SIST EN 301 839-1 V1.2.1:2007
Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz - Part 1: Technical characteristics and test methods
Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz - Part 1: Technical characteristics and test methods
The present document covers, for Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) used in a Medical Implant Communications Service (MICS), the required characteristics considered necessary to efficiently use the available spectrum and serve the interests of implant users. The specifications contained in the present document were developed to ensure that the health and safety of the patients that are using this equipment under the direction of medical practitioners is protected. Of particular importance is the inclusion of spectrum monitoring and access requirements (listen before talk protocol) designed to significantly reduce any interference potential between MICS systems operating in the band or between a MICS system and the primary users of the band. Also included in the present document is the capability of Low Duty Cycly/Low Power Access in the 403,5 MHz to 403,8 MHz frequency band. An AIMD is regulated under the AIMD Directive 90/385/EEC: radio parts contained therein (referred to herein as ULP-AMI and ULP-AMI-P for peripheral devices) are regulated under the Directive 1999/5/EC (R&TTE Directive) [1]. It is intended that the present document applies to operation in the band 402 MHz to 405 MHz only and that devices that can also operate in spectrum outside this band also meet any applicable requirements for operation in such bands. The present document contains the technical characteristics for ULP-AMI radio equipment which is also addressed by CEPT/ERC/REC 70-03 [2] and annex 12 to that document. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable. It applies to ULP-AMI devices and accessories operating in the band 402 MHz to 405 MHz:
- for telecommand and telemetry to/from an AIMD in a patient's body to an ULP-AMI-P; or
- for telecommand and telemetry to/from an AIMD to another AIMD within the human body;
- with or without an integral antenna; and/or
- with an antenna connection provided only for the purpose of connecting an external dedicated antenna. The present document covers requirements for radiated emissions above 25 MHz.
Elektromagnetna združljivost in zadeve v zvezi z radijskim spektrom (ERM) - Naprave kratkega dosega (SRD) - Aktivni medicinski vsadki ultra majhnih moči (ULP-AMI) in pripadajoče periferne naprave (ULP-AMI-P), ki delujejo v frekvenčnem območju od 402 MHz do 405 MHz - 1. del: Tehnične karakteristike in preskusne metode
General Information
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.PHWRGHElectromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz - Part 1: Technical characteristics and test methods33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.20Sprejemna in oddajna opremaReceiving and transmitting equipment11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 301 839-1 Version 1.2.1SIST EN 301 839-1 V1.2.1:2007en01-december-2007SIST EN 301 839-1 V1.2.1:2007SLOVENSKI
STANDARD
SIST EN 301 839-1 V1.2.1:2007
ETSI EN 301 839-1 V1.2.1 (2007-07)European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Short Range Devices (SRD);Ultra Low Power Active Medical Implants (ULP-AMI)and Peripherals (ULP-AMI-P)operating in the frequency range 402 MHz to 405 MHz;Part 1: Technical characteristics and test methods
SIST EN 301 839-1 V1.2.1:2007
ETSI ETSI EN 301 839-1 V1.2.1 (2007-07) 2
Reference REN/ERM-TG30-002-1 Keywords radio, SRD, testing ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
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Important notice Individual copies of the present document can be downloaded from: http://www.etsi.org The present document may be made available in more than one electronic version or in print. In any case of existing or perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF). In case of dispute, the reference shall be the printing on ETSI printers of the 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 http://portal.etsi.org/tb/status/status.asp If you find errors in the present document, please send your comment to one of the following services: http://portal.etsi.org/chaircor/ETSI_support.asp Copyright Notification No part may be reproduced except as authorized by written permission. The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2007. All rights reserved.
