SIST EN 302 537 V2.1.1:2016
(Main)Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
The present document applies to ultra low power systems and accessories operating in spectrum within the bands
401 MHz to 402 MHz and 405 MHz to 406 MHz that operate in a MEDS service for telecommand and telemetry
between devices that are part of a MEDS (see definition of MEDS);
Only two types of MEDS system devices are permitted under the present document:
1) Frequency agile devices designed to access a minimum of 18 channels evenly distributed across the 401 MHz
to 402 MHz and 405 MHz to 406 MHz bands with a minimum of 9 channels for each 1 MHz segment (i.e.
401 MHz to 402 MHz and 405 MHz to 406 MHz).
2) Devices capable of operation only on a single channel using low duty cycle and low power for spectrum access
in the 401 MHz to 402 MHz or 405 MHz to 406 MHz bands, see clause 4.2.3.1.2 and the following clauses.
The frequency usage conditions for the bands 401 MHz to 402 MHz and 405 MHz to 406 MHz are European wide
harmonised for "active medical implant devices" according to Commission Implementing Decision 2013/752/EU [i.12]
and ERC Decision (01)17 [i.1] with the following usage restrictions:
• "This set of usage conditions is only available for systems specifically designed for the purpose of providing
non-voice digital communications between active implantable medical devices and/or body-worn devices and
other devices external to the human body used for transferring non-time critical individual patient-related
physiological information."
The present document covers devices utilizing ultra low power radio devices in combination with medical devices, the
medical portion of which is regulated by the Medical Device Directive [i.8] (MDD) or the Active Implantable Medical
Device Directive (AIMD [i.9]). The radio part of medical devices regulated by the MDD is hereafter referred to as
ULP-AMD, ULP-AMD-P for peripheral devices, and ULP-BWD for body worn devices. ULP-BWD are devices, such
as a physiological parameter sensor or handheld devices that are intended to operate in very close proximity to the
human body, including touching the body, whose radio antenna is external to the body and is used to communicate with
a device that is part of a MEDS system. The radio part of medical devices regulated under the AIMD is hereafter
referred to as Ultra Low Power-Active Medical Implants (ULP-AMI) and peripherals (ULP-AMI-P) used in a Medical
Data Service (MEDS).
Devices covered by the present document are an evolving new technology to be made available worldwide by the
medical equipment industry that will provide high speed communications capability between devices associated with an
individual patient that are part of a complete MEDS system as defined in clause 3.1. Examples of MEDS devices falling
under the scope of the present document are portable body worn physiological sensors that allow ambulatory
monitoring, implanted devices and external system devices used to transfer data collected by a MEDS system to
medical practitioners that will use the data to diagnose and treat a patient.
The present document contains requirements to demonstrate that Ultra Low Power Medical Data Service (MEDS)
Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz "… shall be so constructed
that they both effectively use and support the efficient use of radio spectrum in order to avoid harmful interference"
(article 3.2 of the Directive 2014/53/EU [i.2]). It does not necessarily include all the characteristics, which may be
required by a user, nor does it necessarily represent the optimum performance achievable.
Službeni sistemi ultra majhnih moči za medicinske podatke (MEDS), ki delujejo v frekvenčnih območjih od 401 MHz do 402 MHz in od 405 MHz do 406 MHz - Harmonizirani standard, ki zajema bistvene zahteve člena 3.2 direktive 2014/53/EU
Ta dokument se uporablja za službene sisteme ultra majhnih moči in dodatno opremo, ki delujejo v pasovih spektra od 401 MHz do 402 MHz in od 405 MHz do 406 MHz v službenih sistemih ultra majhnih moči za medicinske podatke (MEDS), za daljinsko vodenje in telemetrijo med napravami, ki so del službenih sistemov ultra majhnih moči za medicinske podatke (glej razlago službenega sistema ultra majhnih moči za medicinske podatke).
Ta dokument dovoljuje le dve vrsti naprav s službenim sistemom ultra majhnih moči za medicinske podatke:
1) Naprave s frekvenčno agilnostjo, zasnovane za dostop do najmanj 18 kanalov, ki so enakomerno porazdeljeni po pasovih od 401 MHz do 402 MHz in od 405 MHz do 406 MHz, z najmanj 9 kanali za vsak segment po 1 MHz (tj. od 401 MHz do 402 MHz in od 405 MHz do 406 MHz).
2) Naprave, ki lahko delujejo le na enem kanalu in za dostop do pasov spektra od 401 MHz do 402 MHz ali od 405 MHz do 406 MHz uporabljajo nizek obratovalni cikel in nizko porabo – glej točko 4.2.3.1.2 in naslednje točke.
