American National Standard for Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids
This standard applies to both wireless communications devices (WDs) and hearing aids. It sets forth uniform methods of measurement and parametric requirements for the electromagnetic and operational compatibility of hearing aids and WDs, including cellular phones, personal communications service (PCS), and voice-over-Internet-protocol (VoIP) devices, operating in the range of 614 MHz to 6 GHz.
Institute of Electrical and Electronics Engineers (IEEE)
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
A guide to evaluating electromagnetic immunity of medical devices against radiated radio-frequency (RF) emissions from common RF transmitters is provided in this recommended practice (e.g., two-way radios; walkie-talkies; mobile phones; wireless-enabled tablets, e-readers, laptop computers, and similar devices; RFID readers; networked mp3 players; two-way pagers; and wireless personal digital assistants [PDAs]). A comprehensive test or a guarantee is not provided by this protocol but, instead, a basic evaluation is given that can help identify medical devices that might be particularly vulnerable to interference from common RF transmitters.
Institute of Electrical and Electronics Engineers (IEEE) – International Committee on Electromagnetic Safety (SCC39)
Diretiva 2014/30/UE do Parlamento Europeu e do Conselho de 26 de fevereiro de 2014 relativa à harmonização da legislação dos Estados-Membros respeitante à compatibilidade eletromagnética (reformulação)
A presente diretiva regulamenta a compatibilidade eletromagnética dos equipamentos e tem como objetivo assegurar o funcionamento do mercado interno, exigindo que os equipamentos cumpram um nível adequado de compatibilidade eletromagnética.
Jornal Oficial da União Europeia, L 96/79, de 29/3/2014 (2014/30/EU)
Radiofrequency Interference with Medical Devices
The past few years have seen increased reports that medical devices, such as pacemakers, apnea monitors, electrically powered wheelchairs, etc., have failed to operate correctly because of interference from various emitters of radiofrequency energy. This condition is called radiofrequency interference (RFI). The consequences of these failures range from inconvenience to serious injuries and death. Reasons for this problem are twofold: 1) increasing numbers of electronically controlled medical devices with inadequate electronic protection against RFI, and 2) a significant increase in the number of RF sources in the environment. Medical devices are widely used outside the hospital and may be attached to, or implanted in, patients. Portable wireless communications equipment, including cellular phones, handheld transceivers, and vehicle mounted transceivers, comprise one of the largest sources of RFI. Some medical devices are especially sensitive to the type of digital modulation that some of the wireless communications devices utilize. (…) COMAR recommends that the various parties involved in the manufacture and use of RFI prone medical devices take steps to avoid serious RFI problems that may lead to safety hazards. Medical device manufacturers should design and test their products to ensure conformance with current RFI standards and educate the users of their devices about the possible symptoms of potential RFI. If there exists the possibility of RFI problems to medical devices, steps should be taken to ensure that all sources of RF energy be kept at a sufficient distance.
Institute of Electrical and Electronics Engineers (IEEE) Committee on Man and Radiation (COMAR)
Electromagnetic Compatibility of Medical Devices with Mobile Communications
The compatibility of mobile communication equipment with medical devices is an area where much published information and guidance is conflicting. We have hence organised a large study, based on research conducted at 18 locations including hospitals and MDA evaluation centres. Data were gathered for 178 different models of medical device using a wide range of radio handsets. Overall, in 23% of tests medical devices suffered electromagnetic interference (EMI) from handsets. 43% of these interference incidents would have had a direct impact on patient care, and were rated as serious.
Medicines and Healthcare products Regulatory Agency (MHRA)