Describes a classification of medical and dental devices that are intended for use in contact with blood, the fundamental principles governing the evaluation of the interaction of devices with blood, and the rationale for structured selection of tests, together with the principles and scientific basis of these tests. Annex A describes evaluation of cardiovascular devices and prostheses during in vivo function.
Status : WithdrawnPublication date : 1992-12
Edition : 1Number of pages : 19
Technical Committee:Biological and clinical evaluation of medical devices