Pogoji uporabe frekvenc za pasove od 401 MHz do 402 MHz in od 405 MHz do 406 MHz so v skladu z izvedbenim sklepom Komisije 2013/752/EU [i.12] in odločbo ERC (01)17 [i.1] v celotni Evropski uniji usklajeni za »aktivne medicinske pripomočke za vsaditev« z naslednjimi omejitvami uporabe:
• »Ta niz pogojev uporabe je na voljo le za sisteme, ki so posebej zasnovani za zagotavljanje negovorne digitalne komunikacije med aktivnimi medicinskimi napravami za vsaditev in/ali napravami, ki jih nosi oseba na telesu, ter drugimi napravami izven človeškega telesa, ki se uporabljajo za prenos časovno nekritičnih fizioloških podatkov o bolniku.«
Ta dokument zajema naprave, ki uporabljajo radijske naprave ultra majhnih moči v kombinaciji z medicinskimi pripomočki, pri čemer medicinski del ureja direktiva o medicinskih pripomočkih [i.8] oz. direktiva o aktivnih medicinskih pripomočkih za vsaditev [i.9]. Radijski del medicinskih pripomočkov, ki ga ureja direktiva o medicinskih pripomočkih, je v nadaljevanju imenovan »aktivni medicinski pripomočki ultra majhnih moči«, »pripadajoče periferne naprave« in »naprave ultra majhnih moči, ki jih nosi oseba na telesu«. Naprave ultra majhnih moči, ki jih nosi oseba na telesu, so naprave, kot je senzor fizioloških parametrov, ali ročne naprave, ki so namenjene za uporabo v neposredni bližini človeškega telesa, vključno z dotikanjem telesa, katerih radijska antena je zunaj telesa in se uporablja za komunikacijo z napravo, ki je del službenega sistema ultra majhnih moči za medicinske podatke. Radijski del medicinskih pripomočkov, ki ga ureja direktiva o aktivnih medicinskih pripomočkih za vsaditev, je v nadaljevanju imenovan »aktivni medicinski vsadki ultra majhnih moči« in »pripadajoče periferne naprave«, ki se uporabljajo v službenem sistemu ultra majhnih moči za medicinske podatke.
Naprave, obravnavane v tem dokumentu, so razvijajoča se nova tehnologija, uporabo katere bodo proizvajalci medicinske opreme omogočili po vsem svetu in ki bo zagotavljala hitro komunikacijo med napravami, ki so povezane z določenim bolnikom in so del celostnega službenega sistema ultra majhnih moči za medicinske podatke, kot je opredeljeno v točki 3.1. Primeri naprav za službene sisteme ultra majhnih moči za medicinske podatke, ki so zajeti v tem dokumentu, so prenosni fiziološki senzorji, ki jih nosi oseba na telesu in omogočajo spremljanje zdravstvenega stanja, vsajene naprave in zunanje sistemske naprave, ki se uporabljajo za prenos podatkov, zbranih prek službenega sistema ultra majhnih moči za medicinske podatke, do zdravnikov, ki bodo podatke uporabili za postavitev diagnoze in zdravljenje bolnika.
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz - Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU33.060.99Druga oprema za radijske komunikacijeOther equipment for radiocommunicationsICS:Ta slovenski standard je istoveten z:ETSI EN 302 537 V2.1.1 (2016-10)SIST EN 302 537 V2.1.1:2016en01-december-2016SIST EN 302 537 V2.1.1:2016SLOVENSKI
STANDARD
SIST EN 302 537 V2.1.1:2016
ETSI EN 302 537 V2.1.1 (2016-10) Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
HARMONISED EUROPEAN STANDARD SIST EN 302 537 V2.1.1:2016
ETSI ETSI EN 302 537 V2.1.1 (2016-10) 2
Reference REN/ERM-TG30-307 Keywords harmonised standard, radio, regulation, testing ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
Tel.: +33 4 92 94 42 00
Fax: +33 4 93 65 47 16
Siret N° 348 623 562 00017 - NAF 742 C Association à but non lucratif enregistrée à la Sous-Préfecture de Grasse (06) N° 7803/88
Important notice The present document can be downloaded from: http://www.etsi.org/standards-search The present document may be made available in electronic versions and/or in print. The content of any electronic and/or print versions of the present document shall not be modified without the prior written authorization of ETSI. In case of any existing or perceived difference in contents between such versions and/or in print, the only prevailing document is the print of the Portable Document Format (PDF) version kept on a specific network drive within ETSI Secretariat. Users of the present document should be aware that the document may be subject to revision or change of status. Information on the current status of this and other ETSI documents is available at https://portal.etsi.org/TB/ETSIDeliverableStatus.aspx If you find errors in the present document, please send your comment to one of the following services: https://portal.etsi.org/People/CommiteeSupportStaff.aspx Copyright Notification No part may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm except as authorized by written permission of ETSI. The content of the PDF version shall not be modified without the written authorization of ETSI. The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2016. All rights reserved.
