SIST EN 301 839-1 V1.1.1:2003
(Main)Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical characteristics, including electromagnetic compatibility requirements, and test methods
Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical characteristics, including electromagnetic compatibility requirements, and test methods
To add this piece of standard to the EN 300 220-1 Rev1 and to support CEPT/ERC Rec 1 and to support CEPT/ERC Rec 70-03 Annex 12. Technical characteristics and test methods for Ultra Low Power Active medical implants.
Elektromagnetna združljivost (EMC) in zadeve v zvezi z radijskim spektrom (ERM) - Radijska oprema v frekvenčnem območju od 402 MHz do 405 MHz za aktivne medicinske implantate in pribor ultra majhnih moči - 1. del: Tehnične karakteristike, vključno z zahtevami elektromagnetne združljivosti in s preskuševalnimi metodami
General Information
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.WLYQHLþQHElectromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical characteristics, including electromagnetic compatibility requirements, and test methods33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in generalICS:Ta slovenski standard je istoveten z:EN 301 839-1 Version 1.1.1SIST EN 301 839-1 V1.1.1:2003en01-april-2003SIST EN 301 839-1 V1.1.1:2003SLOVENSKI
STANDARD
SIST EN 301 839-1 V1.1.1:2003
ETSI EN 301 839-1 V1.1.1 (2002-06)European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Radio equipment in the frequency range 402 MHz to 405 MHzfor Ultra Low Power Active Medical Implants and Accessories;Part 1: Technical characteristics, includingelectromagnetic compatibility requirements, and test methods
SIST EN 301 839-1 V1.1.1:2003
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 2
Reference REN/ERM-RP08-0404-1 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, send your comment to: editor@etsi.fr 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 2002. 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 V1.1.1:2003
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 3
Contents Intellectual Property Rights.6 Foreword.6 Introduction.7 1 Scope.8 2 References.9 3 Definitions, symbols and abbreviations.10 3.1 Definitions.10 3.2 Symbols.12 3.3 Abbreviations.12 4 Overview of technical requirement specifications.12 4.1 Essential 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.13 4.2.2 Testing of equipment with alternative power levels.13 4.2.3 Testing of equipment that does not have an external 50
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.14 4.3.1 General.14 4.3.2 Controls.14 4.3.3 Transmitter shut-off facility.14 4.3.4 Marking (equipment identification).14 4.3.4.1 Equipment identification.14 4.3.4.2 Regulatory marking.14 4.4 Declarations by the applicant.14 4.5 Auxiliary test equipment.14 4.6 Interpretation of the measurement results.15 5 Test conditions, power sources and ambient temperatures.15 5.1 Normal and extreme test conditions.15 5.2 Test power source.15 5.2.1 External test power source.15 5.2.2 Internal test power source.16 5.3 Normal test conditions.16 5.3.1 Normal temperature and humidity.16 5.3.2 Normal test power source.16 5.3.2.1 Mains voltage.16 5.3.2.2 Regulated lead-acid battery power sources.16 5.3.2.3 Other power sources.16 5.4 Extreme test conditions.17 5.4.1 Extreme temperatures.17 5.4.1.1 Procedure for tests at extreme temperatures.17 5.4.1.1.1 Procedure for equipment designed for continuous operation.17 5.4.1.1.2 Procedure for equipment designed for intermittent operation.17 5.4.1.2 Extreme temperature ranges.18 5.4.2 Extreme test source voltages.18 5.4.2.1 Mains voltage.18 5.4.2.2 Regulated lead-acid battery power sources.18 5.4.2.3 Power sources using other types of batteries.18 5.4.2.4 Other power sources.19 SIST EN 301 839-1 V1.1.1:2003
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 4
6 General conditions.19 6.1 Normal test signals and test modulation.19 6.1.1 Normal modulation test signals for data.19 6.2 Antennas.19 6.3 Artificial antenna.19 6.3.1 Artificial antenna for transmitters with 50 Ω impedance connector.19 6.4 Test fixture for non-implanted equipment.20 6.5 Test fixture for equipment intended to be implanted in a human body.20 6.6 Test sites and general arrangements for radiated measurements.20 6.7 Modes of operation of the transmitter.21 6.8 Measuring receiver.21 7 Measurement uncertainty.21 8 Methods of measurement and limits for transmitter parameters.22 8.1 Frequency error.22 8.1.1 Definition.22 8.1.1.1 Systems with an unmodulated carrier frequency operating mode.22 8.1.1.1.1 Method of measurement.22 8.1.1.2 Systems with a modulated carrier frequency.23 8.1.1.2.1 Method of measurement.23 8.1.2 Limit.23 8.2 Emission bandwidth measurement.23 8.2.1 Definition.23 8.2.1.1 Method of measurement.23 8.2.2 Limits.24 8.3 Effective radiated power of the fundamental emission.24 8.3.1 Definition.24 8.3.1.1 Methods of measurement.24 8.3.2 Limits.25 8.4 Spurious emissions.25 8.4.1 Definition.26 8.4.1.1 Method of measuring the effective radiated power of spurious emissions.26 8.4.2 Limits.27 8.5 Frequency stability under low voltage conditions.27 8.5.1 Definition.27 8.5.1.1 Method of measurement.27 8.5.2 Limits.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 emissions.28 9.1.2 Limits.29 10 Methods of measuring and requirements for monitoring systems.29 10.1 Monitoring system threshold power level.30 10.1.1 Measurement procedure using out-of-operating-region disturbance.30 10.1.2 Measurement procedure using frequency administration commands.31 10.1.3 Results based on above test procedure.31 10.2 Monitoring system bandwidth.31 10.2.1 Measurement procedure using out-of-operating-region disturbance.32 10.2.2 Measurement procedure using frequency administration commands.32 10.2.3 Results based on above test procedure.32 10.3 Monitoring system scan cycle time and minimum channel monitoring period.33 10.3.1 Measurement procedure using out-of-operating-region disturbance.33 10.3.1.1 Scan cycle time.33 10.3.1.2 Minimum channel monitoring period.33 10.3.2 Measurement procedure using frequency administration commands.33 10.3.3 Results based on above test procedure.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 threshold level, Thp.34 SIST EN 301 839-1 V1.1.1:2003