DECTTM, PLUGTESTSTM and UMTSTM are Trade Marks of ETSI registered for the benefit of its Members. TIPHONTM and the TIPHON logo are Trade Marks currently being registered by ETSI for the benefit of its Members. 3GPPTM is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. SIST EN 301 839-1 V1.2.1:2007
ETSI ETSI EN 301 839-1 V1.2.1 (2007-07) 3
Contents Intellectual Property Rights.6 Foreword.6 Introduction.7 1 Scope.8 2 References.8 3 Definitions, symbols and abbreviations.9 3.1 Definitions.9 3.2 Symbols.11 3.3 Abbreviations.11 4 Technical requirements and specifications.12 4.1 General requirements.12 4.1.1 Transmitter requirements.12 4.1.2 Receiver requirements.12 4.2 Presentation of equipment for testing purposes.12 4.2.1 Choice of model for testing.12 4.2.2 Testing of equipment with alternative power levels.12 4.2.3 Presentation of equipment that does not have an external RF connector (integral antenna equipment).13 4.2.3.1 Equipment with an internal permanent or temporary antenna connector.13 4.2.3.2 Equipment with a temporary antenna connector.13 4.2.3.3 Equipment intended to be implanted in a human body.13 4.3 Mechanical and electrical design.13 4.3.1 General.13 4.3.2 Controls.13 4.3.3 Transmitter shut-off facility.13 4.3.4 Marking.13 4.3.5 Equipment identification.13 4.4 Declarations by the Applicant.14 4.5 Auxiliary test equipment.14 4.6 Interpretation of the measurement results.14 5 Test conditions, power sources and ambient temperatures.14 5.1 Normal and extreme test conditions.14 5.2 Test power source.14 5.2.1 External test power source.14 5.2.2 Internal test power source.15 5.3 Normal test conditions.15 5.3.1 Normal temperature and humidity.15 5.3.2 Normal test power source.15 5.3.2.1 Mains voltage.15 5.3.2.2 Regulated lead-acid battery power sources.15 5.3.2.3 Other power sources.15 5.4 Extreme test conditions.16 5.4.1 Extreme temperatures.16 5.4.1.1 Procedure for tests at extreme temperatures.16 5.4.1.1.1 Procedure for equipment designed for continuous operation.16 5.4.1.1.2 Procedure for equipment designed for intermittent operation.16 5.4.1.2 Extreme temperature ranges.17 5.4.2 Extreme test source voltages.17 5.4.2.1 Mains voltage.17 5.4.2.2 Regulated lead-acid battery power sources.17 5.4.2.3 Power sources using other types of batteries.17 5.4.2.4 Other power sources.18 6 General conditions.18 SIST EN 301 839-1 V1.2.1:2007
ETSI ETSI EN 301 839-1 V1.2.1 (2007-07) 4
6.1 Normal test signals and test modulation.18 6.1.1 Normal modulation test signals for data.18 6.2 Antennas.18 6.3 Artificial antenna.18 6.3.1 Artificial antenna for transmitters with 50 Ω impedance connector.18 6.4 Test fixture for ULP-AMI-P.19 6.5 Test fixture for ULP-AMI.19 6.6 Test sites and general arrangements for radiated measurements.19 6.7 Modes of operation of the transmitter.19 6.8 Measuring receiver.20 7 Measurement uncertainty.20 8 Methods of measurement and limits for transmitter parameters.21 8A Introduction.21 8.1 Frequency error.21 8.1.1 Definition.22 8.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode.22 8.1.1.2 Method of measurement for systems with a modulated carrier frequency.22 8.1.2 Limit.22 8.2 Emission bandwidth measurement.23 8.2.1 Definition.23 8.2.1.1 Method of measurement.23 8.2.2 Limits.23 8.3 Effective radiated power of the fundamental emission.23 8.3.1 Definition.23 8.3.1.1 Methods of measurement.24 8.3.2 Limits.24 8.4 Spurious emissions.25 8.4.1 Definition.25 8.4.1.1 Method of measuring the effective radiated power of spurious emissions.25 8.4.2 Limits.26 8.5 Frequency stability under low voltage conditions.26 8.5.1 Definition.26 8.5.1.1 Method of measurement.26 8.5.2 Limits.27 8.6 ULP-AMI with restricted power and duty cycle.27 8.6.1 Definitions.27 8.6.2 Declaration of Duty Cycle.27 8.6.3 Limit for duty cycle and maximum number of transmissions.27 9 Methods of measurement and limits for receiver parameters.27 9.1 Spurious radiation.28 9.1.1 Definition.28 9.1.1.1 Method of measuring the effective radiated power of spurious radiations.28 9.1.2 Limits.29 10 Requirements and Measuring Methods for Monitoring Systems.29 10A Purpose.29 10B General Remarks on the Measurement Configuration.30 10.1 LBT threshold power level.30 10.1.1 Measurement method using out-of-operating-region disturbance.31 10.1.2 Measurement method using frequency administration commands.31 10.1.3 Results based on above test method.31 10.1.4 Limit.32 10.2 Monitoring system bandwidth.32 10.2.1 Measurement method using out-of-operating-region disturbance.32 10.2.2 Measurement method using frequency administration commands.33 10.2.3 Results based on above test method.33 10.3 Monitoring system scan cycle time and minimum channel monitoring period.33 10.3.1 Measurement method using out-of-operating-region disturbance.33 10.3.1.1 Scan cycle time.33 10.3.1.2 Minimum channel monitoring period.34 SIST EN 301 839-1 V1.2.1:2007
ETSI ETSI EN 301 839-1 V1.2.1 (2007-07) 5