DECTTM, PLUGTESTSTM, UMTSTM and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members. 3GPPTM and LTE™ are Trade Marks of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association. SIST EN 302 537 V2.1.1:2016
ETSI ETSI EN 302 537 V2.1.1 (2016-10) 3 Contents Intellectual Property Rights . 6 Foreword . 6 Modal verbs terminology . 6 Introduction . 6 1 Scope . 8 2 References . 9 2.1 Normative references . 9 2.2 Informative references . 9 3 Definitions, symbols and abbreviations . 10 3.1 Definitions . 10 3.2 Symbols . 12 3.3 Abbreviations . 13 4 Technical requirements specifications . 14 4.1 Environmental profile . 14 4.2 Conformance requirements . 14 4.2.1 Transmitter requirements . 14 4.2.1.1 Frequency error . 14 4.2.1.1.1 Definition. 14 4.2.1.1.2 Limits . 14 4.2.1.1.3 Conformance . 14 4.2.1.2 Emission bandwidth . 14 4.2.1.2.1 Definition. 14 4.2.1.2.2 Limits . 14 4.2.1.2.3 Conformance . 14 4.2.1.3 Effective radiated power of the fundamental emission . 15 4.2.1.3.0 General requirement . 15 4.2.1.3.1 Definition. 15 4.2.1.3.2 Limits . 15 4.2.1.3.3 Conformance . 15 4.2.1.4 Spurious emissions of transmitter . 15 4.2.1.4.0 General requirement . 15 4.2.1.4.1 Definition. 16 4.2.1.4.2 Limits . 16 4.2.1.4.3 Conformance . 16 4.2.1.5 Frequency stability under low voltage conditions . 16 4.2.1.5.1 Definition. 16 4.2.1.5.2 Limits . 16 4.2.1.5.3 Conformance . 16 4.2.2 Receiver requirements . 17 4.2.2.1 Spurious radiation of receivers . 17 4.2.2.1.1 Definition. 17 4.2.2.1.2 Limits . 17 4.2.2.1.3 Conformance . 17 4.2.2.2 Receiver blocking . 17 4.2.2.2.1 Definition. 17 4.2.2.2.2 Limits . 17 4.2.2.2.3 Conformance . 17 4.2.3 Transmitter and Receiver requirements . 17 4.2.3.1 Spectrum Access . 17 4.2.3.1.0 General requirements . 17 4.2.3.1.1 LBT/AFA spectrum access . 18 4.2.3.1.2 Low Power Low Duty Cycle spectrum access . 19 4.3 Mechanical and electrical design . 19 4.3.1 General . 19 SIST EN 302 537 V2.1.1:2016
ETSI ETSI EN 302 537 V2.1.1 (2016-10) 4 4.3.2 Antennas . 19 4.3.3 Controls . 19 4.3.4 Transmitter shut-off facility . 19 4.3.5 Void . 20 4.3.6 Equipment identification . 20 5 Testing for compliance with technical requirements . 20 5.1 Environmental conditions for testing . 20 5.1.0 General remark . 20 5.1.1 Presentation of equipment for testing purposes . 20 5.1.1.0 General remark . 20 5.1.1.1 Choice of model for testing . 20 5.1.1.2 Testing of equipment with alternative power levels . 21 5.1.1.3 Testing of equipment that does not have an external 50 Ω RF connector (integral antenna equipment) . 21 5.1.1.3.1 Equipment with an internal permanent or temporary antenna connector . 21 5.1.1.3.2 Equipment with a temporary antenna connector . 21 5.1.1.3.3 Equipment intended to be implanted in or worn on but totally external to a human body . 21 5.1.2 Declarations by the provider . 21 5.1.3 Auxiliary test equipment . 21 5.1.4 Test Conditions . 21 5.1.4.1 Normal and extreme test conditions . 21 5.1.4.2 Test power source . 22 5.1.4.2.0 General remark . 22 5.1.4.2.1 External test power source . 22 5.1.4.2.2 Internal test power source . 22 5.1.4.3 Normal test conditions . 22 5.1.4.3.1 Normal temperature and humidity . 22 5.1.4.3.2 Normal test power source . 23 5.1.4.4 Extreme test conditions . 23 5.1.4.4.1 Extreme temperatures . 23 5.1.4.4.2 Extreme test source voltages . 24 5.1.4.5 Normal test signals and test modulation. 25 5.1.4.5.0 General remark . 25 5.1.4.5.1 Normal modulation test signals for data . 25 5.1.4.6 Antennas . 26 5.1.4.6.0 General remark . 26 5.1.4.6.1 Artificial antenna . 26 5.1.4.6.2 Artificial antenna for transmitters with 50 Ω impedance connector . 26 5.1.4.7 Test fixture for ULP-AMD, ULP-AMD-P and ULP-AMI-P devices . 26 5.1.4.8 Test fixture for ULP-AMI and ULP-BWD . 27 5.1.4.9 Test sites and general arrangements for radiated measurements . 27 5.1.4.10 Modes of operation of the transmitter . 27 5.1.4.11 Measuring receiver . 27 5.2 Interpretation of the measurement results . 27 5.3 Methods of measurement . 28 5.3.0 General requirement . 28 5.3.1 Frequency error . 29 5.3.1.0 General remark . 29 5.3.1.1 Method of measurement for systems with an unmodulated carrier frequency provision . 29 5.3.1.2 Method of measurement for systems with a modulated carrier frequency . 30 5.3.2 Emission bandwidth measurement . 30 5.3.3 Effective radiated power of the fundamental emission . 31 5.3.4 Spurious emissions of transmitter . 32 5.3.5 Frequency stability under low voltage conditions . 33 5.3.6 Spurious radiation of receivers . 33 5.3.6.0 Overview . 33 5.3.6.1 Spurious radiation of receivers . 33 5.3.6.2 Method of measuring the spurious radiations of receivers . 33 5.3.7 Receiver blocking . 34 5.3.7.0 General remarks . 34 5.3.7.1 Measurement method using out-of-operating-region disturbance . 34 SIST EN 302 537 V2.1.1:2016
ETSI ETSI EN 302 537 V2.1.1 (2016-10) 5 5.3.7.2 Measurement method using frequency administration commands . 35 5.3.7.3 Results based on the above test method . 35 5.3.8 Spectrum Access . 35 5.3.8.1 LBT/AFA spectrum access . 35 5.3.8.1.0 General provisions . 35 5.3.8.1.1 LBT threshold power level . 36 5.3.8.1.2 Monitoring system bandwidth . 38 5.3.8.1.3 Monitoring system scan cycle time and minimum channel monitoring period . 39 5.3.8.1.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh . 40 5.3.8.1.5 Discontinuation of MEDS session if a silent period greater than or equal to 5 s occurs . 41 5.3.8.1.6 Use of pre-scanned alternate channel . 42 5.3.8.2 Spectrum access based on low power and low duty cycle . 44 5.3.8.2.0 Overview . 44 5.3.8.2.1 Methods of measurement. 44 Annex A (normative): Relationship between the present document and the essential requirements of Directive 2014/53/EU . 46 Annex B (normative): Radiated measurements . 47 B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 47 B.1.1 Outdoor test site . 47 B.1.1.0 Introduction. 47 B.1.1.1 Standard position . 48 B.1.1.2 Equipment in close proximity to the human body but external to it . 48 B.1.1.3 Human torso simulator for ULP-BWD and ULP-AMI . 48 B.1.2 Test antenna . 49 B.1.3 Substitution antenna . 49 B.1.4 Optional additional indoor site . 50 B.2 Guidance on the use of radiation test sites . 51 B.2.0 Introduction . 51 B.2.1 Measuring distance . 51 B.2.2 Test antenna . 51 B.2.3 Substitution antenna . 51 B.2.4 Artificial antenna . 51 B.2.5 Auxiliary cables . 51 B.3 Further optional alternative indoor test site using a fully anechoic chamber . 52 B.3.0 Introduction . 52 B.3.1 Example of the construction of a fully anechoic chamber . 52 B.3.2 Influence of parasitic reflections in fully anechoic chambers . 52 B.3.3 Calibration of the fully anechoic chamber . 53 Annex C (normative): Technical performance of the spectrum analyser . 55 Annex D (informative): Bibliography . 56 History . 57
SIST EN 302 537 V2.1.1:2016
ETSI ETSI EN 302 537 V2.1.1 (2016-10) 6 Intellectual Property Rights IPRs essential or potentially essential to the present document may have been declared to ETSI. The information pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web server (https://ipr.etsi.org/). Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web server) which are, or may be, or may become, essential to the present document. Foreword This 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.11] 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: 12 September 2016 Date of latest announcement of this EN (doa): 31 December 2016 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
30 June 2017 Date of withdrawal of any conflicting National Standard (dow): 30 June 2018
Modal verbs terminology In the present document "shall", "shall not", "should", "should not", "may", "need not", "will", "will not", "can" and "cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of provisions). "must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation. Introduction The present document covers the ultra low power radio devices used in a Medical Data Service and the various types of devices that form part of the system providing the service. It includes methods of measurement and requirements for radio systems used in the service that are fitted with an antenna connector and/or having an integral
...
ETSI EN 302 537 V2.1.1 (2016-10)
HARMONISED EUROPEAN STANDARD
Ultra Low Power Medical Data Service (MEDS)
Systems operating in the frequency range
401 MHz to 402 MHz and 405 MHz to 406 MHz;
Harmonised Standard covering the essential requirements
of article 3.2 of the Directive 2014/53/EU
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2 ETSI EN 302 537 V2.1.1 (2016-10)
Reference
REN/ERM-TG30-307
Keywords
harmonised standard, radio, regulation, testing
ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE
Tel.: +33 4 92 94 42 00 Fax: +33 4 93 65 47 16
Siret N° 348 623 562 00017 - NAF 742 C
Association à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88
Important notice
The present document can be downloaded from:
http://www.etsi.org/standards-search
The present document may be made available in electronic versions and/or in print. The content of any electronic and/or
print versions of the present document shall not be modified without the prior written authorization of ETSI. In case of any
existing or perceived difference in contents between such versions and/or in print, the only prevailing document is the
print of the Portable Document Format (PDF) version kept on a specific network drive within ETSI Secretariat.
