SIST EN 301 489-27 V1.1.1:2005

• Abstract:

  Maintenance to EN 301 489-3. Alignment of the classification for SDRs used in part 3 with that used in EN 300 220. Development of edition 2 of EN 301 489-3 for aplication as harmonised standard under the R&TTE Directive. This revision is to include additional immunity requirements for active medical devices.

• Status: Published
• Publication Date: 31-Jan-2005
• ICS: 11.040.99 - Other medical equipment
• ICS: 33.060.99 - Other equipment for radiocommunications
• 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-Feb-2005
• Due Date: 01-Feb-2005
• Completion Date: 01-Feb-2005
• 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
• Directive:

  ---

  TRRTP124 - Splošni akt o načrtu uporabe radijskih frekvenc (NURF-4)
• Mandate: M/284
• Ref Project: ETSI EN 301 489-27 V1.1.1 (2004-06) - Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P)

Overview

SIST EN 301 489-27 V1.1.1:2005 is a key international standard focusing on electromagnetic compatibility (EMC) and radio spectrum matters for ultra low power active medical implants (ULP-AMI) and related peripheral devices (ULP-AMI-P). Developed by SIST to align with ETSI EN 301 489-27, this standard outlines EMC requirements for ensuring reliable operation of implanted medical devices and their communication peripherals, addressing specific needs in highly sensitive medical environments.

This document also provides maintenance updates to EN 301 489-3, aligns the classification of software-defined radios (SDRs) used in Part 3 with EN 300 220, and supports the development of the second edition of EN 301 489-3 as a harmonized standard under the R&TTE Directive. An essential update includes additional immunity requirements to enhance the EMC of active medical devices.

Key Topics

• Electromagnetic Compatibility (EMC): Establishes requirements to ensure ultra low power active medical implants and their peripherals operate without interference from or to other electronic and radio equipment.
• Ultra Low Power Active Medical Implants (ULP-AMI): Addresses the unique challenges and regulatory expectations for medical implants utilizing very low power radio communication.
• Peripheral Devices (ULP-AMI-P): Sets out EMC requirements for devices that work in concert with ULP-AMI implants, ensuring overall system reliability.
• Maintenance and Alignment: Provides updates and alignment of SDR classification as outlined in other harmonized standards, promoting consistency across medical and communication devices.
• Immunity Requirements: Introduces enhanced immunity criteria for active medical devices, ensuring they function safely and without malfunction due to electromagnetic disturbances.

Applications

The practical value of SIST EN 301 489-27 V1.1.1:2005 is seen across a range of critical areas:

• Medical Device Manufacturers: Ensures that ultra low power active medical implants and their supporting devices meet internationally recognized EMC standards, facilitating compliance and market access across Europe and globally.
• Product Certification: Underpins device design, testing, and certification processes, making it integral for meeting the requirements of the R&TTE Directive and similar regulatory frameworks.
• Healthcare Safety: Contributes to patient safety by minimizing risks of electromagnetic interference, which is crucial for medical implants that support or monitor vital bodily functions.
• Research and Development: Provides a framework for innovators developing next-generation wireless medical devices, enabling compatibility and interoperability within healthcare settings.
• Hospital and Clinical Use: Supports reliable operation of implanted devices and their peripherals within hospitals, clinics, and home care environments, where multiple wireless and electromagnetic sources are present.

Related Standards

To support comprehensive compliance and design, the following related standards are relevant:

• EN 301 489-3: Core EMC standard for short-range devices, including medical applications.
• EN 300 220: Standard for radio equipment to be used in the 25 MHz to 1,000 MHz frequency range with power levels up to 500 mW.
• R&TTE Directive: European Directive related to radio and telecommunications equipment, now succeeded by the Radio Equipment Directive (RED).
• ISO 14708 Series: Standards for active implantable medical devices, focusing on safety and performance.
• IEC 60601-1-2: General EMC requirements for medical electrical equipment.

By implementing SIST EN 301 489-27 V1.1.1:2005, organizations enhance their product's reliability, safety, and regulatory compliance, supporting innovation and trust in medical technology involving ultra low power wireless medical devices.

SLOVENSKI STANDARD
01-februar-2005
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Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic
Compatibility (EMC) standard for radio equipment and services; Part 27: Specific
conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral
devices (ULP-AMI-P)
Ta slovenski standard je istoveten z: ETSI EN 301 489-27 V1.1.1 (2004-06)
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
33.060.99 Druga oprema za radijske Other equipment for
komunikacije radiocommunications
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.

SIST EN 301 489-27 V1.1.1:
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