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DIN/TS 5343:2022
Cleanliness of medical devices - Risk orientated validation of cleanliness, development of acceptance criteria and selection of test methods; Text in German and English
This document specifies requirements to ensure the required cleanliness of medical devices in their delivery state. In addition, this document specifies requirements to ensure the cleanliness of medical devices required for further steps in the manufacturing process which are necessary to produce a safe medical device. Processes which are carried out after opening the original packaging of the medical device are not covered by this document.
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Deutsches Institut für Normung [din]
