SIST EN 301 839-2 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 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
- Abstract
EN 301 839 shall be revised: 1. Generic definitions shall be used and inconsistencies be removed in EN 301 839-1 and -2. 2. At present EN 301 839-1 describes LBT as interference mitigation technology. It is suggested that also an alternative interference mitigation technology is introduced in EN 301 839-1. Possible candidates for this interference mitigation technology are: a duty cycle limitation to less than 0.1% a duty cycle limitation to less than 0.1% on one channel (300 kHz bandwidth) a power reduction to less than 250 nW Devices respecting this interference mitigation technology can coexist with devices using LBT. Note: subject referred to RM for considerations as agreed at ERM#23 (see summary record)
The present document applies to the following radio equipment types:
• Ultra Low Power Active Medical Implants (ULP-AMI);
• and Peripherals (ULP-AMI-P).
These radio equipment types are capable of operating in all or any part of the frequency bands given below.
The present document is intended to cover the provisions of Directive 1999/5/EC [1] (R&TTE Directive). Article 3.2, which states that "….. radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communications and orbital resources so as to avoid harmful interference". An AIMD is regulated under the AIMD Directive 90/385/EEC [2]: 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 [1]. In addition to the present document, other ENs that specify technical requirements in respect of essential requirements
under other parts of Article 3 of the R&TTE Directive [1] may apply to equipment within the scope of the present document.
- Status
- Published
- Publication Date
- 08-Nov-2007
- Technical Committee
- MOC - Mobile Communications
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 25-Oct-2007
- Due Date
- 30-Dec-2007
- Completion Date
- 09-Nov-2007
- Mandate
- M/284
SIST EN 301 839-2 V1.2.1:2007 is the Slovenian adoption of ETSI EN 301 839-2 V1.2.1, a harmonized European standard for Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD). It covers Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in 402 MHz to 405 MHz, and it is written for manufacturers and test labs that need to assess Article 3.2 of the R&TTE Directive.
What does SIST EN 301 839-2 V1.2.1:2007 specify?
SIST EN 301 839-2 V1.2.1:2007 specifies the essential radio requirements for ULP-AMI and ULP-AMI-P equipment in the 402 MHz to 405 MHz band. It focuses on spectrum use, transmitter and receiver emissions, and the test evidence used for conformity assessment.
The document is organized into:
- Clause 1 - Scope
- Clause 2 - References
- Clause 3 - Definitions and abbreviations
- Clause 4 - Technical requirements and specifications
- Clause 5 - Testing for compliance with technical requirements
- Annex A - normative HS Requirements and conformance Test specifications Table (HS-RTT)
- Annex B - informative titles in official languages
- Annex C - informative bibliography
Clause 1 ties the standard to ULP-AMI and ULP-AMI-P equipment that can operate in all or part of the 402 MHz to 405 MHz bands for transmit and receive. Annex A is the key mapping table because it links each essential requirement to its test specification and shows whether the requirement is unconditional or conditional.
What are the key requirements of SIST EN 301 839-2 V1.2.1:2007?
SIST EN 301 839-2 V1.2.1:2007 requires both product design controls and radio performance checks. In practice, the standard tells the manufacturer what the equipment must declare, what must be measured, and which test results support conformity.
Equipment design and declared operating conditions
Clause 4.1 requires the manufacturer to declare the environmental profile and to keep compliance within its boundary limits. That means the equipment has to be assessed in the operating conditions it is intended for, not only in ideal laboratory conditions.
Clause 4.2.1 requires sound engineering practice, low interference potential, and control of antenna and user-accessible settings. The antenna must be integral, external dedicated, or both, and if an external connection is provided the manufacturer has to prevent use of unauthorized antennas.
Clause 4.2.1.4 allows an automatic transmitter shut-off or battery-saving feature to be made inoperative for testing if it would otherwise interfere. That matters because a lab must be able to run the required measurements on a stable transmitter.
Radio performance and spectrum access
Clauses 4.2.2 to 4.2.7 cover frequency error, emission bandwidth, effective radiated power of the fundamental emission, spurious emissions of the transmitter, frequency stability under low voltage conditions, and spurious radiation of receivers. The definitions and limits for these items are taken from EN 301 839-1, so Part 2 mainly points to the values and test methods that must be used.
Clause 4.2.8 requires the manufacturer to declare a spectrum access method. The options are LBT/AFA or LP/LDC, and if both are used the total emission bandwidth must not exceed 300 kHz. LP/LDC applies only to ULP-AMI operating in 403.5 MHz to 403.8 MHz, so the chosen access method directly affects product design and test planning.
