1、 ETSI EN 302 536 V2.1.1 (2017-10) Short Range Devices (SRD); Radio equipment operating in the frequency range 315 kHz to 600 kHz for Ultra Low Power Animal Implantable Devices (ULP-AID) and associated peripherals; Harmonised Standard covering the essential requirements of article 3.2 of Directive 20
2、14/53/EU HARMONISED EUROPEAN STANDARD ETSI ETSI EN 302 536 V2.1.1 (2017-10) 2 Reference REN/ERM-TG30-309 Keywords harmonised standard, inductive, radio, regulation 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 0
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9、ogo are trademarks registered and owned by the GSM Association. ETSI ETSI EN 302 536 V2.1.1 (2017-10) 3 Contents Intellectual Property Rights 6g3Foreword . 6g3Modal verbs terminology 6g3Introduction 7g31 Scope 8g32 References 8g32.1 Normative references . 8g32.2 Informative references 8g33 Definitio
10、ns, symbols and abbreviations . 9g33.1 Definitions 9g33.2 Symbols 10g33.3 Abbreviations . 10g34 Technical requirements specifications . 10g34.1 Environmental profile . 10g34.1.0 General requirements 10g34.1.1 Conformance requirements . 11g34.2 Transmitter requirements . 11g34.2.1 Radiated Field Stre
11、ngth 11g34.2.1.1 Definition 11g34.2.1.2 Limits 11g34.2.1.3 Conformance . 11g34.2.2 Permitted range of modulation bandwidth 11g34.2.2.0 General 11g34.2.2.1 Definition 11g34.2.2.2 Limits 11g34.2.2.3 Conformance . 11g34.2.3 Transmitter Spurious emissions 12g34.2.3.1 Definition 12g34.2.3.2 Limits 12g34.
12、2.3.3 Conformance . 12g34.2.4 Duty Cycle 12g34.2.4.1 Definition 12g34.2.4.2 Limits 12g34.2.4.3 Conformance . 12g34.3 Receiver requirements 13g34.3.1 Receiver Classification . 13g34.3.2 Receiver Blocking 13g34.3.2.1 Definition 13g34.3.2.2 Limits 13g34.3.2.3 Conformance . 13g34.3.3 Receiver spurious r
13、adiations . 14g34.3.3.0 General 14g34.3.3.1 Definition 14g34.3.3.2 Limits 14g34.3.3.3 Conformance . 14g35 Testing for compliance with technical requirements 14g35.0 General requirement . 14g35.1 Normal test signals and test modulation . 14g35.1.0 General requirement . 14g35.1.1 Normal test signals f
14、or data 14g35.2 Antenna 15g35.2.0 General remark . 15g35.2.1 Artificial antenna 15g3ETSI ETSI EN 302 536 V2.1.1 (2017-10) 4 5.3 Test fixture . 15g35.3.0 General remark . 15g35.3.1 Alternate test fixture for equipment intended to be implanted within and transmitters worn on the body of the animal 16g
15、35.4 Test sites and general arrangements for radiated measurements 16g35.5 Modes of operation of the transmitter 16g35.5.0 General remark . 16g35.5.1 Presentation of equipment for testing purposes 16g35.5.2 Choice of model for testing 17g35.5.3 Presentation of equipment that does not have an externa
16、l 50 uni2126 RF connector (integral antenna equipment) 17g35.5.3.0 General remark 17g35.5.3.1 Equipment with an internal permanent or temporary antenna connector 17g35.5.3.2 Equipment with a temporary antenna connector . 17g35.5.4 Controls 17g35.5.5 Transmitter shut-off facility 17g35.5.6 Receiver p
17、ower save capability 17g35.5.7 Declarations by the Applicant . 18g35.5.8 Auxiliary test equipment . 18g35.6 Normal and extreme test conditions . 18g35.6.0 General remark . 18g35.6.1 Test power source . 18g35.6.2 External test power source 18g35.6.3 Internal test power source . 18g35.7 Normal test co
18、nditions 19g35.7.1 Normal temperature and humidity 19g35.7.2 Normal test power source . 19g35.7.2.1 Mains voltage 19g35.7.2.2 Regulated lead-acid battery power sources . 19g35.7.2.3 Other power sources 19g35.8 Extreme test conditions 20g35.8.1 Extreme temperatures . 20g35.8.1.1 Procedure for tests a
19、t extreme temperatures 20g35.8.1.2 Procedure for equipment designed for continuous operation 20g35.8.1.3 Procedure for equipment designed for intermittent operation . 20g35.8.1.4 Extreme temperature ranges 21g35.8.2 Extreme test source voltages . 21g35.8.2.1 Mains voltage 21g35.8.2.2 Regulated lead-
20、acid battery power sources . 21g35.8.2.3 Power sources using other types of batteries . 21g35.8.2.4 Other power sources 22g35.9 Test sites and general arrangements for radiated measurements 22g35.10 Measuring receiver . 22g35.11 Interpretation of the measurement results 22g35.12 Transmitter measurem
21、ents 23g35.12.0 General remark . 23g35.12.1 Transmitter design specifications . 23g35.12.1.0 Antenna requirements . 23g35.12.1.1 The inductive loop coil transmitters 23g35.12.1.2 Antenna type . 24g35.12.2 Radiated Field Strength 24g35.12.2.1 Radiated H-field 24g35.12.2.1.1 General remark 24g35.12.2.
