ETSI EN 301 839-1 V1.3.1 (2009-10)

ETSI EN 301 839-1 V1.3.1 (2009-10)
European Standard (Telecommunications series)

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

---------------------- Page: 1 ----------------------
2 ETSI EN 301 839-1 V1.3.1 (2009-10)



Reference
REN/ERM-TG30-263-1
Keywords
radio, SRD, testing
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 à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88

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 2009.
All rights reserved.

TM TM TM TM
DECT , PLUGTESTS , UMTS , TIPHON , the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered
for the benefit of its Members.
TM
3GPP is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners.
LTE™ is a Trade Mark of ETSI currently being registered
for the benefit of its Members and of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI

---------------------- Page: 2 ----------------------
3 ETSI EN 301 839-1 V1.3.1 (2009-10)
Contents
Intellectual Property Rights . 6
Foreword . 6
Introduction . 6
1 Scope . 8
2 References . 8
2.1 Normative references . 9
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 10
3.1 Definitions . 10
3.2 Symbols . 12
3.3 Abbreviations . 12
4 Technical requirements and specifications . 13
4.1 General requirements . 13
4.1.1 Transmitter requirements . 13
4.1.2 Receiver requirements . 13
4.2 Presentation of equipment for testing purposes . 13
4.2.1 Choice of model for testing . 13
4.2.2 Testing of equipment with alternative power levels . 13
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 . 14
4.2.3.3 Equipment intended to be implanted in a human body . 14
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 . 14
4.3.5 Equipment identification . 14
4.4 Declarations by the Applicant . 14
4.5 Auxiliary test equipment . 15
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
ETSI

---------------------- Page: 3 ----------------------
4 ETSI EN 301 839-1 V1.3.1 (2009-10)
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 . 20
6.4 Test fixture for ULP-AMI-P . 20
6.5 Test fixture for ULP-AMI . 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 . 22
8 Methods of measurement and limits for transmitter parameters . 22
8.1 Frequency error . 23
8.1.1 Definition . 23
8.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 23
8.1.1.2 Method of measurement for systems with a modulated carrier frequency . 23
8.1.2 Limit . 24
8.2 Emission bandwidth measurement . 24
8.2.1 Definition . 24
8.2.1.1 Method of measurement . 24
8.2.2 Limits . 25
8.3 Effective radiated power of the fundamental emission . 25
8.3.1 Definition . 25
8.3.1.1 Methods of measurement . 25
8.3.2 Limits . 26
8.4 Spurious domain emissions . 26
8.4.1 Definition . 26
8.4.1.1 Method of measuring the effective radiated power of spurious domain emissions . 26
8.4.2 Limits . 28
8.5 Frequency stability under low voltage conditions . 28
8.5.1 Definition . 28
8.5.1.1 Method of measurement . 28
8.5.2 Limits . 28
8.6 ULP-AMI with restricted power and duty cycle . 28
8.6.1 Definitions . 28
8.6.2 Declaration of Duty Cycle . 28
8.6.3 Limit for duty cycle and maximum number of transmissions . 29
9 Methods of measurement and limits for receiver parameters . 29
9.1 Spurious domain radiation . 29
9.1.1 Definition . 29
9.1.1.1 Method of measuring the effective radiated power of spurious domain radiations . 29
9.1.2 Limits . 31
10 Requirements and Measuring Methods for Monitoring Systems . 31
10A Purpose . 31
10B General Remarks on the Measurement Configuration . 31
10.1 LBT threshold power level . 32
10.1.1 Measurement method using out-of-operating-region disturbance . 33
10.1.2 Measurement method using frequency administration commands . 33
10.1.3 Results based on above test method . 33
10.1.4 Limit . 34
10.2 Monitoring system bandwidth . 34
10.2.1 Measurement method using out-of-operating-region disturbance . 34
10.2.2 Measurement method using frequency administration commands . 35
10.2.3 Results based on above test method . 35
10.3 Monitoring system scan cycle time and minimum channel monitoring period . 35
10.3.1 Measurement method using out-of-operating-region disturbance . 35
10.3.1.1 Scan cycle time . 35
10.3.1.2 Minimum channel monitoring period . 36
ETSI