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10.4.1 Access based on lowest ambient level above Thp using out-of-operating-region disturbance.34 10.4.2 Access based on lowest ambient level above Thp using frequency administration commands.35 10.4.3 Results based on above test procedure.35 10.5 Discontinuation of MICS session if a silent period greater than or equal to 5 s occurs.35 10.5.1 Measurement procedure.35 10.5.2 Results based on above test procedure.36 10.6 Use of pre-scanned alternate channel.36 10.6.1 Measurement procedure for alternate channel selection using out-of-operating-region disturbance.36 10.6.2 Measurement procedure for alternate channel selection using frequency administration commands.37 10.6.3 Results based on above test procedure.37 11 Safety issues related to non-ionizing radiation.38 12 Electromagnetic compatibility.38 12.1 Method of measurement for electromagnetic compatibility.39 12.1.1 Programmer/Controller.39 12.1.2 Active implantable medical device.39 12.2 Requirements.40 12.2.1 Programmer/controller.40 12.2.2 Active implantable medical device.40 Annex A (normative): Radiated measurements.41 A.1 Test sites and general arrangements for measurements involving the use of radiated fields.41 A.1.1 Outdoor test site.41 A.1.1.1 Standard position.41 A.1.1.2 Equipment in close proximity to the human body but external to it.42 A.1.1.3 Active medical implant equipment.42 A.1.2 Test antenna.43 A.1.3 Substitution antenna.43 A.1.4 Optional additional indoor site.44 A.2 Guidance on the use of radiation test sites.45 A.2.1 Measuring distance.45 A.2.2 Test antenna.45 A.2.3 Substitution antenna.45 A.2.4 Artificial antenna.45 A.2.5 Auxiliary cables.45 A.3 Further optional alternative indoor test site using an anechoic chamber.46 A.3.1 Example of the construction of a shielded anechoic chamber.46 A.3.2 Influence of parasitic reflections in anechoic chambers.46 A.3.3 Calibration of the shielded RF anechoic chamber.47 Annex B (normative): Technical performance of the spectrum analyser.49 Annex C (informative): Bibliography.50 History.51
SIST EN 301 839-1 V1.1.1:2003
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 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). The present document is part 1 of a multi-part deliverable covering Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories, as identified below: Part 1: "Technical characteristics, including electromagnetic compatibility requirements, 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: 7 June 2002 Date of latest announcement of this EN (doa): 30 September 2002 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 March 2003 Date of withdrawal of any conflicting National Standard (dow): 31 March 2003
SIST EN 301 839-1 V1.1.1:2003
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 7
Introduction The present document is drafted on the assumption that type test measurements, performed in an accredited test laboratory will be accepted by the various National Regulatory authorities in order to grant type approval, provided the National Regulatory requirements are met. This is in compliance with CEPT/ERC/REC 01-06E [2]. Included are methods of measurement for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories, 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 and abbreviations used. Clause 4 provides a guide to essential requirements, the number of samples required in order that type tests may be carried out and any markings on the equipment that the applicant has to provide. Clauses 5 and 6 provide general test conditions to be used. Clause 7 gives the maximum measurement uncertainty values. Clauses 8, 9, 10 and 11 specify the spectrum utilization and safety parameters that are required to be determined for the protection of the public. They contain the maximum limits and monitoring system performance specifications that have been chosen to minimize harmful disturbance to other equipment or services, reduce the potential for disturbance to this equipment from ambient sources, and protect the public. The clauses provide details on how the equipment should be tested and the conditions that should be applied. Clause 12 specifies the electromagnetic compatibility testing and measurement requirements for insuring the health and safety of the users of active medical implants and accessories are protected. Annex A provides normative specifications concerning radiated measurements. Annex B provides normative specifications for test equipment.
SIST EN 301 839-1 V1.1.1:2003
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06)
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