ETSI EN 302 510-1 V1.1.1 (2007-07)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.WLYQHElectromagnetic compatibility and Radio spectrum Matters (ERM) - Radio equipment in the frequency range 30 MHz to 37,5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories - 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 302 510-1 Version 1.1.1SIST EN 302 510-1 V1.1.1:2007en01-december-2007SIST EN 302 510-1 V1.1.1:2007SLOVENSKI
STANDARD
ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 2
Reference DEN/ERM-TG30-003-1 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 302 510-1 V1.1.1:2007

ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 3
Contents Intellectual Property Rights.6 Foreword.6 1 Scope.7 2 References.7 3 Definitions, symbols and abbreviations.8 3.1 Definitions.8 3.2 Symbols.9 3.3 Abbreviations.9 4 Technical requirements and specifications.9 4.1 General requirements.9 4.1.1 Receiver classification.9 4.1.2 General performance criteria.10 4.2 Presentation of equipment for testing purposes.10 4.2.1 Choice of model for testing.10 4.2.2 Testing of equipment that does not have an external RF connector (integral antenna equipment).10 4.2.2.1 Equipment with an internal permanent or temporary antenna connector.11 4.2.2.2 Equipment with a temporary antenna connector.11 4.3 Mechanical and electrical design.11 4.3.1 General.11 4.3.2 Controls.11 4.3.3 Transmitter shut-off facility.11 4.3.4 Receiver power save capability.11 4.3.5 Marking (equipment identification).11 4.4 Auxiliary test equipment.11 4.5 Interpretation of the measurement results.12 5 Test conditions, power sources and ambient temperatures.12 5.1 Normal and extreme test conditions.12 5.2 Test power source.12 5.2.1 External test power source.12 5.2.2 Internal test power source.12 5.3 Normal test conditions.13 5.3.1 Normal temperature and humidity.13 5.3.2 Normal test power source.13 5.3.2.1 Mains voltage.13 5.3.2.2 Regulated lead-acid battery power sources.13 5.3.2.3 Other power sources.13 5.4 Extreme test conditions.13 5.4.1 Extreme temperatures.13 5.4.1.1 Procedure for tests at extreme temperatures.13 5.4.1.1.1 Procedure for equipment designed for continuous operation.14 5.4.1.1.2 Procedure for equipment designed for intermittent operation.14 5.4.1.2 Extreme temperature ranges.14 5.4.2 Extreme test source voltages.15 5.4.2.1 Mains voltage.15 5.4.2.2 Regulated lead-acid battery power sources.15 5.4.2.3 Power sources using other types of batteries.15 5.4.2.4 Other power sources.15 6 General conditions.16 6.1 Normal test signals and test modulation.16 6.1.1 Normal test signals for data.16 6.2 Antenna.16 6.2.1 Artificial Antenna.16 6.3 Test fixture.16 SIST EN 302 510-1 V1.1.1:2007

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6.3.1 Alternate test fixture for equipment adjacent to the body or intended to be implanted within a human body.17 6.4 Test sites and general arrangements for radiated measurements.17 6.5 Modes of operation of the transmitter.17 6.6 Measuring receiver.17 7 Transmitter requirements.18 7.1 Transmitter definitions.18 7.2 Maximum effective radiated power.18 7.2.1 Radiated E-field.18 7.2.2 Definition.18 7.2.3 Methods of measurement.18 7.2.4 Limits.19 7.3 Out of Band Emissions.19 7.3.1 Definition.20 7.3.2 Method of measurement.20 7.3.3 Limit.20 7.4 Unwanted Emissions in the spurious domain.20 7.4.1 Definition.20 7.4.2 Method of Measurement.20 7.4.3 Limit.21 7.5 Duty cycle.22 7.5.1 Definitions.22 7.5.2 Declaration.22 7.5.3 Duty cycle limit.22 8 Receiver requirement.22 8.1 Blocking or desensitization.22 8.1.1 Definition.22 8.1.2 Methods of measurement.22 8.1.3 Limits.23 8.2 Receiver spurious radiation.23 8.2.1 Definition.23 8.2.2 Methods of measurement.23 8.2.3 Limits.24 9 Measurement uncertainty.24 Annex A (normative): Radiated measurement.26 A.1 Test sites and general arrangements for measurements involving the use of radiated fields.26 A.1.1 Anechoic Chamber.26 A.1.2 Anechoic chamber with a conductive ground plane.27 A.1.3 Open Area Test Site (OATS).28 A.1.4 Human torso simulator for use with active medical implant membrane transmitters.29 A.1.5 Test antenna.31 A.1.6 Substitution antenna.31 A.1.7 Measuring antenna.31 A.1.8 Stripline arrangement.31 A.1.8.1 General.31 A.1.8.2 Description.31 A.1.8.3 Calibration.31 A.1.8.4 Mode of use.32 A.2 Guidance on the use of radiation test sites.32 A.2.1 Verification of the test site.32 A.2.2 Preparation of the EUT.32 A.2.3 Power supplies to the EUT.32 A.2.4 Range length.32 A.2.5 Site preparation.33 A.3 Standard test position.34 Annex B (normative): Technical performance of the spectrum analyser.35 SIST EN 302 510-1 V1.1.1:2007

