Hemocompatibility of blood contacting medical devices has to be evaluated before their intended application. The International Standard ISO 10993-4, for biological evaluation of medical devices (ISO 10993: Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood), can be used as a directive to evaluate these hemocompatible characteristics.
The standard is applicable to external communicating devices, either with an indirect blood path (e.g. blood collection devices, storage systems) or in direct contact with circulating blood (e.g. catheters, extracorporeal circulation systems), and implant devices (stents, heart valves, grafts). Testing should be performed for five categories, based on primary processes: thrombosis, coagulation, platelets, hematology and complement. In this system all relevant aspects of blood activation are taken into consideration, but, and this is most important, testing should simulate clinical conditions as much as possible.
As one of our experts, Dr Wim van Oeveren, is a member of the ISO committee that drafts and revises the ISO 10993-4 standard, we are very well qualified to help you perform hemocompatibility testing to achieve CE or FDA certification regarding blood compatibility.