Users of the present document should be aware that the document may be subject to revision or change of status.
Information on the current status of this and other ETSI documents is available at
https://portal.etsi.org/TB/ETSIDeliverableStatus.aspx
If you find errors in the present document, please send your comment to one of the following services:
https://portal.etsi.org/People/CommiteeSupportStaff.aspx
Copyright Notification
No part may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying
and microfilm except as authorized by written permission of ETSI.
The content of the PDF version shall not be modified without the written authorization of ETSI.
The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2016.
All rights reserved.
TM TM TM
DECT , PLUGTESTS , UMTS and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members.
TM
3GPP and LTE™ are Trade Marks of ETSI registered for the benefit of its Members and
of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI
---------------------- Page: 2 ----------------------
3 ETSI EN 302 537 V2.1.1 (2016-10)
Contents
Intellectual Property Rights . 6
Foreword . 6
Modal verbs terminology . 6
Introduction . 6
1 Scope . 8
2 References . 9
2.1 Normative references . 9
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 10
3.1 Definitions . 10
3.2 Symbols . 12
3.3 Abbreviations . 13
4 Technical requirements specifications . 14
4.1 Environmental profile . 14
4.2 Conformance requirements . 14
4.2.1 Transmitter requirements . 14
4.2.1.1 Frequency error . 14
4.2.1.1.1 Definition. 14
4.2.1.1.2 Limits . 14
4.2.1.1.3 Conformance . 14
4.2.1.2 Emission bandwidth . 14
4.2.1.2.1 Definition. 14
4.2.1.2.2 Limits . 14
4.2.1.2.3 Conformance . 14
4.2.1.3 Effective radiated power of the fundamental emission . 15
4.2.1.3.0 General requirement . 15
4.2.1.3.1 Definition. 15
4.2.1.3.2 Limits . 15
4.2.1.3.3 Conformance . 15
4.2.1.4 Spurious emissions of transmitter . 15
4.2.1.4.0 General requirement . 15
4.2.1.4.1 Definition. 16
4.2.1.4.2 Limits . 16
4.2.1.4.3 Conformance . 16
4.2.1.5 Frequency stability under low voltage conditions . 16
4.2.1.5.1 Definition. 16
4.2.1.5.2 Limits . 16
4.2.1.5.3 Conformance . 16
4.2.2 Receiver requirements . 17
4.2.2.1 Spurious radiation of receivers . 17
4.2.2.1.1 Definition. 17
4.2.2.1.2 Limits . 17
4.2.2.1.3 Conformance . 17
4.2.2.2 Receiver blocking . 17
4.2.2.2.1 Definition. 17
4.2.2.2.2 Limits . 17
4.2.2.2.3 Conformance . 17
4.2.3 Transmitter and Receiver requirements . 17
4.2.3.1 Spectrum Access . 17
4.2.3.1.0 General requirements . 17
4.2.3.1.1 LBT/AFA spectrum access . 18
4.2.3.1.2 Low Power Low Duty Cycle spectrum access . 19
4.3 Mechanical and electrical design . 19
4.3.1 General . 19
ETSI
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4 ETSI EN 302 537 V2.1.1 (2016-10)
4.3.2 Antennas . 19
4.3.3 Controls . 19
4.3.4 Transmitter shut-off facility . 19
4.3.5 Void . 20
4.3.6 Equipment identification . 20
5 Testing for compliance with technical requirements . 20
5.1 Environmental conditions for testing . 20
5.1.0 General remark . 20
5.1.1 Presentation of equipment for testing purposes . 20
5.1.1.0 General remark . 20
5.1.1.1 Choice of model for testing . 20
5.1.1.2 Testing of equipment with alternative power levels . 21
5.1.1.3 Testing of equipment that does not have an external 50 Ω RF connector (integral antenna
equipment) . 21
5.1.1.3.1 Equipment with an internal permanent or temporary antenna connector . 21
5.1.1.3.2 Equipment with a temporary antenna connector . 21
5.1.1.3.3 Equipment intended to be implanted in or worn on but totally external to a human body . 21
5.1.2 Declarations by the provider . 21
5.1.3 Auxiliary test equipment . 21
5.1.4 Test Conditions . 21
5.1.4.1 Normal and extreme test conditions . 21
5.1.4.2 Test power source . 22
5.1.4.2.0 General remark . 22
5.1.4.2.1 External test power source . 22
5.1.4.2.2 Internal test power source . 22
5.1.4.3 Normal test conditions . 22
5.1.4.3.1 Normal temperature and humidity . 22
5.1.4.3.2 Normal test power source . 23
5.1.4.4 Extreme test conditions . 23
5.1.4.4.1 Extreme temperatures . 23
5.1.4.4.2 Extreme test source voltages . 24
5.1.4.5 Normal test signals and test modulation. 25
5.1.4.5.0 General remark . 25
5.1.4.5.1 Normal modulation test signals for data . 25
5.1.4.6 Antennas . 26
5.1.4.6.0 General remark . 26
5.1.4.6.1 Artificial antenna . 26
5.1.4.6.2 Artificial antenna for transmitters with 50 Ω impedance connector . 26
5.1.4.7 Test fixture for ULP-AMD, ULP-AMD-P and ULP-AMI-P devices . 26
5.1.4.8 Test fixture for ULP-AMI and ULP-BWD . 27
