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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Electromagnetic Compatibility - Documents Available to Help Resolve Medical Device EMC Problems

Two U.S. national medical device electromagnetic compatibility (EMC) documents were published to aid clinical/biomedical engineers in addressing the device EMC issue in an informed and consistent way: a technical information report published by AAMI, and a recommended practice for ad hoc EMC testing of devices published by IEEE. These documents were developed through consensus processes (similar to the ANSI standards process) with input from industry, government, users and independent parties. The documents are written in a straight-forward and easy to understand manner, making it easy for all those involved with the manufacturer and use of medical devices to understand the concerns about electromagnetic interference (EMI) and ways these concerns can be addressed.

The Association for the Advancement of Medical Instrumentation (AAMI) published Technical Information Report (TIR) 18, Guidance on electromagnetic compatibility of medical devices for clinical/biomedical engineers -Part 1: Radiated radio-frequency electromagnetic energy. TIR 18 provides information and guidance on medical device EMC to clinical engineers and other biomedical personnel to help them evaluate the radiated radio-frequency (RF) electromagnetic environment in their individual health-care facilities and implement actions needed to minimize the potential risks associated with electromagnetic interference (EMI) problems. This document contains sections on assessing the RF environment in the clinic, developing policies, examples of device interactions, and a bibliography of references for device EMC.

TIR No. 18 -1997 is available from:

Association for the Advancement of Medical Instrumentation

3330 Washington Blvd, Suite 400

Arlington, VA 22201-4598

Phone: 1-703-525-4890 or 1-800-332-2264

FAX: 1-703-276-0793

http://www.aami.org

 

  The American National Standards Institute (ANSI) Accredited Committee C63 (EMC) published C63.18, Recommended practice for an on-site, ad hoc test method for estimating radiated electromagnetic immunity of medical devices to specific radio-frequency transmitters. C63.18 is intended to provide an inexpensive, relatively reproducible test method for estimating the radiated RF electromagnetic immunity of medical devices to available, portable RF transmitters that might be operated in the vicinity. This document provides a test method that can be performed by clinical and biomedical engineers to improve reproducibility and inter-comparison of test results. It also provides information to facilitate development of policies and procedures for managing the use of specific RF transmitters within specific areas of a health-care facility.

ANSI C63.18 (IEEE product number SH94556) is available from:

The Institute for Electrical and Electronics Engineering (IEEE)

In the US and Canada: 1-800-678-IEEE (4333)

Outside the US: 1-732-981-0600

FAX: 1-732-981-9667

http://shop.ieee.org/store/default.asp