ANSI/AAMI/ISO 10993-4-2002 pdf download.Biological evaluation of medical devices — Part 4: Selection of tests for interaction with blood.
This part of ISO 1 0993 provides general requirements for evaluating the interactions of medical devices with blood.
It describes
a) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 1 0993-1 ;
b) the fundamental principles governing the evaluation of the interaction of devices with blood; and
c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.
Detailed requirements for testing cannot be specified because of limitations in knowledge and precision of tests for interactions of devices with blood. This part of ISO 1 0993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 1 0993. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 1 0993 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references,the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
ISO 1 0993-1 :1 997, Biological evaluation of medical devices—Part 1: Evaluation and testing.
ISO 1 0993-2:1 992, Biological evaluation of medical devices—Part 2: Animal welfare requirements.
3 Terms and definitions
For the purposes of this part of ISO 1 0993, the terms and definitions given in ISO 1 0993-1 and the following apply.
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 contains further information on these interactions.
3.2 ex vivo: 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 into test tubes for evaluation (single pass).
3.3 thrombosis: In vivo phenomenon resulting in the partial or complete occlusion of a vessel or device by a thrombus.
NOTE 1 —Characterization of thrombosis includes ex vivo and in vivo methods, in either animals or the clinical setting.
NOTE 2—A thrombus is composed of a mixture of red cells, aggregated platelets, fibrin, and other cellular elements.
3.4 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.ANSI/AAMI/ISO 10993-4 pdf download.