EMC & Wireless Compliance for Active Implantable Medical Devices
Ensuring Safety and Performance in a Connected World
02 July 2019
Like any medical device, active implantable medical devices (AIMDs) are expected to maintain basic safety and essential performance without interfering with other equipment in their vicinity or the electromagnetic (EM) environment. Ensuring the safety and performance of these devices is critical, requiring the balance of several standards.
Electromagnetic interference (EMI) in AIMDs can lead to malfunction, damage, heating, or local increase of induced electrical current density within the patient. AIMDs are evaluated to the ISO14708 or EN45502 family of standards to ensure electromagnetic compatibility (EMC). The primary concern with these tests is to ensure the basic safety and essential performance of the AIMD in its use. Products are evaluated to determine the how EMI affects them, and they are tested to verify protection from static magnetic fields, AC magnetic fields and EM fields. The standards require a risk management approach; manufacturers must consider potential risks and ways to mitigate them as devices are developed
Because AIMDs can have wireless technologies such as Bluetooth, WiFi, wireless induction charging, and RFID chips, they must be evaluated for coexistence, security and functionality. The most common sources for wireless requirements are the IEC and CISPR. These regulations cover output power, effective radiated power, occupied bandwidth, power spectral density, spurious emissions, frequency stability and specific absorption rate (SAR). These considerations ensure the AIMD's safety and performance not only as it interacts with other devices, but also as it functions within the body. It is important to consider the governing bodies and their requirements when developing AIMDs.
Because AIMDs are complex devices that stay with a patient for an extended period of time, it is extremely important to ensure their safety and performance in regard to EMC and wireless coexistence. Knowing which standards and requirements apply to your product and considering them throughout the production process will help you complete the testing and other requirements and get a marketable product to the industry more quickly and effectively.
For more information about EMC and wireless testing for AIMDs, download our complimentary webinar recording.