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Regulatory and Practical Challenges in Wireless Medical Devices

NOV
09
2020
09. NOV 2020

Lecture electronica Conferences > electronica Medical Electronics Conference > Session 1: SAFETY, SECURITY & REGULATORY

15:30-16:00 h | Virtual

The ISM bands at 2.4 and 5 GHz receive a lot of attention and use, but bands at 438 and 915 MHz and other frequencies are also used for longer range ambulatory medical devices. As the use of the common wireless radio bands has grown, congestion of these bands is causing failure of wireless communications, a problem that is intermittent and hard to trace. No frequency band or protocol is immune to disruption of communications due to interference. To address the problems of congestion, standards bodies and regulatory agencies have produced recommendations and regulations to test wireless devices for robust operation in the presence of other signals, and to improve wireless device operation by setting standards for device behaviors. These tests and regulations go beyond the previous versions and require new on-the-air behavior which is intended to improve inter-device cooperation to reduce data loss and improve reliability and throughput of devices. Part of the improvement will come as devices are tested for ability to continue operation in the presence of dissimilar on-the-air protocols, such as Bluetooth®, WLAN and ZigBee®. Since devices of dissimilar protocols cannot actively communicate with one another, the new tests address the interference problem at higher levels. Coexistence test is an empirical method to subject a device to unintended signals and observe the result in the devices’ performance of its wireless functionality. Coexistence test methods are defined in ANSI C63.27 (2017 and 2019), refined for medical devices in AAMI TIR69 (2017), and recommended by the US FDA for wireless medical device approval. The operation of wireless devices is specified in ETSI Standard EN 300 328 (for devices using the 2.4 GHz ISM band) and by EN 301 893 (for devices using the 5 GHz RLAN bands). These standards introduce new required behaviors when sensing other users of the radio spectrum, in addition to the previous types of tests for transmitters including power, occupied bandwidth, frequency control, and so forth. New measurements include Adaptivity, Medium Utilization and other measures to reduce collisions between transmissions, regardless of protocols in use. Together, these new tests should improve wireless device operation in crowded environments as commonly found in medical facilities, where both medical and personal portable devices are using the airwaves. Manufacturers of wireless medical devices should find their products are more robust in using the wireless bands increasingly occupied by a wide variety of IoT devices.

Subjects: Medical Electronics

Speaker: Julien Sarrade (Keysight Technologies)

Type: Lecture

Speech: English

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The ISM bands at 2.4 and 5 GHz receive a lot of attention and use, but bands at 438 and 915 MHz and other frequencies are also used for longer range ambulatory medical devices. As the use of the common wireless radio bands has grown, congestion of these bands is causing failure of wireless communications, a problem that is intermittent and hard to trace. No frequency band or protocol is immune to disruption of communications due to interference. To address the problems of congestion, standards bodies and regulatory agencies have produced recommendations and regulations to test wireless devices for robust operation in the presence of other signals, and to improve wireless device operation by setting standards for device behaviors. These tests and regulations go beyond the previous versions and require new on-the-air behavior which is intended to improve inter-device cooperation to reduce data loss and improve reliability and throughput of devices. Part of the improvement will come as devices are tested for ability to continue operation in the presence of dissimilar on-the-air protocols, such as Bluetooth®, WLAN and ZigBee®. Since devices of dissimilar protocols cannot actively communicate with one another, the new tests address the interference problem at higher levels. Coexistence test is an empirical method to subject a device to unintended signals and observe the result in the devices’ performance of its wireless functionality. Coexistence test methods are defined in ANSI C63.27 (2017 and 2019), refined for medical devices in AAMI TIR69 (2017), and recommended by the US FDA for wireless medical device approval. The operation of wireless devices is specified in ETSI Standard EN 300 328 (for devices using the 2.4 GHz ISM band) and by EN 301 893 (for devices using the 5 GHz RLAN bands). These standards introduce new required behaviors when sensing other users of the radio spectrum, in addition to the previous types of tests for transmitters including power, occupied bandwidth, frequency control, and so forth. New measurements include Adaptivity, Medium Utilization and other measures to reduce collisions between transmissions, regardless of protocols in use. Together, these new tests should improve wireless device operation in crowded environments as commonly found in medical facilities, where both medical and personal portable devices are using the airwaves. Manufacturers of wireless medical devices should find their products are more robust in using the wireless bands increasingly occupied by a wide variety of IoT devices.

Julien Sarrade

Julien Sarrade

Keysight Technologies

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Informations

Julien Sarrade
Julien Sarrade
IoT Business Development Manager, EMEAI

Location

Eingang
Nord-West
ICM
Eingang
Nord
Eingang
West
Atrium
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Nord-Ost
Eingang
Ost
Conference
Center Nord
Freigelände
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B0
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