Testing and measurement evidence
Clause 5 requires tests under representative environmental conditions and under the manufacturer-declared normal and extreme conditions. Clause 5.2 requires the test report to include measurement uncertainty, using TR 100 028, and Table 2 sets maximum uncertainty values for the listed radio, conducted, radiated, temperature, and humidity measurements.
Clause 5.3 gives the essential radio test suites for frequency error, emission bandwidth, power, spurious emissions, low-voltage stability, receiver spurious radiation, and spectrum access. For a compliance file, these are the tests that matter most.
What terms does SIST EN 301 839-2 V1.2.1:2007 define?
- ULP-AMI - Ultra Low Power Active Medical Implants, the implant radio equipment covered by the standard.
- ULP-AMI-P - Peripherals for ULP-AMI systems, covered alongside the implants.
- Environmental profile - The declared operating environment within which the equipment must still meet the technical requirements.
- Spectrum access method - The declared method for sharing the band, either LBT/AFA or LP/LDC.
- Essential Radio Test Suite - The set of tests marked as essential in Annex A for demonstrating conformity.
- Measurement uncertainty - The uncertainty value that has to be reported in test results and kept within the limits given in Table 2.
Who uses SIST EN 301 839-2 V1.2.1:2007?
Manufacturers of ULP-AMI radio parts and ULP-AMI-P peripherals use this standard to design the antenna, controls, emissions behavior, and spectrum access method. Test laboratories use it to plan measurements and write conformity reports. Quality managers, technical documentation teams, and compliance assessors use it to decide what evidence belongs in the technical file and which tests support presumption of conformity.
What changed in SIST EN 301 839-2 V1.2.1:2007 from the previous edition?
This edition follows ETSI EN 301 839-2 V1.1.1, published in June 2002.
Which standards are used with SIST EN 301 839-2 V1.2.1:2007?
Clause 2 references Directive 1999/5/EC, which gives the Article 3.2 legal basis for the harmonized standard, and Council Directive 90/385/EEC, which frames active implantable medical devices. It also uses ETSI EN 301 839-1 for definitions, limits, and test methods, and ETSI TR 100 028 for measurement uncertainty. Directive 98/34/EC is cited in the foreword in connection with the standards procedure.
What does the SIST EN 301 839-2 V1.2.1:2007 document contain?
The document contains the conformance requirements for mechanical and electrical design, frequency error, emission bandwidth, effective radiated power, transmitter spurious emissions, low-voltage stability, receiver spurious radiation, and spectrum access. It also contains the test clauses that verify those requirements and the rules for test conditions, power source, sample choice, and reporting uncertainty.
Annex A is the most useful annex for conformity work because it cross-references each essential requirement to its test specification and marks conditional items. The document also includes Table 1 for the service bands and Table 2 for maximum measurement uncertainty. Annex B gives the EN title in official languages, and Annex C lists bibliography items used with the standard.
Relations
- Effective Date
- 25-Jan-2010
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Frequently Asked Questions
SIST EN 301 839-2 V1.2.1:2007 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "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 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive". This standard covers: EN 301 839 shall be revised: 1. Generic definitions shall be used and inconsistencies be removed in EN 301 839-1 and -2. 2. At present EN 301 839-1 describes LBT as interference mitigation technology. It is suggested that also an alternative interference mitigation technology is introduced in EN 301 839-1. Possible candidates for this interference mitigation technology are: a duty cycle limitation to less than 0.1% a duty cycle limitation to less than 0.1% on one channel (300 kHz bandwidth) a power reduction to less than 250 nW Devices respecting this interference mitigation technology can coexist with devices using LBT. Note: subject referred to RM for considerations as agreed at ERM#23 (see summary record) The present document applies to the following radio equipment types: • Ultra Low Power Active Medical Implants (ULP-AMI); • and Peripherals (ULP-AMI-P). These radio equipment types are capable of operating in all or any part of the frequency bands given below. The present document is intended to cover the provisions of Directive 1999/5/EC [1] (R&TTE Directive). Article 3.2, which states that "….. radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communications and orbital resources so as to avoid harmful interference". An AIMD is regulated under the AIMD Directive 90/385/EEC [2]: 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 [1]. In addition to the present document, other ENs that specify technical requirements in respect of essential requirements under other parts of Article 3 of the R&TTE Directive [1] may apply to equipment within the scope of the present document.
