Home Discussions Ask a Question Medical Devices Questions How do I assess the biocompatibility of a medical device that is intended to be

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  • #14858 Score: 0

    Edward Gonzalez
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    I’m trying to figure out how I would assess the biocompatibility of a medical device that is intended to be used for 45 days? If anyone has any advice/insight on this that would be great! Thanks.

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  • #16210 Score: 2
    Andreas Reyez
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    The ISO 10993 series of standards outline the ways in which medical device companies are required to test their products for biocompatibility. Depending on whether the device is surface-contacting only, or is an implant, the FDA and other regulators require a number of toxicity tests to be performed.

    In your case, a device that’s intended to be used for 45 days is considered to be a “permanent device” which means you’ll likely need to perform additional testing. If your product is an implantable device, you’ll need to conduct the most extensive compatibility testing from assessing the cytotoxicity and sensitization all the way to hemocompatibiltiy and carcinogenicity.

    Hope this helps!

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