ISO 10993-4:2002

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

Publication date:   Oct 22, 2002

95.99 Withdrawal of Standard   Apr 12, 2017

General information

95.99 Withdrawal of Standard   Apr 12, 2017

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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Scope

ISO 10993-4:2002 provides general requirements for evaluating the interactions of medical devices with blood.
It describes
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,the fundamental principles governing the evaluation of the interaction of devices with blood,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 interactions of devices with blood. ISO 10993-4:2002 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10993-4:1992

NOW

WITHDRAWN
ISO 10993-4:2002
95.99 Withdrawal of Standard
Apr 12, 2017

CORRIGENDA / AMENDMENTS

WITHDRAWN
ISO 10993-4:2002/Amd 1:2006

REVISED BY

ABANDON
ISO/WD 10993-4

PUBLISHED
ISO 10993-4:2017