ANSI AAMI ISO 10993-4 pdf free download

ANSI AAMI ISO 10993-4 pdf free download.Biological evaluation of medical devices— Part 4: Selection of tests for interactions with blood.
Replace the last paragraph with the following: “Detailed requirements for testing cannot be specified because of the limitations in knowledge and precision of tests for interactions of devices with blood. Further, this part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The selection and design of test methods 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.” Pages 1 and 2, Clause 3 Replace the whole clause with the following:
3.1 blood/device interaction any interaction between blood or any component of blood and a device resulting in effects on the blood, or on any organ or tissue or on the device NOTE Such effects may or may not have clinically significant or undesirable consequences. Annex A comprises informative text that contains further information on these interactions. 3.2 coagulation phenomenon that results from activation of the clotting factor cascade NOTE Factors of the coagulation cascade and fibrinolytic systems can be measured following exposure to devices either in vitro or in vivo. 3.3 complement system part of the innate immune system consisting of several plasma proteins, including enzymes and cellular receptors NOTE Effector molecules produced from complement components are involved in inflammation, phagocytosis, and cell lysis.
3.4 embolization process whereby a blood clot, or foreign object, is carried in the bloodstream and which may become lodged and cause obstruction downstream 3.5 ex vivo test system term applied to a test system that shunts blood directly from a human subject or test animal into a test chamber located outside the body NOTE If using an animal model, the blood may be shunted directly back into the animal (recirculating) or collected in test tubes for evaluation (single pass). In either case, the test chamber is located outside the body. 3.6 hematology study of blood that includes quantification of cellular and plasma components of the blood 3.7 platelets anuclear, cellular body that is present in the circulation and which adheres to surfaces and aggregates to form a haemostatic plug to minimize bleeding NOTE Platelet testing includes quantification of platelet numbers as well as analysis of their structure and function. The testing can include analysis of platelet factors, or components on the platelet surface, which are released from platelets or are adherent to the device surface. 3.8 thrombosis in-vivo or ex-vivo phenomenon occurring in flowing whole blood involving activation of the coagulation system and platelets, which results in thrombus formation 3.9 thrombus coagulated mixture of red cells, aggregated platelets, fibrin and other cellular elements 3.10 thromboembolization dislodged thrombus which flows downstream and may cause subsequent vascular blockage or occlusion Page 5, subclause 6.1.7 Delete the whole clause and renumber 6.1.8 to 6.1.14 as 6.1.7 to 6.1.13. New subclause 6.1.7 Replace the whole clause with the following: “The recommendations in 6.1.5 and 6.1.6, together with Clause 5, Figure 1, and Table 2 serve as a guide for the selection of tests listed in 6.2.1. Guidance on pre-clinical evaluations is given in Annex A. The following procedure shall be performed: a) determine which of the 5 potential blood interaction categories are appropriate to the device.ANSI AAMI ISO 10993-4 pdf download.