EN 301 839 shall be revised: 1. Generic definitions shall be used and inconsistencies be removed in EN 301 839-1 and -2. 2. At present EN 301 839-1 describes LBT as interference mitigation technology. It is suggested that also an alternative interference mitigation technology is introduced in EN 301 839-1. Possible candidates for this interference mitigation technology are: a duty cycle limitation to less than 0.1% a duty cycle limitation to less than 0.1% on one channel (300 kHz bandwidth) a power reduction to less than 250 nW Devices respecting this interference mitigation technology can coexist with devices using LBT. Note: subject referred to RM for considerations as agreed at ERM#23 (see summary record) The present document applies to the following radio equipment types: • Ultra Low Power Active Medical Implants (ULP-AMI); • and Peripherals (ULP-AMI-P). These radio equipment types are capable of operating in all or any part of the frequency bands given below. The present document is intended to cover the provisions of Directive 1999/5/EC [1] (R&TTE Directive). Article 3.2, which states that "….. radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communications and orbital resources so as to avoid harmful interference". An AIMD is regulated under the AIMD Directive 90/385/EEC [2]: 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 [1]. In addition to the present document, other ENs that specify technical requirements in respect of essential requirements under other parts of Article 3 of the R&TTE Directive [1] may apply to equipment within the scope of the present document.
SIST EN 301 839-2 V1.2.1:2007 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics; 33.060.20 - Receiving and transmitting equipment; 33.100.01 - Electromagnetic compatibility in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 301 839-2 V1.2.1:2007 has the following relationships with other standards: It is inter standard links to SIST EN 301 839-2 V1.1.1:2003. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 301 839-2 V1.2.1:2007 is associated with the following European legislation: EU Directives/Regulations: 1999/5/EC; Standardization Mandates: M/284. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN 301 839-2 V1.2.1:2007 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2007
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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 2: Harmonized EN
covering essential requirements of article 3.2 of the R&TTE Directive
Ta slovenski standard je istoveten z: EN 301 839-2 Version 1.2.1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
33.060.20 Sprejemna in oddajna Receiving and transmitting
oprema equipment
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
ETSI EN 301 839-2 V1.2.1 (2007-07)
Harmonized 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 2: Harmonized EN covering essential requirements
of article 3.2 of the R&TTE Directive
2 ETSI EN 301 839-2 V1.2.1 (2007-07)
Reference
REN/ERM-TG30-002-2
Keywords
radio, regulation, SRD, testing
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ETSI
3 ETSI EN 301 839-2 V1.2.1 (2007-07)
Contents
Intellectual Property Rights.5
Foreword.5
1 Scope.6
2 References.6
3 Definitions and abbreviations.7
3.1 Definitions.7
3.2 Abbreviations.7
4 Technical requirements and specifications.7
4.1 Environmental profile.7
4.2 Conformance requirements.7
4.2.1 Mechanical and electrical design .7
4.2.1.1 General.7
4.2.1.2 Antennas.7
4.2.1.3 Controls.7
4.2.1.4 Transmitter shut-off facility.8
4.2.2 Frequency error.8
4.2.2.1 Definition.8
4.2.2.2 Limits.8
4.2.2.3 Conformance.8
4.2.3 Emission bandwidth.8
4.2.3.1 Definition.8
4.2.3.2 Limits.8
4.2.3.3 Conformance.8
4.2.4 Effective radiated power of the fundamental emission.8
4.2.4.1 Definition.8
4.2.4.2 Limits.8
4.2.4.3 Conformance.8
4.2.5 Spurious emissions of transmitter.8
4.2.5.1 Definition.8
4.2.5.2 Limits.8
4.2.5.3 Conformance.9
4.2.6 Frequency stability under low voltage conditions .9
4.2.6.1 Definition.9
4.2.6.2 Limits.9
4.2.6.3 Conformance.9
4.2.7 Spurious radiation of receivers .9
4.2.7.1 Definition.9
4.2.7.2 Limits.9
4.2.7.3 Conformance.9
4.2.8 Spectrum Access.9
4.2.8.1 LBT/AFA spectrum access.9
4.2.8.1.1 Definition.9
4.2.8.1.2 Limits.10
4.2.8.2 LP/LDC spectrum access .10
4.2.8.2.1 Definition.10
4.2.8.2.2 Limits.10
4.2.8.3 Conformance.10
5 Testing for compliance with technical requirements.10
5.1 Environmental conditions for testing .10
5.2 Interpretation of the measurement results .10
5.3 Essential radio test suites.11
5.3.1 Frequency error.11
5.3.2 Emission bandwidth.11
ETSI
4 ETSI EN 301 839-2 V1.2.1 (2007-07)
5.3.3 Effective radiated power of the fundamental emission.11
5.3.4 Spurious emissions of transmitter.11
5.3.5 Frequency stability under low voltage conditions .11
5.3.6 Spurious radiation of receivers .11
5.3.7 Spectrum Access.12
5.3.7.1 LBT/AFA spectrum access.12
5.3.7.2 LP/LDC spectrum access .12
5.3.8 Normal and extreme test-conditions .12
5.3.9 Test power source .12
5.3.10 Choice of samples for test suites.12
Annex A (normative): HS Requirements and conformance Test specifications Table
(HS-RTT).13
Annex B (informative): The EN title in the official languages .15
Annex C (informative): Bibliography.17
History .18
ETSI
5 ETSI EN 301 839-2 V1.2.1 (2007-07)
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 Harmonized European Standard (Telecommunications series) has been produced by ETSI Technical Committee
Electromagnetic compatibility and Radio spectrum Matters (ERM).
