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Programmable electronic medical systems – related risks …

    https://journals.sagepub.com/doi/abs/10.1177/146045820200800204
    Programmable electronic medical systems – related risks and learning from accidents F. Koornneef , U. Voges First Published June 1, 2002 Research Article https://doi.org/10.1177/146045820200800204 Article information Abstract The application …

Improved certification of medical software with AI

    https://www.medica-tradefair.com/en/Archive/Improved_certification_of_medical_software_with_AI
    To shorten the time from development to certification, the KIMEDS joint project aims to develop an AI-supported safety solution across the entire lifecycle of medical software. …

IEC 60601-1-4 - Medical Electrical Equipment - GlobalSpec

    https://standards.globalspec.com/std/594957/IEC%2060601-1-4
    This Collateral Standard applies to the SAFETY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS incorporating PROGRAMMABLE …

Programmable electronic medical systems – related risks …

    https://www.semanticscholar.org/paper/Programmable-electronic-medical-systems-%E2%80%93-related-Koornneef-Voges/7fff153ce2784541448f6cd83612382e54f9c402
    Health Informatics Journal. The application of medical devices is often combined with some risk. This risk needs to be evaluated and compared with the …

What does the Programmable Electrical Medical System really …

    https://elsmar.com/elsmarqualityforum/threads/what-does-the-programmable-electrical-medical-system-really-mean.49875/
    1) CPU (maybe sometimes simply single chip) 2) software. 3)If the software penetrates to essential performance (EP) or basic safety (BS) therefore, to …

Overview of IEC 60601-1 Terminology

    https://starfishmedical.com/blog/iec-60601-1-terminology-thru-annexes/
    Section 14 Programmable Electrical Medical Systems (PEMS) covers the broad topic of safety in devices containing firmware or software. One big …

IEC 60601-1 Programmable Electrical Medical Systems

    https://www.biomedicalviews.com/2022/05/iec-60601-1-programmable-electrical.html
    Programmable Electrical Medical Systems intended to be incorporated into an IT-Network: If the PEMS is intended to be incorporated into an IT-Network which …

MD and IVD standards: IEC 60601-1 and …

    https://blog.cm-dm.com/post/2013/04/04/IEC-62304-vs-IEC-60601-1-and-IEC-61010
    System on a Chip (SoC), Micro-controllers and C (or else) programs Quick answer: apply IEC 60601-1 if program is tiny enough, otherwise apply IEC 62304. If …

Chapter 9: Programmable Electronic Systems | GlobalSpec

    https://www.globalspec.com/reference/57772/203279/chapter-9-programmable-electronic-systems
    The majority of modern control systems today are programmable electronic systems (PESs). They are typically supplied with display systems, printers, and communication …

Medical Device Software - an overview | ScienceDirect Topics

    https://www.sciencedirect.com/topics/computer-science/medical-device-software
    The FBI’s concerns, however, go beyond traditional medical devices and include HVAC remotes, security systems, appliances like smart TVs, office equipment …



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