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In Vivo Test Requirement

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Guest user Created:   Feb 28, 2022 Last commented:   Mar 02, 2022

In Vivo Test Requirement

I have a question about in vivo test requirement. As you know our product *** is class-III and we need if in vivo test is mandatory for bio-compatibility. If you can answer this we will be glad.
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Kristina Zvonar Brkić Mar 02, 2022

For biocompatibility, in vivo testing are necessary considering the type of the product. In ISO 10993-1:2018, there is a table that guides what tests are necessary depending on the type of the product: is it a surface device, external communicated device, or implantable device. So, which kind of tests are necessary for you, you need to go through that table. 

For more information, see this link: https://www.iso.org/standard/68936.html
 

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Mar 02, 2022