ETSI EN 303 520-2018 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 acc.pdf

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1、 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 ETSI ETSI EN 303 520 V1.1.1 (2018-07) 2 Reference DEN/

2、ERM-TG30-315 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 but non lucratif enregistre la Sous-Prfecture de Grasse (06) N 7803/88 Important notice The p

3、resent 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

4、ETSI. In case of any existing or perceived difference in contents between such versions and/or in print, the only prevailing document is the print of the Portable Document Format (PDF) version kept on a specific network drive within ETSI Secretariat. Users of the present document should be aware tha

5、t 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

6、: 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

7、not be modified without the written authorization of ETSI. The copyright and the foregoing restriction extend to reproduction in all media. ETSI 2018. All rights reserved. DECTTM, PLUGTESTSTM, UMTSTMand the ETSI logo are trademarks of ETSI registered for the benefit of its Members. 3GPPTM and LTETMa

8、re trademarks of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. oneM2M logo is protected for the benefit of its Members. GSMand the GSM logo are trademarks registered and owned by the GSM Association. ETSI ETSI EN 303 520 V1.1.1 (2018-07) 3 Contents Intellect

9、ual Property Rights 5g3Foreword . 5g3Modal verbs terminology 5g3Introduction 6g31 Scope 7g32 References 7g32.1 Normative references . 7g32.2 Informative references 7g33 Definitions, symbols and abbreviations . 8g33.1 Definitions 8g33.2 Symbols 8g33.3 Abbreviations . 8g34 Technical requirements speci

10、fications . 9g34.1 Environmental profile . 9g34.2 Conformance requirements 9g34.2.1 Transmitter requirements 9g34.2.1.1 Effective radiated power . 9g34.2.1.1.1 Definition. 9g34.2.1.1.2 Limit 9g34.2.1.1.3 Conformance . 9g34.2.1.2 Transmitter emissions mask 9g34.2.1.2.1 Definition. 9g34.2.1.2.2 Limits

11、 9g34.2.1.2.3 Conformance . 10g34.2.2 Receiver requirements 10g34.2.2.1 Unwanted Emissions in the Spurious Domain 10g34.2.2.1.1 Definition. 10g34.2.2.1.2 Limit 10g34.2.2.1.3 Conformance . 10g34.2.2.2 Receiver blocking . 10g34.2.2.2.1 Definition. 10g34.2.2.2.2 Limits 11g34.2.2.2.3 Conformance . 11g34

12、.2.2.3 Receiver sensitivity . 11g34.2.2.3.1 Definition. 11g34.2.2.3.2 Limit 11g34.2.2.3.3 Conformance . 11g34.2.2.4 Adjacent signal selectivity 11g34.2.2.4.1 Definition. 11g34.2.2.4.2 Limit 11g34.2.2.4.3 Conformance . 11g35 Testing for compliance with technical requirements 12g35.1 Presentation of e

13、quipment for testing purposes 12g35.1.0 General provisions 12g35.1.1 Choice of equipment model for testing . 12g35.1.2 Human torso simulator 12g35.1.3 Testing in external laboratory . 12g35.2 Test conditions . 12g35.2.1 Test power source . 12g35.2.2 Temperature and humidity 13g35.2.3 Test signals an

14、d test modulation . 13g35.2.4 Antennas . 13g35.2.5 Test fixture for CCam . 13g3ETSI ETSI EN 303 520 V1.1.1 (2018-07) 4 5.2.6 Test site and general arrangements for radiated measurements 13g35.2.7 Measuring receiver . 13g35.3 Interpretation of the measurement results 13g35.4 Methods of measurement .

15、14g35.4.1 Methods of measurement for transmitters 14g35.4.1.0 General provisions 14g35.4.1.1 Effective radiated power . 14g35.4.1.2 TX emissions mask compliance measurement 15g35.4.2 Methods of measurement for receivers . 16g35.4.2.1 Receivers unwanted emissions in the spurious domain 16g35.4.2.2 Re

16、ceiver blocking . 16g35.4.2.2.0 Types of measurement . 16g35.4.2.2.1 Radiated measurement. 16g35.4.2.2.2 Conducted measurement 17g35.4.2.2.3 Measurement procedure 17g35.4.2.3 Receiver sensitivity . 18g35.4.2.3.0 Types of measurement . 18g35.4.2.3.1 Radiated measurement. 18g35.4.2.3.2 Conducted measu

17、rement 18g35.4.2.3.3 Measurement procedure 18g35.4.2.4 Adjacent signal selectivity 19g3Annex A (informative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 20g3Annex B (normative): Human torso simulator . 21g3B.1 General provisions 21g3B.2 Human t

18、orso simulator for CCam radiated measurements . 21g3Annex C (normative): Test site and antennas for radiated measurements. 23g3C.1 Test site description 23g3C.2 Antennas . 24g3C.2.1 Measurement antenna . 24g3C.2.2 Substitution antenna . 24g3C.3 Guidance on the use of radiation test site . 24g3C.3.0

19、General . 24g3C.3.1 Site preparation 24g3C.4 Radiated measurement methods for receivers 25g3Annex D (informative): Change history . 26g3History 27g3ETSI ETSI EN 303 520 V1.1.1 (2018-07) 5 Intellectual Property Rights Essential patents IPRs essential or potentially essential to normative deliverables

20、 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 ETS

21、I 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

22、 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 o

23、f 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 tho

24、se 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 Commissions standardisation request C(2015) 5376 final i.1 to provide one volu

25、ntary 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

26、 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

27、 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 Stand

28、ard (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)

29、. “must“ and “must not“ are NOT allowed in ETSI deliverables except when used in direct citation. 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 EUs Radio Equipment Directive (RED) i

30、.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

31、 to wirelessly transmit recorded images from inside patients 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 Wirel

32、ess 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 transmitte

33、r 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 patients body in t

34、he 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

35、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 a

36、nd 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 th

37、e 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)

38、describes the Full Anechoic Room test site configuration for radiated measurements. 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 transmitte

39、rs 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 d

40、ocument. 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 c

41、ited 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 validi

42、ty. 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 c

43、ited 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 docu

44、ments 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 t

45、o 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 St

46、ates 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

47、/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. ETSI ETSI EN 303 520 V1.1.

48、1 (2018-07) 8 i.6 Hartsgrove, G., Kraszewski, A. to establish the appropriate test conditions. Additionally, technical documentation and operating manuals, sufficient to make the tests, shall be supplied. The physical arrangements used for the testing shall be fully documented in the test report. 5.

49、1.1 Choice of equipment model for testing One sample (or more when necessary for completion of prolonged/repetitive tests, such as when it is impossible to replace battery in a disposable CCam EUT) of each model or type of CCam transmitter and DR receiver shall be used for testing. Any ancillary equipment used for testing including any technical means employed for suitable activation and control of equipment functions during measurement shall be described in the test report. If an equipment has several optional features, consider