Ethylene oxide (EO) is the most common medical device sterilization modality. About 50 percent of sterile medical devices on the market are sterilized with EO.
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His name may not carry the notoriety of Robert Jones, Hugh Owen Thomas, or even Sir John Charnley, but Duncan Dowson is nevertheless an orthopedic icon in his own right.
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While you may not want to think of the words “worst case” relating to your product, these words are critical in designing a chemical-characterization study and assessing those results in a toxicological-risk assessment.
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According to ISO 10993-1:2018, “the biological evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971.”
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ISO 17664:2017 provides guidance on this issue and states that “At least one validated automated cleaning method (which may include a validated manual cleaning method as part of the automated cleaning validation) shall be specified unless the medical device cannot withstand any such process, in which case a statement shall be provided which alerts the user to this issue.”
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Particulate testing is required for medical devices to ensure patient safety, but there isn’t a lot of guidance available. Here are four important things you need to know about particulate testing on medical devices.
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