SIST EN 303 520 V1.2.1:2019

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.

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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

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

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

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

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

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

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

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

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

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

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

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

• 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

• 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.

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

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

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

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

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

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

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

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

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

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

[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

[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

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

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

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

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

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

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

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

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

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

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

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

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