5.1.4.9 Test sites and general arrangements for radiated measurements . 27
5.1.4.10 Modes of operation of the transmitter . 27
5.1.4.11 Measuring receiver . 27
5.2 Interpretation of the measurement results . 27
5.3 Methods of measurement . 28
5.3.0 General requirement . 28
5.3.1 Frequency error . 29
5.3.1.0 General remark . 29
5.3.1.1 Method of measurement for systems with an unmodulated carrier frequency provision . 29
5.3.1.2 Method of measurement for systems with a modulated carrier frequency . 30
5.3.2 Emission bandwidth measurement . 30
5.3.3 Effective radiated power of the fundamental emission . 31
5.3.4 Spurious emissions of transmitter . 32
5.3.5 Frequency stability under low voltage conditions . 33
5.3.6 Spurious radiation of receivers . 33
5.3.6.0 Overview . 33
5.3.6.1 Spurious radiation of receivers . 33
5.3.6.2 Method of measuring the spurious radiations of receivers . 33
5.3.7 Receiver blocking . 34
5.3.7.0 General remarks . 34
5.3.7.1 Measurement method using out-of-operating-region disturbance . 34
ETSI
---------------------- Page: 4 ----------------------
5 ETSI EN 302 537 V2.1.1 (2016-10)
5.3.7.2 Measurement method using frequency administration commands . 35
5.3.7.3 Results based on the above test method . 35
5.3.8 Spectrum Access . 35
5.3.8.1 LBT/AFA spectrum access . 35
5.3.8.1.0 General provisions . 35
5.3.8.1.1 LBT threshold power level . 36
5.3.8.1.2 Monitoring system bandwidth . 38
5.3.8.1.3 Monitoring system scan cycle time and minimum channel monitoring period . 39
5.3.8.1.4 Channel access based on ambient levels relative to the calculated access LBT threshold level,
P . 40
Th
5.3.8.1.5 Discontinuation of MEDS session if a silent period greater than or equal to 5 s occurs . 41
5.3.8.1.6 Use of pre-scanned alternate channel . 42
5.3.8.2 Spectrum access based on low power and low duty cycle . 44
5.3.8.2.0 Overview . 44
5.3.8.2.1 Methods of measurement. 44
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 46
Annex B (normative): Radiated measurements . 47
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 47
B.1.1 Outdoor test site . 47
B.1.1.0 Introduction. 47
B.1.1.1 Standard position . 48
B.1.1.2 Equipment in close proximity to the human body but external to it . 48
B.1.1.3 Human torso simulator for ULP-BWD and ULP-AMI . 48
B.1.2 Test antenna . 49
B.1.3 Substitution antenna . 49
B.1.4 Optional additional indoor site . 50
B.2 Guidance on the use of radiation test sites . 51
B.2.0 Introduction . 51
B.2.1 Measuring distance . 51
B.2.2 Test antenna . 51
B.2.3 Substitution antenna . 51
B.2.4 Artificial antenna . 51
B.2.5 Auxiliary cables . 51
B.3 Further optional alternative indoor test site using a fully anechoic chamber . 52
B.3.0 Introduction . 52
B.3.1 Example of the construction of a fully anechoic chamber . 52
B.3.2 Influence of parasitic reflections in fully anechoic chambers . 52
B.3.3 Calibration of the fully anechoic chamber . 53
Annex C (normative): Technical performance of the spectrum analyser . 55
Annex D (informative): Bibliography . 56
History . 57
ETSI
---------------------- Page: 5 ----------------------
6 ETSI EN 302 537 V2.1.1 (2016-10)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (https://ipr.etsi.org/).
Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee
can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web
server) which are, or may be, or may become, essential to the present document.
Foreword
This 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.11] 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: 12 September 2016
Date of latest announcement of this EN (doa): 31 December 2016
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 30 June 2017
Date of withdrawal of any conflicting National Standard (dow): 30 June 2018
Modal verbs terminology
In the present document "shall", "shall not", "should", "should not", "may", "need not", "will", "will not", "can" and
"cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of
provisions).
"must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation.
Introduction
The present document covers the ultra low power radio devices used in a Medical Data Service and the various types of
devices that form part of the system providing the service. It includes methods of measurement and requirements for
radio systems used in the service that are fitted with an antenna connector and/or having an integral antenna. If a device
which is operating in the MEDS and is available on the market is required to be checked, it should be tested in
accordance with the methods of measurement specified in the pres
...
