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Norm

ÖNORM EN ISO 10993-4

Issue date: 2017 11 01

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

This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are...
Withdrawn: 2018 01 01
Publisher:
Austrian Standards International
Format:
Digital | 90 Pages
Language:
German | English | Download GER/ENG
Optionally co-design standards:
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.
ÖNORM EN ISO 10993-4
2018 01 01
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ÖNORM EN ISO 10993-4
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Norm
ISO 10993-1:2018
Issue date : 2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Norm
ÖNORM EN ISO 10993-4
Issue date : 2018 01 01
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Norm
ISO 10993-4:2017
Issue date : 2017 04 12
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood