Biocompatibility

A Biological Evaluation Plan to ISO 10993-1:2025: the risk-based document that categorises your device, identifies every patient-contacting material, sets the endpoints to be addressed and decides — before anything is ordered — which are met by testing, which by literature and existing data, and which can be justified away.

A Biological Evaluation Report to ISO 10993-1:2025: the document that closes the evaluation by gathering every test result, literature justification and existing dataset against the endpoints set in the plan, and states the biological safety conclusion for the device.

Evaluation of one additional patient-contacting category under ISO 10993-1:2025, extending a biological evaluation plan or report to a second contact type or duration — for example a device that contacts both intact skin and circulating blood.

A structured literature search and endpoint-risk evaluation for one additional patient-contacting material, extending the five materials included in the base Biological Evaluation Plan.

Assessment of a device, packaging or manufacturing change against an existing biological evaluation, using the ISO 10993-1 decision framework, concluding whether the change affects biocompatibility and what, if anything, needs to be re-tested.