Safety for Electrical Medical Devices - Short course

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  • Опубликовано: 25 июл 2024
  • This is a short course on safety for electrical medical devices. The goal is for you to get an understanding of what basic safety for medical devices is and why you should care about it and improve your chances of not ending up in projects that are behind schedule and over budget.
    The short course is also a preview of the full online course "Introduction to Safety for Electrical Medical Devices and IEC 60601" which is available at:
    medicaldevicehq.com/60601
    Starting October 2023, the templates mentioned in the video are no longer available for free on Medical Device HQ. However, more comprehensive paid versions are now accessible via this link:
    medicaldevicehq.com/templates/
    We offer premium templates for free to our newsletter subscribers. Instant access to some templates is granted upon subscription. Others will be distributed periodically as part of our newsletter email campaigns.
    Chapters:
    00:00 Introduction
    00:36 About the instructor
    01:29 Learning goals of the short course
    02:20 Introduction to safety for electrical medical devices
    03:16 The general standard IEC 60601-1
    03:38 The IEC 60601 collateral standards
    04:08 Particular standards apply to specific medical devices
    04:38 Detailed requirements
    06:55 The ISO 14971 definition of safety
    07:12 The definition of basic safety
    07:32 The definition of essential performance
    08:27 Start safety-related activities early to avoid delays and extra costs
    09:39 Identify critical product features
    11:51 Additional help and resources
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