low Power Wireless Medical Endoscopy application through relevant CEPT and EU

normative documents in the field of SRD spectrum regulation, such as CEPT/ERC/REC 70-03 [i.4].

CCam transmitters will utilize miniature integral antenna encapsulated within its pill-shaped enclosure. The intended

use of the CCam transmitter is inside the human body.

DR receivers will use either integral antenna or dedicated external antenna implemented in the form of skin patch or

belt. Such dedicated external antenna would ensure optimal reception of weak radio signals by keeping antenna in direct

proximity to the patient's body in the area closest to internal passage of CCam.

These devices would offer opportunity of performing medical endoscopy-type examination of the entire human

gastrointestinal tract including the small intestine and colon. Thanks to simple application with minimized risks and side

effects, while providing the unique ability to visualize the complete gastrointestinal tract, its use would be highly

beneficial and attractive to patients and doctors.
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, symbols and abbreviations used.

• Clause 4 specifies the requirements and limits applicable to CCam transmitter and DR receiver.

• Clauses 5.1 and 5.2 specify the test and general conditions for testing of the equipment.

• Annex A (informative) provides an overview of the relationship between the present document and the

essential requirements of the RED [i.2].

• Annex B (normative) describes a human torso simulator test fixture to be used for radiated measurements.

• Annex C (normative) describes the Full Anechoic Room test site configuration for radiated measurements.

ETSI
---------------------- Page: 8 ----------------------
SIST EN 303 520 V1.2.1:2019
7 ETSI EN 303 520 V1.2.1 (2019-06)
1 Scope

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

Medical Capsule Endoscopy application (CCam transmitters and associated DR receivers) operating in the designated

frequency band 430 MHz to 440 MHz, as meant by ETSI TR 103 451 [i.3].

A possible return (downlink) RF transmission channel from DR to CCam for command and control signalling, if and

when implemented, is outside the scope of the present document.

NOTE: The relationship between the present document and essential requirements of article 3.2 of

Directive 2014/53/EU [i.2] is given in Annex A.
2 References
2.1 Normative references

References are specific, identified by date of publication and/or edition number or version number. Only the cited

version applies.

Referenced documents which are not found to be publicly available in the expected location might be found at

https://docbox.etsi.org/Reference/.

NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee

their long term validity.

The following referenced documents are necessary for the application of the present document.

Not applicable.
2.2 Informative references

References are either specific (identified by date of publication and/or edition number or version number) or

non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the

referenced document (including any amendments) applies.

NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee

their long term validity.

The following referenced documents are not necessary for the application of the present document but they assist the

user with regard to a particular subject area.

[i.1] Commission Implementing Decision C(2015) 5376 final of 4.8.2015 on a standardisation request

to the European Committee for Electrotechnical Standardisation and to the European

Telecommunications Standards Institute as regards radio equipment in support of Directive

2014/53/EU of the European Parliament and of the Council.

[i.2] Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the

harmonisation of the laws of the Member States relating to the making available on the market of

radio equipment and repealing Directive 1999/5/EC (RED).

[i.3] ETSI TR 103 451: "System Reference document (SRdoc); Short Range Devices (SRD); Technical

characteristics for UHF wideband Ultra Low Power Wireless Medical Capsule Endoscopy".

[i.4] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)".

[i.5] Body Tissue Dielectric Parameters provided by the Federal Communications Commission:

"Reference Calculation Tool".

NOTE: Available online at https://www.fcc.gov/general/body-tissue-dielectric-parameters.

ETSI
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SIST EN 303 520 V1.2.1:2019
8 ETSI EN 303 520 V1.2.1 (2019-06)

[i.6] Bioelectromagnetics (1987): "Simulated biological materials for electromagnetic radiation

absorption studies", Hartsgrove G., Kraszewski A. & Surowiec A. 8(1), 29-36.
3 Definition of terms, symbols and abbreviations
3.1 Terms
For the purposes of the present document, the following terms apply:

Capsule Camera (CCam): miniature disposable capsule-shaped optical imaging camera with integrated ultra low RF

power SRD transmitter, intended to be swallowed

Data Recorder (DR): device worn by the patient in order to record the stream of images received from CCam and store

NOTE: At the end of diagnostic procedure the stream of images may be downloaded to doctor's PC for

examination.

dedicated antenna: removable antenna supplied and tested with the radio equipment, designed as an indispensable part

of the equipment

integral antenna: permanent built-in antenna, designed as an indispensable part of the equipment

unwanted emissions in the spurious domain: components at any frequency, generated and radiated by active DR

receiver or CCam transmitter outside the defined operating frequency band of 430 MHz to 440 MHz

3.2 Symbols
For the purposes of the present document, the following symbols apply:
dB decibel
dBm absolute power level referred to one milliwatt
f frequency
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
CCam Capsule Camera
CEPT European Conference of Postal and Telecommunications administrations
DR Data Recorder
EC European Commission
EFTA European Free Trade Association
e.r.p. effective radiated power
EU European Union
EUT Equipment Under Test
FAR Fully Anechoic Room
RF Radio Frequency
RMS Root Mean Square
SRD Short Range Device
TX Transmitter
VSWR Voltage Standing Wave Ratio
ETSI
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SIST EN 303 520 V1.2.1:2019
9 ETSI EN 303 520 V1.2.1 (2019-06)
4 Technical requirements specifications
4.1 Environmental profile

Tests defined in the present document shall be carried out at representative points within the boundary limits of the

declared operational environmental profile.

Where technical performance varies subject to environmental conditions, tests shall be carried out under a sufficient

variety of environmental conditions (within the boundary limits of the declared operational environmental profile) to

give confidence of compliance for the affected technical requirements.
4.2 Conformance requirements
4.2.1 Transmitter requirements
4.2.1.1 Effective radiated power
4.2.1.1.1 Definition

The e.r.p. is the total power of CCam TX wanted emissions measured outside test patient's (phantom) body within the

designated band 430 MHz to 440 MHz, in the direction of the maximum radiated power under specified conditions of

measurements.
4.2.1.1.2 Limit

The e.r.p. of CCam TX shall not exceed -40 dBm/10 MHz total power, -50 dBm/100 kHz e.r.p. density within the

designated 430 MHz to 440 MHz band.
4.2.1.1.3 Conformance

The conformance tests for this requirement shall be as defined in clause 5.4.1.1 of the present document.

4.2.1.2 Transmitter emissions mask
4.2.1.2.1 Definition
...

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