ISO/IEC TR 20017:2011 PDF

Information technology — Radio frequency identification for item management — Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators

First page of standard ISO/IEC TR 20017:2011

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Title (English):

ISO/IEC TR 20017:2011

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 56
Publication date:: December 7, 2011
Edition:: ISO/IEC TR 20017 edition 1 version 1
ICS:: 35.040

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Description (English):

ISO/IEC TR 20017:2011 presents a test method and results for the evaluation of ISO/IEC 18000 radio frequency identification (RFID) interrogator electromagnetic interference (EMI) on implantable pacemakers and implantable cardioverter defibrillators (ICDs). ISO/IEC TR 20017:2011 looks at the various public reports on the electromagnetic compatibility between RFID interrogators, implantable pacemakers, and ICDs. It recommends the development of a uniform testing protocol and a repository of test results from experiments using those test protocols.

Technical details

Technical committee: ISO/IEC JTC 1/SC 31 - Automatic identification and data capture techniques
SKU: ISO/IEC TR 20017:2011

Abstract

Overview

ISO/IEC TR 20017:2011 is an informative Technical Report addressing the electromagnetic interference (EMI) impact of ISO/IEC 18000 RFID interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators (ICDs). The report presents a test method and experimental results, reviews public studies on RFID–implantable medical device electromagnetic compatibility (EMC), and recommends development of a uniform test protocol and a centralized repository of test results.

Key Topics and Requirements

Scope and objective: Evaluate EMI from ISO/IEC 18000 RFID interrogators (LF, HF, UHF) on cardiac implantable devices and identify gaps in existing study methods.
Test method & results: Presents an evaluation approach and summarizes experimental outcomes from multiple studies (including FDA/AAMI and JAISA/Hokkaido-University reports). The TR notes variability across studies and attributes differences to device models, interrogator parameters (carrier frequency, modulation, continuous/intermittent modes), and test protocols.
EMI findings (summary of reviewed studies):
- LF RFID readers (low-frequency) showed the highest incidence of clinically significant interference in several tests.
- HF readers produced fewer incidents; UHF readers and continuous-wave exposures showed minimal or no observed reactions in the referenced studies.
Need for harmonization: Strong recommendation to develop a uniform EMC test protocol for RFID vs. implantable devices and to maintain a repository of test results to improve reproducibility and risk assessment.
Normative references and terms: Aligns with related standards (ISO 14708 series, ANSI/AAMI/IEC 60601-1-2, ANSI/AAMI PC69, AAMI TIR18) and defines common terminology for RFID and implantable devices.

Practical Applications and Who Uses This Standard

Medical device manufacturers - to assess and mitigate EMI risks for pacemakers and ICDs during product development.
RFID system designers and vendors - to design interrogators and deployment plans that minimize interference in healthcare settings.
Hospital biomedical engineers and facility planners - to evaluate safe placement and operation of RFID readers near patients with implantable devices.
EMC test laboratories and certification bodies - to develop repeatable test methods and populate shared test-result repositories.
Regulators and standards developers - to inform policy, guidance, and future normative standards on RFID/medical-device coexistence.

Related Standards

ISO/IEC 18000 (RFID air interface standards)
ISO 14708-1 / ISO 14708-2 (active implantable medical devices)
ANSI/AAMI/IEC 60601-1-2 (medical equipment EMC)
ANSI/AAMI PC69; AAMI TIR18 (AIMD EMC test protocols and guidance)

Keywords: ISO/IEC TR 20017:2011, RFID EMI pacemaker, implantable cardioverter defibrillator, ISO/IEC 18000, EMC testing, RFID interrogator, implantable medical device compatibility.

Related standards

Standards mentioned in the description

Abstract

Overview

Key Topics and Requirements

Scope and objective: Evaluate EMI from ISO/IEC 18000 RFID interrogators (LF, HF, UHF) on cardiac implantable devices and identify gaps in existing study methods.
Test method & results: Presents an evaluation approach and summarizes experimental outcomes from multiple studies (including FDA/AAMI and JAISA/Hokkaido-University reports). The TR notes variability across studies and attributes differences to device models, interrogator parameters (carrier frequency, modulation, continuous/intermittent modes), and test protocols.
EMI findings (summary of reviewed studies):
- LF RFID readers (low-frequency) showed the highest incidence of clinically significant interference in several tests.
- HF readers produced fewer incidents; UHF readers and continuous-wave exposures showed minimal or no observed reactions in the referenced studies.
Need for harmonization: Strong recommendation to develop a uniform EMC test protocol for RFID vs. implantable devices and to maintain a repository of test results to improve reproducibility and risk assessment.
Normative references and terms: Aligns with related standards (ISO 14708 series, ANSI/AAMI/IEC 60601-1-2, ANSI/AAMI PC69, AAMI TIR18) and defines common terminology for RFID and implantable devices.

Practical Applications and Who Uses This Standard

Medical device manufacturers - to assess and mitigate EMI risks for pacemakers and ICDs during product development.
RFID system designers and vendors - to design interrogators and deployment plans that minimize interference in healthcare settings.
Hospital biomedical engineers and facility planners - to evaluate safe placement and operation of RFID readers near patients with implantable devices.
EMC test laboratories and certification bodies - to develop repeatable test methods and populate shared test-result repositories.
Regulators and standards developers - to inform policy, guidance, and future normative standards on RFID/medical-device coexistence.

Related Standards

ISO/IEC 18000 (RFID air interface standards)
ISO 14708-1 / ISO 14708-2 (active implantable medical devices)
ANSI/AAMI/IEC 60601-1-2 (medical equipment EMC)
ANSI/AAMI PC69; AAMI TIR18 (AIMD EMC test protocols and guidance)

Keywords: ISO/IEC TR 20017:2011, RFID EMI pacemaker, implantable cardioverter defibrillator, ISO/IEC 18000, EMC testing, RFID interrogator, implantable medical device compatibility.

ISO/IEC TR 20017:2011 PDF

Technical details

Abstract

Overview

Key Topics and Requirements

Practical Applications and Who Uses This Standard

Related Standards

Related standards

Abstract

Overview

Key Topics and Requirements

Practical Applications and Who Uses This Standard

Related Standards

Related standards

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