SIST EN 302 195-2 V1.1.1:2004
(Main)Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
- Abstract
Develop specific standard for Ultra Low Power Active Medical Implants operating in the frequency range of 9kHz to 315kHz.
- Status
- Published
- Publication Date
- 30-Sep-2004
- Technical Committee
- RES - Radio equipment and systems
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 01-Oct-2004
- Due Date
- 01-Oct-2004
- Completion Date
- 01-Oct-2004
- Mandate
- M/284
SIST EN 302 195-2 V1.1.1:2004 is the Slovenian adoption of ETSI EN 302 195-2 for radio equipment used in Ultra Low Power Active Medical Implants (ULP-AMI) and accessories. It specifies the radio spectrum requirements for transmitters and receivers in the 9 kHz to 315 kHz range, so engineers and compliance teams can check whether equipment is designed to use spectrum without causing harmful interference.
What does SIST EN 302 195-2 V1.1.1:2004 specify?
SIST EN 302 195-2 V1.1.1:2004 specifies the harmonized radio spectrum requirements for ULP-AMI radio equipment under article 3.2 of the R&TTE Directive. It covers transmitters, receivers, and their accessories, and it is organized into scope, references, definitions, technical requirements, compliance testing, and interpretation of measurement results.
| Annex | What it covers |
|---|---|
| Annex A | Bibliography |
| Annex B | EN title in the official languages |
The scope includes ULP-AMI devices with RF output connection and dedicated antenna or integral antenna, and it covers telecommand, telemetry, digital modulation, and speech-capable equipment. It also covers fixed, mobile, and portable stations, which matters because different installation and use cases can change how equipment is tested and documented.
What are the key requirements of SIST EN 302 195-2 V1.1.1:2004?
SIST EN 302 195-2 V1.1.1:2004 focuses on radiated limits, receiver resilience, and test interpretation. The practical effect is that manufacturers and test labs must show that equipment stays within its declared operating profile and meets the relevant limits in the companion Part 1.
Transmitter limits
Clause 4.2 requires transmitters to stay within limits for radiated H-field, radiated E-field, modulation bandwidth, spurious emissions, and duty cycle. For a manufacturer, this means the transmitter design, antenna arrangement, and modulation settings must be controlled so the product does not exceed the applicable spectrum emissions limits.
The document also identifies power classes based on CEPT/ERC Recommendation 70-03. In practice, that gives a way to classify equipment power and compare it with the applicable radiated field or power limits.
Receiver limits
Clause 4.3 sets receiver requirements for blocking or desensitization and for spurious radiations below 30 MHz. This matters because a receiver must keep working in the presence of unwanted signals and must not emit excessive unintended radiation itself.
Test conditions and samples
Clause 5 requires testing under the manufacturer-declared environmental profile and with the test power source meeting the specified conditions. It also ties sample selection and the transmitter and receiver test suites to EN 302 195-1, so the test plan is not ad hoc and can be repeated by another lab.
Compliance reporting
Clause 6 requires the measured value to be compared with the corresponding limit and requires measurement uncertainty to be stated separately in the test report. It also gives uncertainty bounds for frequency, power, conducted and radiated emissions, temperature, and humidity, which helps buyers and assessors judge whether a test result is reliable enough for conformity assessment.
What terms does SIST EN 302 195-2 V1.1.1:2004 define?
- ULP-AMI - Ultra Low Power Active Medical Implants, the medical implant radio systems covered by the standard.
- RF - Radio Frequency, used in the scope for equipment with an RF output connection.
- H-field - The magnetic component of the radiated field, used here for transmitter emission limits.
- E-field - The electric component of the radiated field, also used for transmitter emission limits.
- Spurious emissions - Unwanted emissions outside the intended transmission, which are limited for transmitters.
- Blocking or desensitization - A receiver’s ability to keep operating when strong unwanted signals are present.
- Duty cycle - The fraction of time a transmitter is active, limited here for transmitter operation.
Who uses SIST EN 302 195-2 V1.1.1:2004?
SIST EN 302 195-2 V1.1.1:2004 is used by manufacturers of ULP-AMI devices and accessories, test laboratories, conformity assessment teams, and regulatory specialists working on radio equipment for medical implants. It is also relevant to designers of physician programmers/controllers, patient programmers, and implanted devices because these product types are named in the scope and are tested under the same spectrum framework.
Which standards are used with SIST EN 302 195-2 V1.1.1:2004?
- Directive 1999/5/EC (R&TTE Directive) - the legal framework for the harmonized article 3.2 requirement addressed by this standard.
- ETSI EN 302 195-1 (V1.1.1) - the companion Part 1 that provides the technical characteristics, definitions, limits, symbols, and test methods used throughout Part 2.
- CEPT/ERC Recommendation 70-03 - provides the short-range device power class basis referenced in the scope.
- ETSI ETR 028 - provides the method for calculating measurement uncertainty.
- Directive 98/34/EC - the mandate and notification framework mentioned in the foreword.
- Council Directive 89/336/EEC - the EMC directive referenced in the modular structure explanation.
- Council Directive 73/23/EEC - the LV directive referenced in the modular structure explanation.
What does the SIST EN 302 195-2 V1.1.1:2004 document contain?
The document contains the harmonized spectrum requirements, the compliance test suites, and the rules for interpreting measurement results. It also includes a modular-structure introduction showing how article 3.2 radio spectrum standards fit alongside EMC and safety standards under the R&TTE framework. The main body points to Part 1 for detailed test methods, while this part states which transmitter and receiver checks apply and how results are judged. Annex A lists background references, and Annex B gives the title in the official languages.
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Frequently Asked Questions
SIST EN 302 195-2 V1.1.1:2004 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive". This standard covers: Develop specific standard for Ultra Low Power Active Medical Implants operating in the frequency range of 9kHz to 315kHz.
Develop specific standard for Ultra Low Power Active Medical Implants operating in the frequency range of 9kHz to 315kHz.
SIST EN 302 195-2 V1.1.1:2004 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics; 33.100.01 - Electromagnetic compatibility in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 302 195-2 V1.1.1:2004 is associated with the following European legislation: EU Directives/Regulations: 1999/5/EC, TRRTP124; 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 302 195-2 V1.1.1:2004 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-oktober-2004
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Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in
the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP
-AMI) and accessories; Part 2: Harmonized EN covering essential requirements of article
3.2 of the R&TTE Directive
Ta slovenski standard je istoveten z: EN 302 195-2 Version 1.1.1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
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 302 195-2 V1.1.1 (2004-03)
Candidate Harmonized European Standard (Telecommunications series)
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
Radio equipment in the frequency range 9 kHz to 315 kHz
for Ultra Low Power Active Medical Implants (ULP-AMI)
and accessories;
Part 2: Harmonized EN covering essential requirements
of article 3.2 of the R&TTE Directive
2 ETSI EN 302 195-2 V1.1.1 (2004-03)
Reference
DEN/ERM-TG30-001-2
Keywords
health, inductive, magnetic, mobile, radio,
regulation, short range, SRD, testing
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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 2004.
All rights reserved.
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DECT , PLUGTESTS and UMTS are Trade Marks of ETSI registered for the benefit of its Members.
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ETSI
3 ETSI EN 302 195-2 V1.1.1 (2004-03)
Contents
Intellectual Property Rights.4
Foreword.4
Introduction .5
1 Scope.7
2 References.8
3 Definitions, symbols and abbreviations .8
3.1 Definitions.8
3.2 Symbols.8
3.3 Abbreviations.8
4 Technical requirements specifications.9
4.1 Environmental profile.9
4.2 Transmitter requirements.9
4.2.1 Radiated field strength or power.9
4.2.1.1 Radiated H-field.9
4.2.1.2 Radiated E-field.9
4.2.2 Permitted range of modulation bandwidth.9
4.2.3 Spurious emissions.9
4.2.4 Duty cycle.9
4.3 Receiver requirements.9
4.3.1 Blocking or desensitization.9
4.3.2 Receiver spurious radiations.10
5 Testing for compliance with technical requirements.10
5.1 Essential radio test suites.10
5.1.1 Environmental conditions for testing.10
5.1.1.1 Normal and extreme test-conditions.10
5.1.1.2 Test power source .10
5.1.2 Choice of samples for test suites.10
5.1.3 Transmitter test suites.10
5.1.3.1 Effective radiated H-field, carrier current or radiated power .10
5.1.3.2 Permitted frequency range of the modulation bandwidth .10
5.1.3.3 Spurious emissions.10
5.1.4 Receiver test suites.11
5.1.4.1 Blocking or desensitization .11
5.1.4.2 Spurious radiation.11
6 Interpretation of measurement results .11
Annex A (informative): Bibliography.12
Annex B (informative): The EN title in the official languages .13
History .14
ETSI
4 ETSI EN 302 195-2 V1.1.1 (2004-03)
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 Candidate Harmonized European Standard (Telecommunications series) has been produced by ETSI Technical
Committee Electromagnetic compatibility and Radio spectrum Matters (ERM).
The present document is part 2 of a multi-part deliverable covering Radio equipment in the frequency range 9 kHz to
315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories, 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".
The present document has been produced by ETSI in response to a mandate from the European Commission issued
under Council Directive 98/34/EC [5] (as amended) 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").
National transposition dates
Date of adoption of this EN: 12 March 2004
Date of latest announcement of this EN (doa): 30 June 2004
Date of latest publication of new National Standard
or endorsement of this EN (dop/e): 31 December 2004
Date of withdrawal of any conflicting National Standard (dow): 31 December 2005
ETSI
5 ETSI EN 302 195-2 V1.1.1 (2004-03)
Introduction
The present document is part of a set of standards designed to fit in a modular structure to cover all radio and
telecommunications terminal equipment under the R&TTE Directive [1]. Each standard is a module in the structure.
The modular structure is shown in figure 1.
Disability*
3.3f
Emergency*
3.3e
Fraud*
3.3d
3.3c
Privacy*
No harm to the network*
3.3b
* If needed
Scoped by
Interworking via the network*
equipment
3.3a class or type
Interworking with the network
Use of spectrum
3.2
New radio harmonized standards
Spectrum
Scoped by frequency and/or equipment type
Radio Product EMC
EN 301 489 multi-part EMC standard
3.1b
EMC
Generic and product standards also notified under EMC Directive
- If needed, new standards for human exposure to
Electromagnetic Fields,
- if needed, new standards for acoustic safety
3.1a
Standards also notified under LV Directive
Safety
Non-radio Radio (RE)
TTE Non-TTE
Figure 1: Modular structure for the various standards used under the R&TTE Directive [1]
ETSI
6 ETSI EN 302 195-2 V1.1.1 (2004-03)
The left hand edge of the figure 1 shows the different clauses of article 3 of the R&TTE Directive [1].
For article 3.3 various horizontal boxes are shown. Dotted lines indicate that at the time of publication of the present
document essential requirements in these areas have to be adopted by the Commission. If such essential requirements
are adopted, and as far and as long as they are applicable, they will justify individual standards w
...