Draft ETSI EN 302 537 V2.0.1 (2016-06)
HARMONISED EUROPEAN STANDARD
Ultra Low Power Medical Data Service (MEDS)
Systems operating in the frequency range
401 MHz to 402 MHz and 405 MHz to 406 MHz;
Harmonised Standard covering the essential requirements
of article 3.2 of the Directive 2014/53/EU
---------------------- Page: 1 ----------------------
2 Draft ETSI EN 302 537 V2.0.1 (2016-06)
Reference
REN/ERM-TG30-307
Keywords
harmonised standard, radio, regulation, testing
ETSI
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© European Telecommunications Standards Institute 2016.
All rights reserved.
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DECT , PLUGTESTS , UMTS and the ETSI logo are Trade Marks of ETSI registered for the benefit of its Members.
TM
3GPP and LTE™ are Trade Marks of ETSI registered for the benefit of its Members and
of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI
---------------------- Page: 2 ----------------------
3 Draft ETSI EN 302 537 V2.0.1 (2016-06)
Contents
Intellectual Property Rights . 6
Foreword . 6
Modal verbs terminology . 6
Introduction . 6
1 Scope . 8
2 References . 8
2.1 Normative references . 8
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 10
3.1 Definitions . 10
3.2 Symbols . 12
3.3 Abbreviations . 13
4 Technical requirements specifications . 13
4.1 Environmental profile . 13
4.2 Conformance requirements . 14
4.2.1 Transmitter requirements . 14
4.2.1.1 Frequency error . 14
4.2.1.1.1 Definition. 14
4.2.1.1.2 Limits . 14
4.2.1.1.3 Conformance . 14
4.2.1.2 Emission bandwidth . 14
4.2.1.2.1 Definition. 14
4.2.1.2.2 Limits . 14
4.2.1.2.3 Conformance . 14
4.2.1.3 Effective radiated power of the fundamental emission . 14
4.2.1.3.0 General requirement . 14
4.2.1.3.1 Definition. 15
4.2.1.3.2 Limits . 15
4.2.1.3.3 Conformance . 15
4.2.1.4 Spurious emissions of transmitter . 15
4.2.1.4.0 General requirement . 15
4.2.1.4.1 Definition. 15
4.2.1.4.2 Limits . 16
4.2.1.4.3 Conformance . 16
4.2.1.5 Frequency stability under low voltage conditions . 16
4.2.1.5.1 Definition. 16
4.2.1.5.2 Limits . 16
4.2.1.5.3 Conformance . 16
4.2.2 Receiver requirements . 16
4.2.2.1 Spurious radiation of receivers . 16
4.2.2.1.1 Definition. 16
4.2.2.1.2 Limits . 17
4.2.2.1.3 Conformance . 17
4.2.2.2 Receiver blocking . 17
4.2.2.2.1 Definition. 17
4.2.2.2.2 Limits . 17
4.2.2.2.3 Conformance . 17
4.2.3 Transmitter and Receiver requirements . 17
4.2.3.1 Spectrum Access . 17
4.2.3.1.0 General requirements . 17
4.2.3.1.1 LBT/AFA spectrum access . 18
4.2.3.1.2 Low Power Low Duty Cycle spectrum access . 18
4.3 Mechanical and electrical design . 19
4.3.1 General . 19
ETSI
---------------------- Page: 3 ----------------------
4 Draft ETSI EN 302 537 V2.0.1 (2016-06)
4.3.2 Antennas . 19
4.3.3 Controls . 19
4.3.4 Transmitter shut-off facility . 19
4.3.5 Marking . 19
4.3.6 Equipment identification . 19
5 Testing for compliance with technical requirements . 20
5.1 Environmental conditions for testing . 20
5.1.0 General remark . 20
5.1.1 Presentation of equipment for testing purposes . 20
5.1.1.0 General remark . 20
5.1.1.1 Choice of model for testing . 20
5.1.1.2 Testing of equipment with alternative power levels . 20
5.1.1.3 Testing of equipment that does not have an external 50 Ω RF connector (integral antenna
equipment) . 21
5.1.1.3.1 Equipment with an internal permanent or temporary antenna connector . 21
5.1.1.3.2 Equipment with a temporary antenna connector . 21
5.1.1.3.3 Equipment intended to be implanted in or worn on but totally external to a human body . 21
5.1.2 Declarations by the provider . 21
5.1.3 Auxiliary test equipment . 21
5.1.4 Test Conditions . 21
5.1.4.1 Normal and extreme test conditions . 21
5.1.4.2 Test power source . 22
5.1.4.2.0 General remark . 22
5.1.4.2.1 External test power source . 22
5.1.4.2.2 Internal test power source . 22
5.1.4.3 Normal test conditions . 22
5.1.4.3.1 Normal temperature and humidity . 22
5.1.4.3.2 Normal test power source . 23
5.1.4.4 Extreme test conditions . 23
5.1.4.4.1 Extreme temperatures . 23
5.1.4.4.2 Extreme test source voltages . 24
5.1.4.5 Normal test signals and test modulation. 25
5.1.4.5.0 General remark . 25
5.1.4.5.1 Normal modulation test signals for data . 25
5.1.4.6 Antennas . 26
5.1.4.6.0 General remark . 26
5.1.4.6.1 Artificial antenna . 26
5.1.4.6.2 Artificial antenna for transmitters with 50 Ω impedance connector . 26
5.1.4.7 Test fixture for ULP-AMD, ULP-AMD-P and ULP-AMI-P devices . 26
