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STANDARD
SIST EN 303 520 V1.1.1:2018
ETSI EN 303 520 V1.1.1 (2018-07) 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
HARMONISED EUROPEAN STANDARD SIST EN 303 520 V1.1.1:2018
ETSI ETSI EN 303 520 V1.1.1 (2018-07) 2
Reference DEN/ERM-TG30-315 Keywords harmonised standard ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
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ETSI ETSI EN 303 520 V1.1.1 (2018-07) 3 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 Definitions, symbols and abbreviations . 8 3.1 Definitions . 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 SIST EN 303 520 V1.1.1:2018
ETSI ETSI EN 303 520 V1.1.1 (2018-07) 4 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
SIST EN 303 520 V1.1.1:2018
ETSI ETSI EN 303 520 V1.1.1 (2018-07) 5 Intellectual Property Rights Essential patents
IPRs essential or potentially essential to normative deliverables may have been declared to ETSI. The information pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web server (https://ipr.etsi.org/). Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web server) which are, or may be, or may become, essential to the present document. Trademarks The present document may include trademarks and/or tradenames which are asserted and/or registered by their owners. ETSI claims no ownership of these except for any which are indicated as being the property of ETSI, and conveys no right to use or reproduce any trademark and/or tradename. Mention of those trademarks in the present document does not constitute an endorsement by ETSI of products, services or organizations associated with those trademarks. Foreword This Harmonised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document has been prepared under the Commission's standardisation request C(2015) 5376 final [i.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: 17 July 2018 Date of latest announcement of this EN (doa): 31 October 2018 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
30 April 2019 Date of withdrawal of any conflicting National Standard (dow): 30 April 2020
Modal verbs terminology In the present document "shall", "shall not", "should", "should not", "may", "need not", "will", "will not", "can" and "cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of provisions). "must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation. SIST EN 303 520 V1.1.1:2018
ETSI ETSI EN 303 520 V1.1.1 (2018-07) 6 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.
SIST EN 303 520 V1.1.1:2018
ETSI ETSI EN 303 520 V1.1.1 (2018-07) 7 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. Reference Calculation Tool provided by the Federal Communications Commission. NOTE: Available online at: https://www.fcc.gov/general/body-tissue-dielectric-parameters. SIST EN 303 520 V1.1.1:2018
ETSI ETSI EN 303 520 V1.1.1 (2018-07) 8 [i.6] Hartsgrove, G., Kraszewski, A. & Surowiec, A. (1987): "Simulated biological materials for electromagnetic radiation absorption studies". Bioelectromagnetics, 8(1), 29-36. 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the following terms and definitions 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 it 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 SIST EN 303 520 V1.1.1:2018
ETSI ETSI EN 303 520 V1.1.1 (2018-07) 9 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. SIST EN 303 520 V1.1.1:2018
ETSI ETSI EN 303 520 V1.1.1 (2018-07) 10
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 effective radiated power 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 document. 4.2.2 Receiver requirements 4.2.2.1 Unwanted Emissions in the Spurious Domain 4.2.2.1.1 Definition
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