The present document has been produced by ETSI in response to a mandate from the European Commission issued
under Council Directive 98/34/EC (as amended) [5] laying down a procedure for the provision of information in the
field of technical standards and regulations.
The present document is intended to become a Harmonized Standard, the reference of which will be published in the
Official Journal of the European Communities referencing the 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 ("the R&TTE Directive") [1].
Technical specifications relevant to Directive 1999/5/EC are given in annex A.
The present document is part 2 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 2009
ETSI
6 ETSI EN 301 839-2 V1.2.1 (2007-07)
1 Scope
The present document applies to the following radio equipment types:
• Ultra Low Power Active Medical Implants (ULP-AMI);
• and Peripherals (ULP-AMI-P).
These radio equipment types are capable of operating in all or any part of the frequency bands given below.
Table 1: Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) service frequency bands
Ultra Low Power Active Medical Implants (ULP-AMI) and
Peripherals (ULP-AMI-P) service frequency bands
Transmit Ultra Low Power Active Medical Implants 402 MHz to 405 MHz
(ULP-AMI) and Peripherals (ULP-AMI-P)
Receive Ultra Low Power Active Medical Implants 402 MHz to 405 MHz
(ULP-AMI) and Peripherals (ULP-AMI-P)
The present document is intended to cover the provisions of Directive 1999/5/EC [1] (R&TTE Directive).
Article 3.2, which states that "…. radio equipment shall be so constructed that it effectively uses the spectrum allocated
to terrestrial/space radio communications and orbital resources so as to avoid harmful interference".
An AIMD is regulated under the AIMD Directive 90/385/EEC [2]: 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 [1].
In addition to the present document, other ENs that specify technical requirements in respect of essential requirements
under other parts of Article 3 of the R&TTE Directive [1] may apply to equipment within the scope of the present
document.
NOTE: A list of such ENs is included on the web site http://www.newapproach.org.
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] 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).
[2] 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.
ETSI
7 ETSI EN 301 839-2 V1.2.1 (2007-07)
[3] ETSI EN 301 839-1 (V1.2.1): "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".
[4] ETSI TR 100 028 (V1.4.1): "ElectroMagnetic Compatibility and Radio Spectrum Matters (ERM);
Uncertainties in the measurement of mobile radio equipment characteristics".
[5] Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a
procedure for the provision of information in the field of technical standards and regulations.
3 Definitions and abbreviations
3.1 Definitions
For the purposes of the present document, the terms and definitions given in EN 301 839-1 [3], clause 3.1 apply.
3.2 Abbreviations
For the purposes of the present document, the abbreviations given in EN 301 839-1 [3], clause 3.3 apply.
4 Technical requirements and specifications
4.1 Environmental profile
The technical requirements of the present document apply under the environmental profile for operation of the
equipment, which shall be declared by the manufacturer. The equipment shall comply with all the technical
requirements of the present document at all times when operating within the boundary limits of the declared operational
environmental profile.
4.2 Conformance requirements
4.2.1 Mechanical and electrical design
4.2.1.1 General
The equipment shall be designed, constructed and manufactured in accordance with sound engineering practice and
with the aim of minimizing harmful interference to other equipment and services and should not receive harmful
interference from other electronic devices. Transmitters and receivers may be individual or combination units.
4.2.1.2 Antennas
Equipment operating in the 402 MHz to 405 MHz band shall have an integral antenna, an external dedicated antenna or
both. If provision for an external antenna connection is made, the manufacturer or provider shall make provision to
prevent the use of an antenna other than that authorized by the manufacturer or provider.
4.2.1.3 Controls
Those controls that, if maladjusted, might increase the interference potentialities of the equipment shall not be easily
accessible to the user.
ETSI
8 ETSI EN 301 839-2 V1.2.1 (2007-07)
4.2.1.4 Transmitter shut-off facility
If the transmitter is equipped with an automatic transmitter shut-off facility or battery-saving feature and it interferes
with testing of the device, it shall be capable of being made inoperative for the purpose of testing.
4.2.2 Frequency error
4.2.2.1 Definition
The frequency error shall be
...