1、 ETSI EN 303 203 V2.1.1 (2015-11) Short Range Devices (SRD); Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU HARMONISED EUROPEAN STANDARD ETSI ETSI EN 303 20
2、3 V2.1.1 (2015-11) 2 Reference REN/ERM-TG30-311 Keywords health, network, radio, regulation, SRD, system 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
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9、 203 V2.1.1 (2015-11) 3 Contents Intellectual Property Rights 6g3Foreword . 6g3Modal verbs terminology 6g3Introduction 7g31 Scope 8g32 References 8g32.1 Normative references . 8g32.2 Informative references 8g33 Definitions, symbols and abbreviations . 9g33.1 Definitions 9g33.2 Symbols 11g33.3 Abbrev
10、iations . 11g34 Technical requirements and specifications . 12g34.1 Environmental profile . 12g34.2 Conformance requirements 12g34.2.1 Transmitter requirements 12g34.2.1.1 Frequency Error 12g34.2.1.1.1 Definition. 12g34.2.1.1.2 Limits 12g34.2.1.1.3 Conformance . 12g34.2.1.2 Emission bandwidth 12g34.
11、2.1.2.1 Definition. 12g34.2.1.2.2 Limits 12g34.2.1.2.3 Conformance . 12g34.2.1.3 Effective isotropic radiated power 12g34.2.1.3.1 Definition. 12g34.2.1.3.2 Limits 12g34.2.1.3.3 Conformance . 13g34.2.1.4 Spurious emissions 13g34.2.1.4.1 Definition. 13g34.2.1.4.2 Limits 13g34.2.1.4.3 Conformance . 13g
12、34.2.1.5 Out-of-band emissions 13g34.2.1.5.1 Definition. 13g34.2.1.5.2 Limits 13g34.2.1.5.3 Conformance . 13g34.2.1.6 Frequency stability under low voltage conditions . 14g34.2.1.6.0 Applicability 14g34.2.1.6.1 Definition. 14g34.2.1.6.2 Limits 14g34.2.1.6.3 Conformance . 14g34.2.1.7 Duty cycle . 14g
13、34.2.1.7.0 General remarks. 14g34.2.1.7.1 Definition. 14g34.2.1.7.2 Limits 14g34.2.1.7.3 Conformance . 14g34.2.2 Receiver requirements 15g34.2.2.1 Spurious radiation . 15g34.2.2.1.1 Definition. 15g34.2.2.1.2 Limits 15g34.2.2.1.3 Conformance . 15g34.2.2.2 Receiver blocking . 15g34.2.2.2.1 Definition.
14、 15g34.2.2.2.2 Limits 15g3ETSI ETSI EN 303 203 V2.1.1 (2015-11) 4 4.2.2.2.3 Conformance . 15g34.2.3 Spectrum access 15g34.2.3.0 General requirements 15g34.2.3.1 LBT threshold power level 17g34.2.3.1.1 Definition. 17g34.2.3.1.2 Limits 17g34.2.3.1.3 Conformance . 17g34.2.3.2 Monitoring system bandwidt
15、h . 17g34.2.3.2.0 General remarks. 17g34.2.3.2.1 Definition. 17g34.2.3.2.2 Limits 17g34.2.3.2.3 Conformance . 17g34.2.3.3 Minimum channel monitoring period . 17g34.2.3.3.0 General remarks. 17g34.2.3.3.1 Definition. 17g34.2.3.3.2 Limits 17g34.2.3.3.3 Conformance . 18g34.2.3.4 Channel access based on
16、ambient levels relative to the calculated access LBT threshold level, PTh18g34.2.3.4.0 General requirements . 18g34.2.3.4.1 Conformance . 18g34.3 Mechanical and electrical design 18g34.3.1 General 18g34.3.2 Controls 18g34.3.3 Transmitter shut-off facility 18g35 Testing for compliance with technical
17、requirements 18g35.1 Environmental conditions for testing . 18g35.1.0 General requirements 18g35.1.1 Presentation for testing . 19g35.1.1.0 General provisions 19g35.1.1.1 Choice of model for testing . 19g35.1.1.2 Spurious emission testing for composite equipment . 19g35.1.1.3 Testing of equipment wi
18、th alternative power levels 19g35.1.1.4 Presentation of equipment that does not have an external RF connector (equipment with an integral antenna) 20g35.1.1.4.1 Equipment with a permanent or temporary internal antenna connector 20g35.1.1.4.2 Equipment with a temporary antenna connector . 20g35.1.2 D
19、eclarations by the applicant 20g35.1.3 Auxiliary test equipment . 20g35.1.4 Test conditions 20g35.1.4.1 Normal and extreme test conditions 20g35.1.4.2 Test power source . 20g35.1.4.2.0 General requirements . 20g35.1.4.2.1 External test power source . 20g35.1.4.2.2 Internal test power source 21g35.1.