10.3.2 Measurement method using frequency administration commands.34 10.3.3 Results based on above test method.34 10.3.3.1 Scan cycle time.34 10.3.3.2 Minimum Channel Monitoring Period.34 10.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, PTh.35 10.4.1 Access based on lowest ambient level above PTh using out-of-operating-region disturbance.35 10.4.2 Access based on lowest ambient level above PTh using frequency administration commands.35 10.4.3 Results based on above test method.36 10.5 Discontinuation of MICS session if a silent period greater than or equal to 5 s occurs.36 10.5.1 Measurement method.36 10.5.2 Results based on above test method.36 10.6 Use of pre-scanned alternate channel.36 10.6.1 Measurement method for alternate channel selection using out-of-operating-region disturbance.37 10.6.2 Measurement method for alternate channel selection using frequency administration commands.38 10.6.3 Results based on above test method.38 Annex A (normative): Radiated measurements.39 A.1 Test sites and general arrangements for measurements involving the use of radiated fields.39 A.1.1 Outdoor test site.39 A.1.1.1 Standard position.39 A.1.1.2 Equipment in close proximity to the human body but external to it.40 A.1.1.3 Human torso simulator for ULP-AMI.40 A.1.2 Test antenna.41 A.1.3 Substitution antenna.41 A.1.4 Optional additional indoor site.42 A.2 Guidance on the use of radiation test sites.43 A.2.1 Measuring distance.43 A.2.2 Test antenna.43 A.2.3 Substitution antenna.43 A.2.4 Artificial antenna.43 A.2.5 Auxiliary cables.43 A.3 Further optional alternative indoor test site using an anechoic chamber.44 A.3.1 Example of the construction of a shielded anechoic chamber.44 A.3.2 Influence of parasitic reflections in anechoic chambers.44 A.3.3 Calibration of the shielded RF anechoic chamber.45 Annex B (normative): Technical performance of the spectrum analyser.47 Annex C (informative): Strategy for ULP-AMI/ULP-AMI-P in the band 402 MHz to 405 MHz (source ERM_TG30 see URL: http://www.etsi.org/).48 Annex D (informative): Bibliography.49 History.50
SIST EN 301 839-1 V1.2.1:2007
ETSI ETSI EN 301 839-1 V1.2.1 (2007-07) 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 (http://webapp.etsi.org/IPR/home.asp). 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 European Standard (Telecommunications series) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). For non EU countries the present document may be used for regulatory purposes. The present document is part 1 of a multi-part deliverable covering Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz, as identified below: Part 1: "Technical characteristics and test methods"; Part 2: "Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive".
National transposition dates Date of adoption of this EN: 29 June 2007 Date of latest announcement of this EN (doa): 30 September 2007 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 March 2008 Date of withdrawal of any conflicting National Standard (dow): 31 March 2008
SIST EN 301 839-1 V1.2.1:2007
ETSI ETSI EN 301 839-1 V1.2.1 (2007-07) 7
Introduction ULP-AMI/ULP-AMI-P equipment in the MICS service is a unique new technology, available world wide in the medical field, that will provide high speed communications capability between individuals with AIMDs and medical practitioners engaged in utilizing these AIMDs for the purposes of diagnosing and delivering therapy to individuals with various illnesses. Equipment in the MICS service consists of active medical implants that communicate to other active medical implants and/or to ULP-AMI-P as e.g. external programmer/control transmitters. The present document includes methods of measurement for Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P), fitted with antenna connector and/or integral antenna. Equipment designed for use with an integral antenna may be supplied with a temporary or permanent internal connector for the purpose of testing, providing the characteristics being measured are not expected to be affected. If equipment, which is available on the market, is required to be checked it should be tested in accordance with the methods of measurement specified in the present document. Clauses 1 through 3 provide a general description on the types of equipment covered by the present document and the definitions, symbols and abbreviations used. Clause 4 provides a guide to requirements, the number of samples required in order that tests may be carried out and any markings on the equipment that the provider has to supply. Clauses 5 and 6 provide general test conditions to be used. Clause 7 gives the maximum measurement uncertainty values. Clauses 8, 9 and 10 specify spectrum utilization parameters and the measurement methods that are required for the protection of the spectrum and patient. Clause 10 describes channel access requirements and methods. In particular clause 10.1 describes the monitoring system performance specifications that have been chosen to minimize harmful interference to other equipment or services, reduce the potential for disturbance to this equipment from ambient sources or other medical device users in the band and provide a high degree of link reliability in the interest of the patient.
Annex A (normative) provides specifications concerning radiated measurements. Annex B (normative) provides specifications for test equipment. Annex C (informative) Strategy for ULP-AMI/ULP-AMI-P in the ba
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