SR EN 30993-4:1997

Biological evaluation of medical devices. Part 4: Selection of tests for interaction with blood

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.

General information

Status : Withdrawn
Approval date : 3/6/1997
Publish date : 3/7/1997
Withdrawal date : 10/14/2003
Number of pages : 32
ICS : 11.040.01 Medical equipmet in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Normative reference SR EN 30993-1:1996
Replaced by SR EN ISO 10993-4:2003