20、4.3 Normal test conditions 21g35.1.4.3.1 Normal temperature and humidity . 21g35.1.4.3.2 Normal test power source 21g35.1.4.4 Extreme test conditions . 21g35.1.4.4.1 Extreme temperatures 21g35.1.4.4.2 Extreme test source voltages . 23g35.1.4.5 Normal test signals and test modulation 23g35.1.4.5.0 Ge
21、neral requirements. 23g35.1.4.5.1 Normal modulation test signals for data 23g35.1.4.6 Antennas . 23g35.1.4.7 Test fixture 23g35.1.4.8 Test sites and general arrangements for radiated measurements . 24g35.1.4.9 Modes of operation of the transmitter . 24g35.1.4.10 Measuring receiver 24g35.1.4.11 Gener
22、al remarks on configuration for transmitter measurements . 25g35.1.4.12 General remarks on configuration for receiver measurements 25g35.1.4.13 General remarks on configuration for monitoring system measurements . 26g3ETSI ETSI EN 303 203 V2.1.1 (2015-11) 5 5.2 Interpretation of the measurement resu
23、lts 26g35.3 Methods of measurement . 27g35.3.1 Frequency error . 27g35.3.1.0 General requirements 27g35.3.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode 27g35.3.1.2 Method of measurement for systems with a modulated output frequency 27g35.3.2 Emission band
24、width 28g35.3.3 Effective isotropic radiated power 28g35.3.4 Transmitter spurious emissions . 29g35.3.5 Out-of-band emissions 30g35.3.6 Frequency stability under low voltage conditions 32g35.3.7 Receiver spurious emissions . 32g35.3.8 LBT threshold power level . 33g35.3.8.0 General remarks 33g35.3.8
25、.1 Measurement method using frequency administration commands . 33g35.3.8.2 Results based on the above test method 33g35.3.9 Minimum channel monitoring period . 33g35.3.9.0 General remarks 33g35.3.9.1 Measurement method using frequency administration commands . 33g35.3.9.2 Results based on the above
26、 test method 34g35.3.10 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh34g35.3.10.0 Initial steps 34g35.3.10.1 Accessing an unoccupied channel . 34g35.3.10.2 Results accessing an unoccupied channel . 34g35.3.10.3 Accessing the Least Interfered Channe
27、l 34g35.3.10.4 Results accessing the Least Interfered Channel 34g35.3.11 Receiver blocking . 34g35.3.11.0 General remarks 34g35.3.11.1 Measurement method using frequency administration commands . 35g35.3.11.2 Results based on the above test method 35g3Annex A (normative): Relationship between the pr
28、esent document and the essential requirements of Directive 2014/53/EU . 36g3Annex B (normative): Radiated measurements 37g3B.1 Test sites and arrangements for radiated measurements 37g3B.1.1 Outdoor test site . 37g3B.1.2 Indoor test site 37g3B.1.3 Shielded anechoic test site 38g3B.2 Antennas . 40g3B
29、.2.1 Test antenna 40g3B.2.2 Substitution antenna . 40g3B.3 Test practice and auxiliary test equipment . 41g3B.3.0 General requirements . 41g3B.3.1 Measuring distance . 41g3B.3.2 Auxiliary cables 41g3Annex C (informative): Bibliography . 42g3History 43g3ETSI ETSI EN 303 203 V2.1.1 (2015-11) 6 Intelle
30、ctual 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
31、 (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 (http:/ipr.etsi.org). Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has be
32、en 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 E
33、TSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document has been prepared in reply to the Commissions standardisation request Commission Implementing Decision C(2015) 5376 final of 04.08.2015 to provide a means of conforming to the essential requi
34、rements 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 - also known as the Radio Equipment Directive i.3. Once the present document is cited in the Official Journal of the European Union under that Direc
35、tive, 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. The present document c
36、overs Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz range, as described in the systems reference document for the equipment, ETSI TR 101 557 i.1. National transposition dates Date of adoption of this EN: 2 November 2015 Date of latest announcement of this EN (d
