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Norm

ISO 10993-4:2017

Ausgabedatum: 2017 04 12

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

ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that...
Gültig
Herausgeber:
International Organization for Standardization
Format:
Digital | 69 Seiten
Sprache:
Englisch

ISO 10993-4:2017 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.

ISO 10993-4:2017
2017 04 12
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
Norm
ISO 10993-4:2002/Amd 1:2006
2006 07 21
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — ...
Norm
ISO 10993-4:2002
2002 10 22
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
Norm
ISO 10993-4:1992
1992 12 30
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
Norm
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