| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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19-17
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| Standard | |
IEEE ANSI C63.18-2014
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 |
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Scope/Abstract| This recommended practice is a guide to evaluating the electromagnetic immunity of medical devices to radiated radio-frequency (RF) emissions from common RF transmitters (e.g., two-way radios; walkietalkies; mobile phones; wireless-enabled tablets, e-readers, laptop computers, and similar devices; radiofrequency identification (RFID) readers; networked mp3 players; two-way pagers; and wireless personal digital assistants [PDAs]). This protocol does not provide a comprehensive test or offer any guarantee, but it is a basic evaluation that can help identify medical devices that might be particularly vulnerable to interference from common RF transmitters. The ad hoc test protocol can be used to evaluate existing or newly purchased medical devices or can be implemented for the purpose of prepurchase evaluation. This recommended practice applies to medical devices used in health-care facilities, but it can also be adapted to medical devices in home health-care or mobile health-care settings. It does not apply to implantable medical devices (e.g., pacemakers and defibrillators), transport environments such as ambulances and helicopters, or RF transmitters rated at more than 8 W of output power. Testing with transmitters greater than 8 W in health-care facilities is not recommended because of possible adverse effects on critical-care medical devices that are in use in nearby areas of the facility. Finally, this recommended practice does not address in-band RF interference where the fundamental frequency of an RF transmitter overlaps with frequencies used by a hospital wireless network or monitoring or used by other medical device wireless links. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Radio Frequency Wireless Technology in Medical Devices, Issued August 13, 2013
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organizations
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
