Biocompatibility

hip joints

Test or Evaluate? Biocompatibility and Orthopaedic materials

This morning, the US FDA announced with a tweet, the publication of a new guidance on Ultra High Molecular Weight Polyethylene (UHMWPE) in Orthopaedic devices. "Manufacturers should include test data...
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FDA and ISO stars aligning on ISO 10993

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Ventilator patient

Biocompatibility of Breathing Gas Pathways

ISO 10993-1 requires that devices which contact the body indirectly - by means of a fluid or gas passed through the device and into the patient - must be assessed...

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