AAMI TIR69-2017 (2020) PDF

Full title and description

AAMI TIR69:2017/(R)2020 — Risk management of radio‑frequency wireless coexistence for medical devices and systems. This Technical Information Report (TIR) provides a process for evaluating RF wireless coexistence as part of overall medical device risk management, including pre‑test activities, tier selection, test methods, reporting and post‑test analysis, plus sample reports and documentation guidance.

Abstract

This TIR describes a tiered evaluation process to assess how a medical device that incorporates RF wireless technologies will coexist in its intended RF environment. It guides manufacturers and test labs through information gathering, selection of test tier, execution of coexistence testing, interpretation of results, and integration of findings into the device risk management file. The report also provides example report templates and recommendations for documenting mitigation or design changes where coexistence risks are identified.

General information

• Status: Current (TIR in force; reaffirmed 2020).
• Publication date: Original designation 2017; TIR reaffirmed/published as AAMI TIR69:2017/(R)2020 — Date of publication listed as 10 April 2020.
• Publisher: Association for the Advancement of Medical Instrumentation (AAMI).
• ICS / categories: Medical equipment / medical electrical equipment and systems (ICS grouping for medical equipment, typically 11.040.xx).
• Edition / version: AAMI TIR69:2017 with reaffirmation notation (R)2020 — commonly cited as AAMI TIR69:2017/(R)2020.
• Number of pages: 61 pages (ISBN: 978-1-57020-656-6 as listed by the publisher).

Scope

The TIR applies to medical devices and systems that incorporate RF wireless technology used to perform or control a medical function or to communicate medical data. It is intended to help manufacturers and evaluators determine the appropriate level of wireless coexistence assessment for a device in its intended environment and to document coexistence risks and mitigations within the device risk management process. The guidance covers pre‑test information collection, tier selection, test execution, reporting and post‑test analysis.

Key topics and requirements

• Tiered evaluation approach for RF wireless coexistence (selection criteria for tiered testing based on device function and risk).
• Pre‑test information gathering: intended use environment, radio characteristics, expected interferers, performance criteria and worst‑case conditions.
• Test design and execution guidance for laboratory and site testing to evaluate coexistence performance.
• Reporting templates and recommended content to integrate test results into risk management documentation.
• Post‑test analysis: assessing residual risk, specifying mitigations, and updating design or labeling as needed.
• References and alignment with related EMC, wireless and medical device risk standards and guidance (e.g., IEC/ISO/TR guidance, ANSI C63.x, IEC 60601‑1‑2 and related documents).

Typical use and users

Primary users are medical device manufacturers (design and systems engineers), risk managers, regulatory affairs specialists, EMC test laboratories and clinical/biomedical engineers. The TIR is used during design and premarket evaluation to document wireless coexistence assessment, to support regulatory submissions, and to plan EMC/wireless testing or mitigation measures before deployment in clinical settings. OEMs who integrate commercial wireless modules or deploy devices in congested RF environments will find the guidance particularly relevant.

Related standards

Key related documents and standards often referenced alongside AAMI TIR69 include: ANSI/AAMI/IEC 60601‑1‑2 (electromagnetic disturbances requirements), IEC/TR 80001‑2‑3 (guidance for wireless networks), ANSI C63.27 (wireless coexistence test methods), ISO/TR 21730 and other AAMI TIRs on EMC and device connectivity. The TIR also cross‑references relevant IEEE and IEC coexistence and spectrum management publications.

Keywords

wireless coexistence, RF coexistence, medical devices, risk management, EMC, wireless testing, RF interference, coexistence testing, AAMI TIR69, IEC 60601‑1‑2.

FAQ

Q: What is this standard?

A: AAMI TIR69 is a Technical Information Report providing guidance and a process for evaluating radio‑frequency wireless coexistence of medical devices and systems and for integrating coexistence findings into device risk management.

Q: What does it cover?

A: It covers pre‑test information gathering, selection of a tiered testing approach, test execution and reporting, post‑test analysis and recommendations for documenting coexistence risks and mitigations in the device risk file. It is not a mandatory test method standard but provides structured guidance and example reports.

Q: Who typically uses it?

A: Device manufacturers, EMC/wireless test labs, regulatory affairs and quality/risk engineers, and clinical/biomedical engineering teams responsible for ensuring that RF‑enabled medical devices perform safely in realistic RF environments.

Q: Is it current or superseded?

A: The document is the 2017 TIR with a reaffirmation notation in 2020 (AAMI TIR69:2017/(R)2020) and is listed as current by standards resellers and the publisher. Users should confirm the publisher’s catalog for any later revisions or withdrawals before relying on the document for regulatory submissions.

Q: Is it part of a series?

A: Yes — it is part of AAMI’s suite of Technical Information Reports and guidance documents addressing medical device EMC, connectivity and risk management; it complements other AAMI TIRs and international guidance on wireless networks and medical device interoperability.

Q: What are the key keywords?

A: Wireless coexistence, RF interference, EMC, medical device connectivity, risk management, coexistence testing, AAMI TIR69.