22、1.2 Methods of measurement. 24g35.12.3 Permitted frequency range of the modulation bandwidth . 25g35.12.3.1 General remark 25g35.12.3.2 Method of measurement 25g35.12.4 Transmitter Spurious emissions 25g35.12.4.1 Radiated field strength 25g35.12.4.1.1 Methods of measurement ( 30 MHz). 25g35.12.5 Dut
23、y cycle . 26g35.12.5.1 Declaration 26g3ETSI ETSI EN 302 536 V2.1.1 (2017-10) 5 5.13 Receiver Requirement 26g35.13.1 Receiver spurious radiation. 26g35.13.1.1 General remark 26g35.13.1.2 Methods of measurement 26g35.14 Receiver Blocking 26g35.14.1 Measurement procedure 26g3Annex A (informative): Rela
24、tionship between the present document and the essential requirements of Directive 2014/53/EU . 28g3Annex B (normative): Radiated measurements 29g3B.1 Test sites and general arrangements for measurements involving the use of radiated fields . 29g3B.1.1 Outdoor test site . 29g3B.1.1.0 General remarks
25、29g3B.1.1.1 Standard position 29g3B.1.1.2 Equipment in close proximity to the animal body but external to it . 30g3B.1.1.3 Active medical implant equipment (ULP-AID) 30g3B.1.2 Test antenna 31g3B.1.2.1 Below 30 MHz 31g3B.1.3 Optional additional indoor site . 31g3B.2 Guidance on the use of radiation t
26、est sites . 32g3B.2.0 General . 32g3B.2.1 Measuring distance . 32g3B.2.2 Auxiliary cables 32g3Annex C (normative): H-field measurements at distances other than 10 m . 33g3Annex D (informative): Bibliography . 35g3Annex E (informative): Change History 36g3History 37g3ETSI ETSI EN 302 536 V2.1.1 (2017
27、-10) 6 Intellectual Property Rights Essential patents 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 31
28、4: “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 investigati
29、on, 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
30、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 p
31、resent 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 presen
32、t document has been prepared under the Commissions standardization request C (2015) 5376 final i.4 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 o
33、f radio equipment and repealing Directive 1999/5/EC i.1. 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 docu
34、ment, 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: 9 October 2017 Date of latest announcement of this EN (doa): 31 January 2018 Date of latest publication of new
35、National Standard or endorsement of this EN (dop/e): 31 July 2018 Date of withdrawal of any conflicting National Standard (dow): 31 July 2019 Modal verbs terminology In the present document “shall“, “shall not“, “should“, “should not“, “may“, “need not“, “will“, “will not“, “can“ and “cannot“ are to
36、 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 302 536 V2.1.1 (2017-10) 7 Introduction Animal Implant Devices (AIDs) an
37、d associated peripheral equipment are a technology in the medical field that supports the development of new drugs and surgical procedures that are under development by pharmaceutical firms, medically related research college and university institutions. AIDs provide, on a continuing basis, data rel
38、ated to the physical effects of new drugs and the efficacy of new surgical procedures after the implant is inserted. These animals are typically housed in commercial surroundings such as laboratory environments or similar facilities such as colleges and universities. The present document is structur
39、ed 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 and symbols and abbreviations used. Clause 4 specifies the requirements and limits relative to transmitter, receiver, and spectrum access. Clause 5
40、specifies the methods of measurement for the parameters specified in clause 4. Annex A (informative) provides the relationship between the present document and the essential requirements of Directive 2014/53/EU i.1. Annex B (normative) provides specifications concerning radiated measurements. Annex
41、C (normative) provides technical relationship between the radiating H-field and measurement distance. Annex D (informative) bibliography; provides additional information. ETSI ETSI EN 302 536 V2.1.1 (2017-10) 8 1 Scope The present document specifies technical characteristics and methods of measureme
42、nts for Ultra Low Power-Animal Implant Devices (ULP-AIDs) and Peripherals as used by industry to develop new drugs and surgical techniques that provide improved health care for the benefit of human patients. ULP-AIDs operate in a Communications System using inductive technology in the frequency band
43、 315 kHz to 600 kHz. Table 1: Ultra Low Power Animal Implants and Peripherals Operating in the frequency band 315 kHz to 600 kHz Ultra Low Power Animal Implants and Peripherals service frequency bands Transmitters - Ultra Low Power Animal Implants and Peripherals 315 kHz to 600 kHz Receivers - Ultra
44、 Low Power Animal Implants and Peripherals 315 kHz to 600 kHz g3The present document contains the technical requirements for characteristics of ULP-AID and ULP-AID-P radio equipment which are aligned with annex 12 sub-band (c) of CEPT/ERC Recommendation 70-03 i.3. The frequency usage conditions for
45、the bands 315 kHz to 600 kHz are EU wide harmonised for the SRD category “active medical implant devices“ according to 2013/752/EU i.6 with the following usage restrictions: “This set of usage conditions is only available to animal implantable devices“. The present document covers the essential requ
46、irements of article 3.2 of Directive 2014/53/EU i.1 under the conditions identified in annex A for Ultra Low Power Animal Implants and peripherals used in an implant communications system that supports development of medically related treatments that provide improved health care for patients. It doe
47、s not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable. 2 References 2.1 Normative references References are specific, identified by date of publication and/or edition number or version number. Only the
48、 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 vali
49、dity. The following referenced document is necessary for the application of the present document. 1 CISPR 16-2-3 (2016): “Specification for radio disturbance and immunity measuring apparatus and methods. Part 2-3: Methods of measurement of disturbances and immunity - Radiated disturbance measurements“. 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
