Presentation 153 - 医疗和物联网设备之间的医疗无线共存.pdfVIP

How will you handle the Medical Wireless Coexistence Between Medical and IoT Devices? Chris, KELLY 2018.02.27 Kah-Meng (KM), CHEW 2018.02.27 Industry Application Specialist Industry Solutions Manager Agenda • History of Wireless Medical Devices and the FDA concern • Recent Events in Regulatory Standards • What is RF Coexistence Testing? • How is RF Coexistence Testing performed? 2 FDA approval process is often not the bottleneck Typical timeline of Medical Device development • Device prototyping: 2–5 weeks • Feasibility testing in the lab: 1–2 weeks • Use case validation in the field: More than a year • Independent clinical validation: More than 6 months • FDA approval (510K): 3–9 months 3 Wireless Coexistence Today’s Topic: Only one aspect of the FDA Wireless Guidance Selection and performance of Wireless Quality of Service wireless Coexistence technology EMC of the Information for Security of Wireless Proper Set-up and Wireless Signals Technology Operation and Data Considerations for Maintenance 4 The Need for Coexistence Testing The FDA work began in 2007 and issued first Guidance in 2013 “If the RF wireless medical device is expected to be used in proximity to other RF wireless in-band (i.e., the same or nearby RF frequency) sources, FDA recommends addressing such risks through testing for coexistence of the device wireless system in the presence of the number and