DS/EN ISO 10993-4:2017

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
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Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


Legislation

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 

Links

Scope

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.


Number of pages: 86

Published: 2017-05-18

Date of approval: 2017-05-16

Date of withdrawal: 2017-10-23

International relationships : EN ISO 10993-4:2017 IDT ISO 10993-4:2017 IDT

ICS: 11.100.20 - Biological evaluation of medical devices

Item number: M301473


Committees

Committee

  • CEN/TC 206
  • ISO/TC 194
  • ISO/TC 194/WG 9

Danish committee

DS/S-258