---------------------- Page: 4 ----------------------
5 ETSI EN 301 839-1 V1.3.1 (2009-10)
10.3.2 Measurement method using frequency administration commands . 36
10.3.3 Results based on above test method . 36
10.3.3.1 Scan cycle time . 36
10.3.3.2 Minimum Channel Monitoring Period . 36
10.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, P . 37
Th
10.4.1 Access based on lowest ambient level above P using out-of-operating-region disturbance . 37
Th
10.4.2 Access based on lowest ambient level above P using frequency administration commands . 37
Th
10.4.3 Results based on above test method . 38
10.5 Discontinuation of MICS session if a silent period greater than or equal to 5 seconds occurs . 38
10.5.1 Measurement method . 38
10.5.2 Results based on above test method . 38
10.6 Use of pre-scanned alternative channel . 38
10.6.1 Measurement method for alternate channel selection using out-of-operating-region disturbance . 39
10.6.2 Measurement method for alternate channel selection using frequency administration commands . 40
10.6.3 Results based on above test method . 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 Human torso simulator for ULP-AMI . 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): Strategy for ULP-AMI/ULP-AMI-P in the band 402 MHz to
405 MHz (source ERM_TG30 see URL: http://www.etsi.org/) . 50
Annex D (informative): Bibliography . 51
History . 52

ETSI

---------------------- Page: 5 ----------------------
6 ETSI EN 301 839-1 V1.3.1 (2009-10)
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: 28 September 2009
Date of latest announcement of this EN (doa): 31 December 2009
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 30 June 2010
Date of withdrawal of any conflicting National Standard (dow): 30 June 2010

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.
ETSI

---------------------- Page: 6 ----------------------
7 ETSI EN 301 839-1 V1.3.1 (2009-10)
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 conc
...

Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
European Standard (Telecommunications series)

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

---------------------- Page: 1 ----------------------
2 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)



Reference
REN/ERM-TG30-263-1
Keywords
radio, SRD, testing
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 à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88

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 2009.
All rights reserved.

TM TM TM TM
DECT , PLUGTESTS , UMTS , TIPHON , the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered
for the benefit of its Members.
TM
3GPP is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners.
LTE™ is a Trade Mark of ETSI currently being registered
for the benefit of its Members and of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI

---------------------- Page: 2 ----------------------
3 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
Contents
Intellectual Property Rights . 6
Foreword . 6
Introduction . 6
1 Scope . 8
2 References . 8
2.1 Normative references . 9
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 10
3.1 Definitions . 10
3.2 Symbols . 12
3.3 Abbreviations . 12
4 Technical requirements and specifications . 13
4.1 General requirements . 13
4.1.1 Transmitter requirements . 13
4.1.2 Receiver requirements . 13
4.2 Presentation of equipment for testing purposes . 13
4.2.1 Choice of model for testing . 13
4.2.2 Testing of equipment with alternative power levels . 13
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 . 14
4.2.3.3 Equipment intended to be implanted in a human body . 14
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 . 14
4.3.5 Equipment identification . 14
4.4 Declarations by the Applicant . 14
4.5 Auxiliary test equipment . 15
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
ETSI

---------------------- Page: 3 ----------------------
4 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
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 . 20
6.4 Test fixture for ULP-AMI-P . 20
6.5 Test fixture for ULP-AMI . 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 . 22
8 Methods of measurement and limits for transmitter parameters . 22
8.1 Frequency error . 23
8.1.1 Definition . 23
8.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 23
8.1.1.2 Method of measurement for systems with a modulated carrier frequency . 23
8.1.2 Limit . 24
8.2 Emission bandwidth measurement . 24
8.2.1 Definition . 24
8.2.1.1 Method of measurement . 24
8.2.2 Limits . 25
8.3 Effective radiated power of the fundamental emission . 25
8.3.1 Definition . 25
8.3.1.1 Methods of measurement . 25
8.3.2 Limits . 26
8.4 Spurious domain emissions . 26
8.4.1 Definition . 26
8.4.1.1 Method of measuring the effective radiated power of spurious domain emissions . 26
8.4.2 Limits . 28
8.5 Frequency stability under low voltage conditions . 28
8.5.1 Definition . 28
8.5.1.1 Method of measurement . 28
8.5.2 Limits . 28
8.6 ULP-AMI with restricted power and duty cycle . 28
8.6.1 Definitions . 28
8.6.2 Declaration of Duty Cycle . 28
8.6.3 Limit for duty cycle and maximum number of transmissions . 29
9 Methods of measurement and limits for receiver parameters . 29
9.1 Spurious domain radiation . 29
9.1.1 Definition . 29
9.1.1.1 Method of measuring the effective radiated power of spurious domain radiations . 29
9.1.2 Limits . 31
10 Requirements and Measuring Methods for Monitoring Systems . 31
10A Purpose . 31
10B General Remarks on the Measurement Configuration . 31
10.1 LBT threshold power level . 32
10.1.1 Measurement method using out-of-operating-region disturbance . 33
10.1.2 Measurement method using frequency administration commands . 33
10.1.3 Results based on above test method . 33
10.1.4 Limit . 34
10.2 Monitoring system bandwidth . 34
10.2.1 Measurement method using out-of-operating-region disturbance . 34
10.2.2 Measurement method using frequency administration commands . 35
10.2.3 Results based on above test method . 35
10.3 Monitoring system scan cycle time and minimum channel monitoring period . 35
10.3.1 Measurement method using out-of-operating-region disturbance . 35
10.3.1.1 Scan cycle time . 35
10.3.1.2 Minimum channel monitoring period . 36
ETSI