5.1.4.8 Test fixture for ULP-AMI and ULP-BWD . 27
5.1.4.9 Test sites and general arrangements for radiated measurements . 27
5.1.4.10 Modes of operation of the transmitter . 27
5.1.4.11 Measuring receiver . 27
5.2 Interpretation of the measurement results . 27
5.3 Methods of measurement . 28
5.3.0 General requirement . 28
5.3.1 Frequency error . 29
5.3.1.0 General remark . 29
5.3.1.1 Method of measurement for systems with an unmodulated carrier frequency provision . 29
5.3.1.2 Method of measurement for systems with a modulated carrier frequency . 30
5.3.2 Emission bandwidth measurement . 30
5.3.3 Effective radiated power of the fundamental emission . 31
5.3.4 Spurious emissions of transmitter . 32
5.3.5 Frequency stability under low voltage conditions . 33
5.3.6 Spurious radiation of receivers . 33
5.3.6.0 Overview . 33
5.3.6.1 Spurious radiation of receivers . 33
5.3.6.2 Method of measuring the spurious radiations of receivers . 33
5.3.7 Receiver blocking . 34
5.3.7.0 General remarks . 34
5.3.7.1 Measurement method using out-of-operating-region disturbance . 34
ETSI
---------------------- Page: 4 ----------------------
5 Draft ETSI EN 302 537 V2.0.1 (2016-06)
5.3.7.2 Measurement method using frequency administration commands . 35
5.3.7.3 Results based on the above test method . 35
5.3.8 Spectrum Access . 35
5.3.8.1 LBT/AFA spectrum access . 35
5.3.8.1.0 General provisions . 35
5.3.8.1.1 LBT threshold power level . 36
5.3.8.1.2 Monitoring system bandwidth . 38
5.3.8.1.3 Monitoring system scan cycle time and minimum channel monitoring period . 39
5.3.8.1.4 Channel access based on ambient levels relative to the calculated access LBT threshold level,
P . 40
Th
5.3.8.1.5 Discontinuation of MEDS session if a silent period greater than or equal to 5 s occurs . 41
5.3.8.1.6 Use of pre-scanned alternate channel . 42
5.3.8.2 Spectrum access based on low power and low duty cycle . 44
5.3.8.2.0 Overview . 44
5.3.8.2.1 Methods of measurement. 44
Annex A (normative): Relationship between the present document and the essential
requirements of Directive 2014/53/EU . 46
Annex B (normative): Radiated measurements . 47
B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 47
B.1.1 Outdoor test site . 47
B.1.1.0 Introduction. 47
B.1.1.1 Standard position . 48
B.1.1.2 Equipment in close proximity to the human body but external to it . 48
B.1.1.3 Human torso simulator for ULP-BWD and ULP-AMI . 48
B.1.2 Test antenna . 49
B.1.3 Substitution antenna . 49
B.1.4 Optional additional indoor site . 50
B.2 Guidance on the use of radiation test sites . 51
B.2.0 Introduction . 51
B.2.1 Measuring distance . 51
B.2.2 Test antenna . 51
B.2.3 Substitution antenna . 51
B.2.4 Artificial antenna . 51
B.2.5 Auxiliary cables . 51
B.3 Further optional alternative indoor test site using a fully anechoic chamber . 52
B.3.0 Introduction . 52
B.3.1 Example of the construction of a fully anechoic chamber . 52
B.3.2 Influence of parasitic reflections in fully anechoic chambers . 52
B.3.3 Calibration of the fully anechoic chamber . 53
Annex C (normative): Technical performance of the spectrum analyser . 55
Annex D (informative): Bibliography . 56
History . 57
ETSI
---------------------- Page: 5 ----------------------
6 Draft ETSI EN 302 537 V2.0.1 (2016-06)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (https://ipr.etsi.org/).
Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee
can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web
server) which are, or may be, or may become, essential to the present document.
Foreword
This draft Harmonised European Standard (EN) has been produced by ETSI Technical Committee Electromagnetic
compatibility and Radio spectrum Matters (ERM), and is now submitted for the combined Public Enquiry and Vote
phase of the ETSI standards EN Approval Procedure.
The present document has been prepared under the Commission's standardisation request C(2015) 5376 final [i.11] 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.
Introduction
The present document covers the ultra low power radio devices used in a Medical Data Service and the various types of
devices that form part of the system providing the service. It includes methods of measurement and requirements for
radio systems used in the service that are fitted with an antenna connector and/or having an integral antenna. If a device
which is operating in the MEDS and
...
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