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Biocompatibility

hip joints

Test or Evaluate? Biocompatibility and Orthopaedic materials

By Arthur Brandwood | 06.03.2019
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

By Dave Spicer | 10.18.2018
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Ventilator patient

Biocompatibility of Breathing Gas Pathways

By Arthur Brandwood | 08.05.2018
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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