---------------------- Page: 4 ----------------------
5 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
10.3.2 Measurement method using frequency administration commands . 36
10.3.3 Results based on above test method . 36
10.3.3.1 Scan cycle time . 36
10.3.3.2 Minimum Channel Monitoring Period . 36
10.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, P . 37
Th
10.4.1 Access based on lowest ambient level above P using out-of-operating-region disturbance . 37
Th
10.4.2 Access based on lowest ambient level above P using frequency administration commands . 37
Th
10.4.3 Results based on above test method . 38
10.5 Discontinuation of MICS session if a silent period greater than or equal to 5 seconds occurs . 38
10.5.1 Measurement method . 38
10.5.2 Results based on above test method . 38
10.6 Use of pre-scanned alternative channel . 38
10.6.1 Measurement method for alternate channel selection using out-of-operating-region disturbance . 39
10.6.2 Measurement method for alternate channel selection using frequency administration commands . 40
10.6.3 Results based on above test method . 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 Human torso simulator for ULP-AMI . 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): Strategy for ULP-AMI/ULP-AMI-P in the band 402 MHz to
405 MHz (source ERM_TG30 see URL: http://www.etsi.org/) . 50
Annex D (informative): Bibliography . 51
History . 52

ETSI

---------------------- Page: 5 ----------------------
6 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
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), and is now submitted for the Vote phase of the
ETSI standards Two-step Approval Procedure.
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".

Proposed national transposition dates
Date of latest announcement of this EN (doa): 3 months after ETSI publication
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 6 months after doa
Date of withdrawal of any conflicting National Standard (dow): 6 months after doa

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.
ETSI

---------------------- Page: 6 ----------------------
7 Final draft ETSI EN 301 839-1 V1.3.1 (2009-07)
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 ot
...

Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
European Standard (Telecommunications series)

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

---------------------- Page: 1 ----------------------
2 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)



Reference
REN/ERM-TG30-263-1
Keywords
radio, SRD, testing
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 à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88

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© European Telecommunications Standards Institute 2009.
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ETSI