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Annex C (informative): Bibliography.36 History.37
ETSI ETSI EN 302 510-1 V1.1.1 (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 (Type Approval) purposes. The present document is part 1 of a multi-part deliverable covering inductively coupled Ultra Low Power Active Medical Implant Membrane (ULP-AMI-M) devices in the frequency range 30 MHz to 37,5 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: 15 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
ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 7
1 Scope The present document applies to Ultra Low Power Active Medical membrane implant transmitters and receiver/activators operating in the range from 30 MHz to 37,5 MHz and any associated radio apparatus including patient related telecommunication devices using digital modulation techniques. An active implantable medical device (AIMD) is regulated under the AIMD Directive 90/385/EEC [4]: radio parts contained therein (referred to herein as ULP-AMI and ULP-AMI-P for peripheral devices) are regulated under the R&TTE Directive 1999/5/EC [5]. The present document applies to ULP-AMI equipment conforming to the following: - implantable membrane technology; - external equipment with an antenna connection and/or with an integral antenna; - for use as telecommunications and/or telecommand transmission to/from active medical membrane implant. The present document covers physician operated programmer/controller transmitters (typically fixed stations), patient operated external transmitters (fixed or mobile stations) and implanted radio transmitting devices (portable stations).
All types of membrane implant technology for radio devices are covered by the present document, provided the requirements of clause 7 are met. 2 References The following documents contain provisions which, through reference in this text, constitute provisions of the present document. • References are either specific (identified by date of publication and/or edition number or version number) or non-specific. • For a specific reference, subsequent revisions do not apply. • For a non-specific reference, the latest version applies. Referenced documents which are not found to be publicly available in the expected location might be found at http://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 validity. [1] ITU-T Recommendation O.153: "Basic parameters for the measurement of error performance at bit rates below the primary rate". [2] "Radiofrequency Radiation Dosimetry Handbook" (October 1986), USAF School of Aerospace Medicine, Aerospace Medical Division (AFSC), Brooks Air Force Base, TX 78235-5301. [3] ETSI TR 100 028 (V1.3.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM); Uncertainties in the measurement of mobile radio equipment characteristics". [4] Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (AMD Directive). [5] Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (R&TTE Directive). SIST EN 302 510-1 V1.1.1:2007

ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 8
3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the following terms and definitions apply: Active Implantable Medical Device (AIMD): any Active Medical Device (AMD) which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure Active Medical Device (AMD): any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity artificial antenna: reduced-radiating dummy load equal to the nominal impedance specified by the applicant blocking: a measure of the capability of the receiver to receive a wanted modulated signal without exceeding a given degradation due to the presence of an unwanted input signal at any frequencies other than those of the spurious responses in adjacent channels or bands NOTE:
See clause 8.1.1. conducted measurements: measurements which are made using a direct connection to the equipment under test custom antenna: antenna built according to manufacturers antenna design rules dedicated antenna: removable antenna supplied and tested with the radio equipment, designed as an indispensable part of the equipment duty cycle: ratio of the total on time of the "message" to the total off time in any one hour period under repeated normal operation during the time measurement interval NOTE: Whether the duty cycle is fixed or random depends on how the device is triggered. See clause 7.5.1. integral antenna: permanent fixed antenna, which may be built-in, that is designed as an indispensable part of the equipment medical implant membrane device (ULP-AMI-M): active medical implant device with resonant transmission capability that operates in a ULP-AMI band and is placed inside the human body for the purpose of performing diagnostic functions and/or delivery of therapeutic treatment medical implant membrane programmer/control transmitter: transmitter, operating outside of a human body in a ULP-AMI frequency band that transmits to and receives information from a membrane implant for the purpose of determining pressure within the human body out of band emissions: emissions resulting from the modulation process that are outside the declared band NOTE: See clause 7.3.1. programmer/controller: ULP-AMI-P equipment used by a physician to communicate with an implanted device radiated E-field: E-field in the direction of maximum field strength under the specified conditions of measurement NOTE:
See clause 7.2.2. radiated measurements: measurements which involve the absolute measurement of a radiated field spurious radiations from receivers: emissions radiated from the antenna, the chassis and case of the receiver NOTE:
It is specified as the radiated power of a discrete signal. Included in this definition are modulation products that are outside the 20 dB down point on either side of the fundamental emission. See clause 8.2.1. telecommand: use of radio communication for the transmission of signals to initiate, modify or terminate functions of equipment at a distance SIST EN 302 510-1 V1.1.1:2007

