ISO/IEC TR 20017:2011

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.