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3 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
Contents
Intellectual Property Rights . 6
Foreword . 6
Introduction . 6
1 Scope . 8
2 References . 8
2.1 Normative references . 9
2.2 Informative references . 9
3 Definitions, symbols and abbreviations . 10
3.1 Definitions . 10
3.2 Symbols . 12
3.3 Abbreviations . 12
4 Technical requirements and specifications . 13
4.1 General requirements . 13
4.1.1 Transmitter requirements . 13
4.1.2 Receiver requirements . 13
4.2 Presentation of equipment for testing purposes . 13
4.2.1 Choice of model for testing . 13
4.2.2 Testing of equipment with alternative power levels . 13
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 . 14
4.2.3.3 Equipment intended to be implanted in a human body . 14
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 . 14
4.3.5 Equipment identification . 14
4.4 Declarations by the Applicant . 14
4.5 Auxiliary test equipment . 15
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
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4 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
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 . 20
6.4 Test fixture for ULP-AMI-P . 20
6.5 Test fixture for ULP-AMI . 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
8A Introduction . 22
8.1 Frequency error . 22
8.1.1 Definition . 23
8.1.1.1 Method of measurement for systems with an unmodulated carrier frequency operating mode . 23
8.1.1.2 Method of measurement for systems with a modulated carrier frequency . 23
8.1.2 Limit . 23
8.2 Emission bandwidth measurement . 24
8.2.1 Definition . 24
8.2.1.1 Method of measurement . 24
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 . 25
8.3.2 Limits . 26
8.4 Spurious emissions . 26
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 . 28
8.5.2 Limits . 28
8.6 ULP-AMI with restricted power and duty cycle . 28
8.6.1 Definitions . 28
8.6.2 Declaration of Duty Cycle . 28
8.6.3 Limit for duty cycle and maximum number of transmissions . 28
9 Methods of measurement and limits for receiver parameters . 28
9.1 Spurious radiation. 29
9.1.1 Definition . 29
9.1.1.1 Method of measuring the effective radiated power of spurious radiations. 29
9.1.2 Limits . 30
10 Requirements and Measuring Methods for Monitoring Systems . 30
10A Purpose . 30
10B General Remarks on the Measurement Configuration . 31
10.1 LBT threshold power level . 31
10.1.1 Measurement method using out-of-operating-region disturbance . 32
10.1.2 Measurement method using frequency administration commands . 32
10.1.3 Results based on above test method . 32
10.1.4 Limit . 33
10.2 Monitoring system bandwidth . 33
10.2.1 Measurement method using out-of-operating-region disturbance . 33
10.2.2 Measurement method using frequency administration commands . 34
10.2.3 Results based on above test method . 34
10.3 Monitoring system scan cycle time and minimum channel monitoring period . 34
10.3.1 Measurement method using out-of-operating-region disturbance . 34
10.3.1.1 Scan cycle time . 34
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5 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
10.3.1.2 Minimum channel monitoring period . 35
10.3.2 Measurement method using frequency administration commands . 35
10.3.3 Results based on above test method . 35
10.3.3.1 Scan cycle time . 35
10.3.3.2 Minimum Channel Monitoring Period . 35
10.4 Channel access based on ambient levels relative to the calculated access LBT threshold level, P . 36
Th
10.4.1 Access based on lowest ambient level above P using out-of-operating-region disturbance . 36
Th
10.4.2 Access based on lowest ambient level above P using frequency administration commands . 36
Th
10.4.3 Results based on above test method . 37
10.5 Discontinuation of MICS session if a silent period greater than or equal to 5 s occurs . 37
10.5.1 Measurement method . 37
10.5.2 Results based on above test method . 37
10.6 Use of pre-scanned alternate channel . 37
10.6.1 Measurement method for alternate channel selection using out-of-operating-region disturbance . 38
10.6.2 Measurement method for alternate channel selection using frequency administration commands . 39
10.6.3 Results based on above test method . 39
Annex A (normative): Radiated measurements . 40
A.1 Test sites and general arrangements for measurements involving the use of radiated fields . 40
A.1.1 Outdoor test site . 40
A.1.1.1 Standard position . 40
A.1.1.2 Equipment in close proximity to the human body but external to it . 41
A.1.1.3 Human torso simulator for ULP-AMI . 41
A.1.2 Test antenna . 42
A.1.3 Substitution antenna . 42
A.1.4 Optional additional indoor site . 43
A.2 Guidance on the use of radiation test sites . 44
A.2.1 Measuring distance . 44
A.2.2 Test antenna . 44
A.2.3 Substitution antenna . 44
A.2.4 Artificial antenna . 44
A.2.5 Auxiliary cables . 44
A.3 Further optional alternative indoor test site using an anechoic chamber . 45
A.3.1 Example of the construction of a shielded anechoic chamber . 45
A.3.2 Influence of parasitic reflections in anechoic chambers . 45
A.3.3 Calibration of the shielded RF anechoic chamber . 46
Annex B (normative): Technical performance of the spectrum analyser . 48
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/) . 49
Annex D (informative): Bibliography . 50
History . 51

ETSI

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6 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
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), and is now submitted for the Public Enquiry phase
of the ETSI standards Two-step Approval Procedure.
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".

Proposed national transposition dates
Date of latest announcement of this EN (doa): 3 months after ETSI publication
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 6 months after doa
Date of withdrawal of any conflicting National Standard (dow): 6 months after doa

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.
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7 Draft ETSI EN 301 839-1 V1.3.1 (2009-01)
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 be
...