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. The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.

Begin

2023-04-27

WI

00206099

Planned document number

DIN EN ISO 10993-4/A1

Project number

02703400

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  

draft standard

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024); German and English version EN ISO 10993-4:2017/prA1:2024
2024-04
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previous edition(s)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
2017-12

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