99.60 Withdrawal effective Oct 15, 2002
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
11.040.01 Medical equipment in general | 11.060.10 Dental materials | 11.120.01 Pharmaceutics in general
This part of ISO 10993 provides a guide for agencies, manufacturers, research laboratories and others for evaluating the interactions of medical and dental materials and 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 10993-1; b) the fundamental principles governing the evaluation of the interaction of devices with blood; c) the rationale for structured selection of tests, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of the limitations in knowledge and precision of tests for interactions of devices with blood.
Legislation related to this standard
WITHDRAWN
EN 30993-4:1993
99.60
Withdrawal effective
Oct 15, 2002
WITHDRAWN
EN ISO 10993-4:2002