37、oa): 29 February 2016 Date of latest publication of new National Standard or endorsement of this EN (dop/e): 31 August 2016 Date of withdrawal of any conflicting National Standard (dow): 31 August 2017 Modal verbs terminology In the present document “shall“, “shall not“, “should“, “should not“, “may
38、“, “need not“, “will“, “will not“, “can“ and “cannot“ are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of provisions). “must“ and “must not“ are NOT allowed in ETSI deliverables except when used in direct citation. ETSI ETSI EN 303 203 V2.1
39、.1 (2015-11) 7 Introduction The present document is part of a set of standards developed by ETSI and is designed to fit in a modular structure to cover all radio and telecommunications terminal equipment within the scope of the Radio Equipment Directive (RE-D) i.3. The modular structure is shown in
40、ETSI EG 201 399 i.4. The present document describes the technical characteristics and test and performance requirements for Medical Body Area Network Systems (MBANSs) operating in the 2 483,5 MHz to 2 500 MHz frequency range. Medical Body Area Networks are short-range low-power wireless networks, co
41、nsisting of a plurality of body-worn sensor devices and/or actuator devices and a hub device placed on/around the human body. The on-body sensor devices are responsible for measuring key patient-specific information, such as the temperature, pulse, blood glucose level, electrocardiogram, blood press
42、ure level and respiratory function readings. The hub device acts as a central controller to maintain the connections with all devices associated with its MBANS and is responsible for device association/de-association and channel selection. The hub device also typically receives the data collected fr
43、om the various sensor devices on the body and may, depending on applications, process the data locally and/or further forward it to a remote central station (e.g. remote nursing station) via an appropriate wired/wireless link for centralized processing, display and storage. Usually, MBANS devices ar
44、e highly resource-constrained in terms of battery capacity, MCU capability and memory size. Therefore, simple and low-power MBANS solutions are preferred from the application point of view. Currently, most of mature low-power low-cost short-range radio solutions have spectrum efficiency around or le
45、ss than 1 bps/Hz and it is expected that MBANS solutions will have similar spectrum efficiency. Also to prolong battery life, MBANS devices are expected to transmit with a limited duty cycle. The MBANS devices duty cycle is not more than 10 % for in-hospital applications and not more than 2 % for in
46、-home applications. In addition to the technical specifications, the present document provides measurement methods for MBANS equipment which should support operation in healthcare facility mode or home mode, or both modes. These measurement methods are to be implemented throughout the process of man
47、ufacturing and putting onto the market. Moreover, if the MBANS equipment is required to be checked for the purpose of market surveillance, it should be tested also in accordance with the methods of measurement specified in the present document. The present document is structured as follows: Clauses
48、1 through 3 provide a general description of the types of equipment covered by the present document and the definitions of terms and symbols and abbreviations used. Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access. The latter are primarily designe
49、d to minimize the possibility of disturbance between MBANS equipment and other users of the 2 483,5 MHz to 2 500 MHz frequency range. 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, related to transmitter, receiver, and spectrum access. Annex A (informative) provides an overview of the relationship between the present document and the essential requirements of RE-D. Annex B (normative) gives the specifications concerning radi
