EN 30993-4:1993

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:1992)

General information

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

Scope

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.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 30993-4:1993
99.60 Withdrawal effective
Oct 15, 2002

REVISED BY

WITHDRAWN
EN ISO 10993-4:2002

Relations

Adopted from ISO 10993-4:1992 IDENTICAL