Biocompatibility Archives

New Guidance on FDA ISO 10993-1

By James Morrison | 14 September 2020

On 4 September 2020 FDA re-issued their guidance on the use of ISO 10993-1 and Biocompatibility. I don’t think anyone saw this coming. It’s a big surprise! But the good...

Chemical Characterisation – no simple matter

By James Morrison | 28 August 2020

Understanding Chemistry is now mandatory The most recent edition of ISO 10993-1 in 2018 added to the evaluation table (Table A.1) the interesting item “Physical and/or chemical information.” This is...

Test or Evaluate? Biocompatibility and Orthopaedic materials

By Arthur Brandwood | 3 June 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...

Biocompatibility of Breathing Gas Pathways

By Arthur Brandwood | 5 August 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...