SIST EN 301 839-2 V1.1.1:2003

• Abstract:

  To add this piece of standard to the EN 300 220-1 Rev1 and to support CEPT/ERC Rec 1 and to support CEPT/ERC Rec 70-03 Annex 12. Technical characteristics and test methods for Ultra Low Power Active medical implants.

• Status: Published
• Publication Date: 28-Feb-2003
• ICS: 33.060.20 - Receiving and transmitting equipment
• ICS: 33.100.01 - Electromagnetic compatibility in general
• Technical Committee: RES - Radio equipment and systems
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Mar-2003
• Due Date: 01-Mar-2003
• Completion Date: 01-Mar-2003
• Directive: 1999/5/EC - 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
• Mandate: M/284
• Ref Project: ETSI EN 301 839-2 V1.1.1 (2001-07) - Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive

• Official Journal Project Relation: 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
• Effective Date: 25-Jan-2010

Overview

SIST EN 301 839-2 V1.1.1:2003 is a harmonized European standard developed by the Slovenski inštitut za standardizacijo (SIST) in alignment with ETSI and the R&TTE Directive. This standard specifies the essential requirements for electromagnetic compatibility (EMC) and radio spectrum use for radio equipment operating in the 402 MHz to 405 MHz frequency band, specifically for Ultra Low Power Active Medical Implants (ULP-AMI) and their accessories. It covers key compliance elements stated in article 3.2 of the R&TTE Directive (1999/5/EC).

The standard aims to promote efficient and interference-free use of the radio spectrum for medical implant devices, supporting European policy objectives, such as CEPT/ERC Recommendation 70-03 Annex 12 and the requirements in EN 300 220-1. It is specifically aimed at ensuring the safety, reliability, and regulatory compliance of active medical implants, including their radio-based communication systems.

Key Topics

• Frequency Band: Specifies requirements for equipment operating strictly within the 402 MHz to 405 MHz band, a spectrum reserved for implanted medical devices and their associated programmers or accessories.
• Essential Requirements: Aligns with R&TTE Directive article 3.2, ensuring equipment uses spectrum efficiently to prevent harmful interference.
• Technical Characteristics: Addresses design aspects such as frequency error, emission bandwidth, effective radiated power, spurious emissions, and frequency stability under various power and environmental conditions.
• Conformance Testing:
  • Detailed test methods to assess compliance with emission, power, and stability requirements.
  • Measurement uncertainty and environmental test conditions specified to ensure reliable and repeatable results.
• Mechanical & Electrical Safety:
  • Requirements for device construction, antennas, controls, and transmitter shut-off facilities.
  • Provisions for various power sources, battery types, and operational temperature ranges relevant to implanted devices.
• Monitoring System: Defines compliance for monitoring spectrum access within medical implant communications systems (MICS).

Applications

The practical application of SIST EN 301 839-2 V1.1.1:2003 is focused on manufacturers, designers, and assessors of ultra low power active medical implants, as well as their supporting accessories. Key application points include:

• Medical Device Manufacturing: Ensures that active implants and their communication accessories meet European radio and EMC requirements, facilitating CE marking and market access in the EU.
• Testing and Certification: Provides a structured framework for third-party testing organizations to assess the conformance of medical implant communication systems.
• Regulatory Compliance: Supports national and EU-level regulatory processes, helping health authorities and market surveillance bodies verify device safety and legality.
• Healthcare Providers: Ensures the safe function and minimized risk of interference for critical medical equipment, directly benefiting patient safety and device reliability.

By adhering to this standard, manufacturers can demonstrate that their devices effectively use the assigned spectrum, minimize interference risk, and are constructed in accordance with robust mechanical and electrical safety principles.

Related Standards

Several standards are directly related or referenced within SIST EN 301 839-2 V1.1.1:2003 to provide a comprehensive regulatory framework:

• EN 301 839-1: Specifies the technical characteristics, EMC requirements, and test methods for radio equipment in this frequency band.
• EN 300 220-1: General requirements for short-range devices, referenced for alignment.
• EN 301 489: The multi-part EMC standard for radio equipment.
• CEPT/ERC Recommendation 70-03, Annex 12: European recommendations governing spectrum use for medical devices.
• Council Directives 1999/5/EC (R&TTE), 89/336/EEC (EMC), and 90/385/EEC (Active Implantable Medical Devices): Legal underpinnings for essential health, safety, and EMC requirements.

Adhering to SIST EN 301 839-2 V1.1.1:2003 ensures regulatory alignment, spectrum efficiency, and patient safety for ultra low power active medical implants across Europe.

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 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in general33.060.20Sprejemna in oddajna opremaReceiving and transmitting equipmentICS:Ta slovenski standard je istoveten z:EN 301 839-2 Version 1.1.1SIST EN 301 839-2 V1.1.1:2003en01-marec-2003SIST EN 301 839-2 V1.1.1:2003SLOVENSKI
STANDARD
ETSI EN 301 839-2 V1.1.1 (2002-06)Candidate Harmonized European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Radio equipment in the frequency range 402 MHz to 405 MHzfor Ultra Low Power Active Medical Implants and Accessories;Part 2: Harmonized EN covering essential requirementsof article 3.2 of the R&TTE Directive
ETSI ETSI EN 301 839-2 V1.1.1 (2002-06) 2
Reference REN/ERM-RP08-0404-2 Keywords radio, regulation, SRD, testing ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
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Important notice Individual copies of the present document can be downloaded from: http://www.etsi.org The present document may be made available in more than one electronic version or in print. In any case of existing or perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF). In case of dispute, the reference shall be the printing on ETSI printers of the PDF version kept on a specific network drive within ETSI Secretariat. Users of the present document should be aware that the document may be subject to revision or change of status. Information on the current status of this and other ETSI documents is available at http://portal.etsi.org/tb/status/status.asp If you find errors in the present document, send your comment to: [e-mail] Copyright Notification No part may be reproduced except as authorized by written permission. The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2002. All rights reserved.
DECTTM, PLUGTESTSTM and UMTSTM are Trade Marks of ETSI registered for the benefit of its Members. TIPHONTM and the TIPHON logo are Trade Marks currently being registered by ETSI for the benefit of its Members. 3GPPTM is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. SIST EN 301 839-2 V1.1.1:2003

ETSI ETSI EN 301 839-2 V1.1.1 (2002-06) 3
Contents Intellectual Property Rights.5 Foreword.5 Introduction.6 1 Scope.8 2 References.8 3 Definitions and abbreviations.9 3.1 Definitions.9 3.2 Abbreviations.9 4 Technical requirements specifications.10 4.1 Environmental profile.10 4.1.1 General.10 4.1.2 Temperature.10 4.1.3 Power supply voltages.10 4.1.3.1 Mains voltage range.10 4.1.3.2 Regulated lead-acid battery power sources.10 4.1.3.3 Power sources using other types of batteries.11 4.1.3.4 Other power sources.11 4.2 Conformance requirements.11 4.2.1 Mechanical and electrical design.11 4.2.1.1 General.11 4.2.1.2 Antennas.11 4.2.1.3 Controls.11 4.2.1.4 Transmitter shut-off facility.11 4.2.2 Frequency error.12 4.2.2.1 Definition.12 4.2.2.2 Limits.12 4.2.2.3 Conformance.12 4.2.3 Emission bandwidth.12 4.2.3.1 Definition.12 4.2.3.2 Limits.12 4.2.3.3 Conformance.12 4.2.4 Effective radiated power of the fundamental emission.12 4.2.4.1 Definition.12 4.2.4.2 Limits.12 4.2.4.3 Conformance.12 4.2.5 Spurious emissions.12 4.2.5.1 Definition.12 4.2.5.2 Limits.12 4.2.5.3 Conformance.12 4.2.6 Frequency stability under low voltage conditions.13 4.2.6.1 Definition.13 4.2.6.2 Limits.13 4.2.6.3 Conformance.13 4.2.7 Spurious radiation of receivers.13 4.2.7.1 Definition.13 4.2.7.2 Limits.13 4.2.7.3 Conformance.13 4.2.8 Monitoring system.13 4.2.8.1 Definition.13 4.2.8.2 Limits.13 4.2.8.3 Conformance.13 5 Testing for compliance with technical requirements.13 5.1 Environmental conditions for testing.13 SIST EN 301 839-2 V1.1.1:2003

ETSI ETSI EN 301 839-2 V1.1.1 (2002-06) 4
5.2 Interpretation of the measurement results.14 5.3 Essential radio test suites.14 5.3.1 Frequency error.14 5.3.2 Emission bandwidth.14 5.3.3 Effective radiated power of the fundamental emission.14 5.3.4 Spurious emissions.14 5.3.5 Frequency stability under low voltage conditions.15 5.3.6 Spurious radiation of receivers.15 5.3.7 Monitoring system.15 Annex A (normative): The EN Requirements Table (EN-RT).16 Annex B (normative): The EN title in the official languages.17 Annex C (informative): Bibliography.18 History.19
ETSI ETSI EN 301 839-2 V1.1.1 (2002-06) 5
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 has been produced by ETSI in response to a mandate from the European Commission issued under Council Directive 98/34/EC [7] (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 [1] 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]. The present document is part 2 of a multi-part deliverable covering Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories, as identified below: Part 1: "Technical characteristics, including electromagnetic compatibility requirements, and test methods"; Part 2: "Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive". Technical specifications relevant to Directive 1999/5/EC [1] are given in annex A.
National transposition dates Date of adoption of this EN: 7 June 2002 Date of latest announcement of this EN (doa): 30 September 2002 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 March 2003 Date of withdrawal of any conflicting National Standard (dow): 31 March 2004
ETSI ETSI EN 301 839-2 V1.1.1 (2002-06) 6
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.
- If needed, new standards for human exposure to Electromagnetic Fields, - if needed, new standards for acoustic safety Use of spectrum * If needed Scoped by
equipment
class or type Scoped by frequency and/or equipment type Disability* Privacy* Fraud* No harm to the network* Emergency* Interworking via
the network* Interworking with the network Non-radio Radio (RE) Non-TTE TTE 3.1b 3.2 3.3c 3.3b 3.3a 3.3d 3.3e 3.3f Radio Product EMC EN 301 489 multi-part EMC standard Generic and product standards also notified under EMC Directive Standards also notified under LV Directive 3.1a New radio harmonized standards Spectrum EMC Safety
Figure 1: Modular structure for the various standards used under the R&TTE Directive SIST EN 301 839-2 V1.1.1:2003

ETSI ETSI EN 301 839-2 V1.1.1 (2002-06) 7
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 whose scope is likely to be specified by function or interface type. The vertical boxes show the standards under article 3.2 for the use of the radio spectrum by radio equipment. The scopes of these standards are specified either by frequency (normally in the case where frequency bands are harmonized) or by radio equipment type. For article 3.1b the diagram shows EN 301 489, the multi-part product EMC standard for radio used under the EMC Directive [2].
For article 3.1a the diagram shows the existing safety standards currently used under the LV Directive [3] and new standards covering human exposure to electromagnetic fields. New standards covering acoustic safety may also be required. The bottom of the figure shows the relationship of the standards to radio equipment and telecommunications terminal equipment. A particular equipment may be radio equipment, telecommunications terminal equipment or both. A radio spectrum standard will apply if it is radio equipment. An article 3.3 standard will apply as well only if the relevant essential requirement under the R&TTE Directive [1] is adopted by the Commission and if the equipment in question is covered by the scope of the corresponding standard. Thus, depending on the nature of the equipment, the essential requirements under the R&TTE Directive [1] may be covered in a set of standards. The modularity principle has been taken because: •
it minimizes the number of standards needed. Because equipment may, in fact, have multiple interfaces and functions it is not practicable to produce a single standard for each possible combination of functions that may occur in an equipment; •
it provides scope for standards to be added: - under article 3.2 when new frequency bands are agreed; or - under article 3.3 should the Commission take the necessary decisions;
without requiring alteration of standards that are already published; •
it clarifies, simplifies and promotes the usage of Harmonized Standards as the relevant means of conformity assessment. SIST EN 301 839-2 V1.1.1:2003

ETSI ETSI EN 301 839-2 V1.1.1 (2002-06) 8
1 Scope The present document applies to Ultra Low Power-Active Medical Implants (ULP-AMI) and accessories as described in Directive 90/385/EEC [4], operating in a Medical Implant Communications System (MICS) in the frequency band 402 MHz to 405 MHz.
NOTE 1: The present document applies to operation in the band 402 MHz to 405 MHz only; devices that can also operate in spectrum outside this band should also meet any applicable requirements for operation in such bands. 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". 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] will apply to equipment within the scope of the present document. NOTE 2: 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. [1] Directive 1999/5/EC of the European
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