DIN Standards Committee Optics and Precision Mechanics
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
Abstract
This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes: a) a classification of medical 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 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 the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
Begin
2024-11-04
WI
00206111
Planned document number
DIN EN ISO 10993-4
Project number
02703457
Responsible national committee
NA 027-07-12 AA - Biological evaluation of medical devices
Responsible european committee
CEN/TC 206 - Biological and clinical evaluation of medical devices
Responsible international committee
ISO/TC 194/WG 9 - Effects on blood
