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VDI 5700 Blatt 3 Hazards in medical areas - Risks of detectable surface changes on invasive medical devices - Measures for risk control

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German title
Gefährdungen bei der Aufbereitung - Risiken von erkennbaren Oberflächenveränderungen an invasiven Medizinprodukten - Maßnahmen zur Risikobeherrschung
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Engl. VDI-Gesellschaft Technologies of Life Sciences
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German, English

Testing for cleanliness and integrity of invasive medical device surfaces (e.g. surgical instruments, endoscopes) is part of the reprocessing process. Hazards must be identified and risks assessed in order to decide whether the concerned medical device can be further used. Manufacturers are obliged to provide information about hazards and risks in the operating instructions. A possible testing result of medical devices may show surface modifications that might cause functional limitations or bear other risks. So far, there have been different evaluation criteria in practice. Based upon VDI 5700 Part 1 this standard provides recommendations to those who need to recognise or become aware of changes to the surface of invasive, reprocessable medical devices and decide about its further use in a reprocessing process or its further use after application.

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