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VDI 5707 Blatt 1 - Draft Retesting of active medical devices in medical use - Testing principles

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German title
Wiederholungsprüfungen an aktiven Medizinprodukten im medizinischen Einsatz - Prüfgrundlagen
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Engl. VDI-Gesellschaft Technologies of Life Sciences
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In the maintenance of active medical devices one encounters a wide variety of maintenance strategies. The primary goal of any maintenance is the safety of the persons, patients, users and third parties handling medical devices. Studies and practical experience show that evidence-based maintenance can be more efficient and economical than strict adherence to manufacturer recommendations. Manufacturers may assume "worst case" conditions. On the other hand, those responsible for carrying out maintenance on behalf of the operators and providing on-site support for the medical equipment can incorporate real usage data with corresponding evidence into their maintenance strategies. The standard presents well-founded recommendations for evidence-based maintenance of active medical devices in clinical use.

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