BS EN 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.


Cross References:
ISO 10993-1:2009 Ed 4
ISO 10993-12:2012 ED4 ISO 10993
93/42/EEC
ANSI/AAMI RD16:2007
ISO 5840
GB/T 16175
ISO/IEC 17025:2005 Ed 1
ISO 15675:2016
ISO 8637:2010 Ed 3
ASTM F1841 - 97(2013)
ASTM F2065 - 00(2010)
ISO 7198:2016
ISO 7199:2016
ASTM F2888 - 13
ISO 3826-3:2006 Ed 1
ISO 15674:2016
ASTM F1984 - 99(2013)
ISO 14708-2:2012
ASTM F2382 - 04(2010)
ASTM F1830 - 97(2013)
ISO 12891-1:2015
ISO 5841-3:2013 ED3
ISO 14708-5:2010 Ed 1


All current amendments available at time of purchase are included with the purchase of this document.