ANSI C63.18-2014 PDF

Full title and description

American National Standard — Recommended Practice for an On‑Site, Ad‑Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio‑Frequency (RF) Emissions from RF Transmitters. Provides a practical, on‑site protocol to assess how common RF transmitters (mobile phones, two‑way radios, RFID readers, tablets, laptops, wireless personal devices, etc.) may affect medical devices used in health‑care and similar settings.

Abstract

This recommended practice (C63.18‑2014) defines an ad‑hoc, on‑site test method intended for clinical and biomedical engineers and technical staff to: (1) rapidly evaluate electromagnetic (EM) immunity of non‑implantable medical devices to nearby RF transmitters, (2) identify observable device effects and approximate thresholds (transmit power and separation distances), and (3) generate objective information to support mitigation actions and institutional policies (for example, exclusion zones and device procurement considerations). The method emphasizes use of actual RF transmitters where practical and recommends, but does not require, use of an E‑field meter.

General information

• Status: Withdrawn (withdrawal date reported as October 31, 2024); previously reaffirmed in 2019 by the C63 committee.
• Publication date: ANSI approval May 16, 2014; published June 20, 2014 (edition year 2014).
• Publisher: Institute of Electrical and Electronics Engineers (IEEE) — published as an IEEE/ANSI standard.
• ICS / categories: Electromagnetic compatibility / Immunity (commonly listed under ICS 33.100.20).
• Edition / version: 2014 edition (supersedes C63.18‑1997).
• Number of pages: Publisher listings vary; common retailer records list ~64 pages (other listings show counts from ~59 to 126 depending on format/packaging). Users should check the specific PDF/print product listing for exact page counts.

Scope

Applies to non‑implantable medical devices used in health‑care facilities (and adaptable to home or mobile health‑care). It provides a basic, repeatable on‑site protocol for estimating radiated RF immunity to common portable and mobile transmitters with rated output powers up to ~8 W. It does not address implantable devices, transport environments (ambulances, helicopters), in‑band interference affecting hospital wireless networks, nor testing with high‑power transmitters above the stated power range. The guidance is intended for screening and mitigation planning rather than full laboratory certification.

Key topics and requirements

• Selection and prioritization of medical devices to be tested (criticality and clinical function).
• Preferred and alternative RF source options for ad‑hoc testing (use of real transmitters preferred; alternatives and annex guidance provided).
• Test set‑up and environment preparation (device operation modes, monitoring, and use of E‑field meters when available).
• Procedure for incremental exposure, observation of device effects, and determination of threshold distances/power levels.
• Reporting format and how to convert on‑site observations into mitigation actions (exclusion zones, signage, procurement criteria).
• Limitations and caveats: not a substitute for exhaustive laboratory immunity testing; results are approximate and context dependent.

Typical use and users

Intended for clinical engineers, biomedical engineering staff, hospital facilities managers, risk managers, and other technical personnel responsible for medical device safety and electromagnetic compatibility (EMC) in health‑care facilities. It is used for on‑site screening, pre‑purchase evaluations, troubleshooting apparent EMI events, and informing local policies on wireless device use.

Related standards

Related C63 series and EMC documents include earlier C63.18‑1997 (superseded), C63.19 (methods for compatibility between wireless devices and hearing aids), C63.4 (emission measurement methods), and other C63 guides on in‑situ immunity and site validation (e.g., C63.24, C63.25 series). Where applicable, IEC/ISO guidance for medical device EMC and risk management (e.g., IEC 60601‑1‑2 and related documents) should be consulted for laboratory and regulatory compliance.

Keywords

RF immunity; medical devices; electromagnetic compatibility (EMC); ad‑hoc on‑site testing; E‑field measurement; exclusion zone; separation distance; radiated RF emissions; clinical engineering; hospital EMC policy.

FAQ

Q: What is this standard?

A: It is a recommended practice (ANSI/IEEE C63.18‑2014) that describes an on‑site, ad‑hoc method to estimate how radiated RF emissions from common transmitters might affect non‑implantable medical devices.

Q: What does it cover?

A: It covers practical procedures for selecting devices to test, placing RF sources, observing device effects, measuring or estimating field strength (optionally using E‑field meters), and reporting thresholds and mitigation measures. It is a screening tool rather than a formal laboratory certification procedure.

Q: Who typically uses it?

A: Clinical and biomedical engineers, hospital technical staff, facility managers, and safety/risk personnel who need a rapid, repeatable way to identify devices vulnerable to common RF transmitters and to develop mitigation or policy responses.

Q: Is it current or superseded?

A: The 2014 edition was ANSI‑approved and published in 2014 but is reported withdrawn by some product listings with a withdrawal date of October 31, 2024. The C63 committee had reaffirmed the 2014 text in 2019 and signaled development of successor work; users should treat the 2014 text as archived/withdrawn and check whether a newer C63 publication or replacement has been issued before relying on it for current practice. Exact status and availability should be confirmed with IEEE/ANSI or the ANSC‑C63 secretariat for the latest disposition.

Q: Is it part of a series?

A: Yes — it is part of the ANSI/IEEE C63 family of EMC standards and guidance documents; it sits alongside other C63 standards addressing emissions, immunity, measurement instrumentation, site validation, and device‑specific guidance.

Q: What are the key keywords?

A: RF immunity, medical device EMC, ad‑hoc testing, E‑field meter, exclusion zone, clinical engineering, radiated emissions, separation distance.