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Technical rule [CURRENT]

VDI 5707 Blatt 1:2023-02

Retesting of active medical devices in medical use - Testing principles

German title
Wiederholungsprüfungen an aktiven Medizinprodukten im medizinischen Einsatz - Prüfgrundlagen
Publication date
2023-02
Original language
German, English
Pages
58

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Publication date
2023-02
Original language
German, English
Pages
58

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Short description
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.
Content
ICS
11.040.01
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