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telemetry: use of radio communication for indicating or recording data at a distance Ultra Low Power Active Medical Implant (ULP-AMI): radio part of an AIMD Ultra Low Power Active Medical Implant Peripheral (ULP-AMI-P) device: radio part of equipment outside the human body that communicates with an ULP-AMI unwanted emissions in the spurious domain: emissions at frequencies other than those of the carrier and sidebands associated with normal test modulation NOTE:
See clause 7.4.1. 3.2 Symbols For the purposes of the present document, the following symbols apply: E Electrical field strength f frequency P Power R Distance t time 3.3 Abbreviations For the purposes of the present document, the following abbreviations apply: AIMD
Active Implantable Medical Device AMD Active Medical Device EMC ElectroMagnetic Compatibility ERP Effective Radiated Power EUT
Equipment Under Test OATS Open Area Test Site R&TTE Radio and Telecommunications Terminal Equipment RF Radio Frequency RMS Root Mean Square SRD Short Range Device ULP-AMI Ultra Low Power Active Medical Implant ULP-AMI-M Ultra Low Power Active Medical Implant Membrane transmitter VSWR Voltage Standing Wave Ratio 4 Technical requirements and specifications 4.1 General requirements 4.1.1 Receiver classification The product family of ULP-AMI radio devices is divided into three receiver classes, see table 1, each having its own set of minimum performance criteria. This classification is based upon the impact on persons in case the equipment does not operate above the specified minimum performance level. Applicable equipment classification shall be specified by the manufacturer. SIST EN 302 510-1 V1.1.1:2007

ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 10 Table 1 Receiver class Relevant receiver clauses Risk assessment of receiver performance
8.1 Highly reliable ULP-AMI communication media; e.g. serving human life inherent systems (may result in a physical risk to a person)
8.1 Medium reliable ULP-AMI communication media e.g. when a failure to operate causes inconvenience to persons, which cannot simply be overcome by other means
8.1.1 Standard reliable ULP-AMI communication media e.g. when a failure to operate causes inconvenience to persons, which can simply be overcome by other means (e.g. manual) NOTE: In particular where an ULP-AMI-M which may have an inherent safety of human life implication, manufacturers and users should pay particular attention to the potential for interference from other systems operating in the same or adjacent bands.
4.1.2 General performance criteria For the purpose of the receiver performance tests, the receiver shall produce an appropriate output under normal conditions. Where the indicated performance cannot be achieved or if it is defined differently, the manufacturer shall declare and publish the performance criteria used to determine the performance of the receiver. 4.2 Presentation of equipment for testing purposes The applicant shall declare the operating frequency, the range of operating conditions and power requirements in consultation with the laboratory, as applicable, to establish the appropriate test conditions. Additionally, technical documentation and operating manuals, sufficient to make the test, shall be supplied. A test fixture for equipment with an integral antenna may be supplied by the applicant (see clauses 6.3). For equipment supplied with an external antenna the applicant shall provide the antenna and a suitable test fixture as needed. In general, compliance must be shown by performing radiated electric field strength measurements. 4.2.1 Choice of model for testing The applicant shall provide one or more samples of the equipment, as appropriate for testing. Stand alone equipment shall be offered by the applicant complete with any ancillary equipment needed for testing. If an equipment has several optional features, considered not to affect the RF parameters then the tests need only to be performed on the equipment configured with that combination of features considered to be the most complex, as proposed by the applicant and agreed by the test laboratory. In the case of integral or dedicated antenna equipment, if the equipment does not have an internal permanent 50 Ω connector then it is permissible to supply a second sample of the equipment with a temporary antenna connector fitted to facilitate testing, see clause 4.2.2. 4.2.2 Testing of equipment that does not have an external RF connector (integral antenna equipment) This type of equipment will normally be tested by performing radiated tests at 3 meters. For devices with very low radiated field levels, measurements may be made at closer distance and the levels extrapolated to 3 meters using an inverse linear extrapolation rate. SIST EN 302 510-1 V1.1.1:2007

ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 11 4.2.2.1 Equipment with an internal permanent or temporary antenna connector The means to access and/or implement the internal permanent or temporary antenna connector shall be stated by the applicant with the aid of a diagram. The fact that use has been made of the internal antenna connection, or of a temporary connection, to facilitate measurements shall be recorded in the test report. 4.2.2.2 Equipment with a temporary antenna connector The applicant may submit one set of equipment with the normal antenna connected, to enable radiated measurements to be made. The applicant shall attend the test laboratory at the conclusion of the radiated measurements, to disconnect the antenna and fit the temporary connector if needed. The testing laboratory staff shall not connect or disconnect any temporary antenna connector. Alternatively, the applicant may submit two sets of equipment to the test laboratory, one fitted with a temporary antenna connector with the antenna disconnected and another with the antenna connected. Each equipment shall be used for the appropriate tests. The applicant shall declare that the two sets of equipment are identical in all aspects except for the antenna connector. 4.3 Mechanical and electrical design 4.3.1 General The equipment submitted by the applicant should be designed, constructed and manufactured in accordance with sound engineering practice and with the aim of minimizing harmful interference to other equipment and services. Transmitters and receivers may be individual or combination units. 4.3.2 Controls Those controls which, if maladjusted, might increase the interfering potentialities of the equipment shall not be easily accessible to the user. 4.3.3 Transmitter shut-off facility If the transmitter is equipped with an automatic transmitter shut-off facility, it should be made inoperative for the duration of the test. 4.3.4 Receiver power save capability If the receiver is equipped with a battery-saving circuit, this circuit should be made inoperative for the duration of the tests. 4.3.5 Marking (equipment identification) The equipment shall be marked in a visible place. This marking shall be legible and durable. Where this is not possible due to physical size restrictions or factors associated with the intended functioning of the device, the marking shall be included in the user's manual. AIMD may also have a unique electronic identification that prevents unauthorized access to the telecommand and telemetry functions of the ULP-AMI. 4.4 Auxiliary test equipment All necessary test signal sources, test fixtures, specialized test apparatus and set-up information shall accompany the equipment when it is submitted for testing unless alternative arrangements are agreed to by the test house and the manufacturer. SIST EN 302 510-1 V1.1.1:2007

ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 12 4.5 Interpretation of the measurement results Each equipment submitted for testing shall fulfil the requirements of the present document on all frequencies over which it is intended to operate. The interpretation of the results recorded on the appropriate test report for the measurements described in the present document shall be as specified in clause 9. 5 Test conditions, power sources and ambient temperatures 5.1 Normal and extreme test conditions Testing shall be made under normal test conditions, and also, where stated, under extreme test conditions. It should be noted that emissions test on active medical implant membrane systems may at the option of the manufacturer be performed using the human torso simulator (artificial) filled with the tissue substitute material at nominal room temperature or in situ (using a human volunteer). The purpose is to facilitate testing at the measurement facility in a manner that simulates the intended usage in the manner the equipment is specified by the manufacturer to be used. Measured emission levels are not expected to vary significantly from the levels measured at the nominal temperature and the normal body temperature of 37°C. The test conditions and procedures shall be as specified in clauses 5.2 to 5.4. 5.2 Test power source The equipment shall be tested using the appropriate test power source provided by the manufacturer as specified in clauses 5.2.1 or 5.2.2. Where equipment can be powered using either external or internal power sources, then the equipment shall be tested using the external power source as specified in clause 5.2.1 then repeated using the internal power source as specified in clause 5.2.2. The test power source used shall be stated in the test report. 5.2.1 External test power source During tests, the power source of the equipment shall be replaced by an external test power source capable of producing normal and extreme test voltages as specified in clauses 5.3.2 and 5.4.2. The internal impedance of the external test power source shall be low enough for its effect on the test results to be negligible. For the purpose of the tests, the voltage of the external test power source shall be measured at the input terminals of the equipment. The external test power source shall be suitably de-coupled as close to the equipment battery terminals as practicable. For radiated measurements any external power leads should be so arranged so as not to affect the measurements. During tests the test power source voltages shall be within a tolerance of < ±1 % relative to the voltage at the beginning of each test. The value of this tolerance can be critical for certain measurements. Using a smaller tolerance will provide a better uncertainty value for these measurements. 5.2.2 Internal test power source For radiated measurements on portable equipment with integral antenna, fully charged internal batteries should be used. The batteries used should be as supplied or recommended by the applicant. If internal batteries are used, at the end of each test the voltage shall be within a tolerance of < ±5 % relative to the voltage at the beginning of each test. For portable devices where the batteries cannot be measured or replaced but have telemetry readout of battery voltage, it is acceptable to record the starting and ending voltages as provided by the telemetry readout. This shall be stated in the test report. If appropriate, for conducted measurements or where a test fixture is used, an external power supply at the required voltage may replace the supplied or recommended internal batteries. This shall be stated on the test report. SIST EN 302 510-1 V1.1.1:2007

ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 13 Equipment intended to be implanted in a human body may be hermetically sealed or packaged in a manner where it may not be possible to measure the battery or other voltage source directly or indirectly. For this type of equipment, it is not necessary to measure the voltage; however, care shall be taken to ensure that the internal power supply voltage does not fall below the manufacturer's specification for normal operating voltage range. 5.3 Normal test conditions 5.3.1 Normal temperature and humidity The normal temperature and humidity conditions for tests for devices external to the human body shall be any convenient combination of temperature and humidity within the following ranges: - temperature +15°C to +37°C; - relative humidity 20 % to 75 %. Active medical implant transmitters operate after implant in a human body. Accordingly, the body tends to serve as an oven to maintain the implant temperature near 37°C. Therefore, the normal temperature and humidity conditions for implant transmitters shall be within the following ranges: - temperature +36°C to +38°C; - relative humidity not applicable. When it is impracticable to carry out tests under these conditions, a note to this effect, stating the ambient temperature and relative humidity during the tests, shall be added to the test report. 5.3.2 Normal test power source 5.3.2.1 Mains voltage The normal test voltage for equipment to be connected to the mains shall be the nominal mains voltage. For the purpose of the present document, the nominal voltage shall be the declared voltage, or any of the declared voltages, for which the equipment was designed. The frequency of the test power source corresponding to the ac mains shall be between 49 Hz and 51 Hz. 5.3.2.2 Regulated lead-acid battery power sources When any peripheral device or radio equipment that is part of a membrane implant system is intended for operation with the usual types of regulated lead-acid battery power sources, the normal test voltage shall be 1,1 multiplied by the nominal voltage of the battery (e.g. 6 V, 12 V etc.). 5.3.2.3 Other power sources For operation from other power sources or types of battery (primary or secondary), the normal test voltage shall be that declared by the equipment applicant and agreed by the test laboratory. Such values shall be stated in the test report. 5.4 Extreme test conditions 5.4.1 Extreme temperatures 5.4.1.1 Procedure for tests at extreme temperatures Before measurements are made the equipment shall have reached thermal balance in the test chamber. The equipment shall be switched off during the temperature stabilizing period. SIST EN 302 510-1 V1.1.1:2007

ETSI ETSI EN 302 510-1 V1.1.1 (2007-07) 14 In the case of equipment containing temperature stabilization circuits designed to operate continuously, the temperature stabilization circuits shall be switched on for 15 minutes after thermal balance has been obtained, and the equipment shall then meet the specified requirements.
If the thermal balance is not checked by measurements, a temperature stabilizing period of at least one hour, or such period as may be decided by the test laboratory, shall be allowed. The sequence of measurements shall be chosen, and the humidity content in the test chamber shall be controlled so that excessive condensation does not occur. If the equipment is incapable of transmitting an unmodulated carrier, an actual digital data sequence or a pseudorandom sequence representative of an actual digital data transmission shall be used to modulate the carrier (see clauses 6.1 and 6.1.1). 5.4.1.1.1 Procedure for equipment designed for continuous operation If the applicant states that the equipment is designed for continuous operation, the test procedure shall be as follows: - before conducting tests at the upper extreme temperature the equipment shall be placed in the test chamber and left until thermal balance is attained. The equipment shall then be switched on in the transmit condition for a period of time specified by the manufacturer to be the maximum time the equipment will transmit in normal operation after which the equipment shall meet the specified requirements; - for tests at the lower extreme temperature, the equipment shall be left in the test chamber until thermal balance is attained, then switched on for a period of one minute after which the equipment shall meet the specified requirements. 5.4.1.1.2 Procedure for equipment designed for intermittent operation If the applicant states that the equipment is designed for intermittent operation, the test procedure shall be as follows: - before tests at the upper extreme temperature the equipment shall be placed in the test chamber and left until thermal balance is attained in the oven. The equipment shall then either: - transmit on and off according to the applicants declared duty cycle for a period of five minutes; or - if the applicant's declared on period exceeds one minute, then transmit in the on condition for a period not exceeding one minute, followed by a period in the
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