DIN EN ISO 10993-4:2017-12

This standard has been adopted from the work of ISO/TC 194 Biological and clinical investigation of medical devices. It specifies test methods for assessing the interaction of medical devices with blood. The selection and design of test methods for the interactions of medical devices with blood should take into consideration device design, materials, clinical utility, usage environment and risk benefit. This level of specificity can only be covered in vertical standards. Potential users of this standard are both testing institutes and manufacturers of medical devices. This standard is a test standard and is to be applied in conjunction with DIN EN ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". This standard deals in particular with aspects of quality, health protection and product safety. The responsible committee for this standard is NA 027-02-12 AA "Biologische Beurteilung von Medizinprodukten" ("Biological evaluation of medical devices") at DIN Standards Committee Optics and Precision Mechanics (NAFuO).