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About This Item
Full Description
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.
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.
Document History
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BS EN ISO 10993-4:2017
viewing
Biological evaluation of medical devices-Selection of tests for interactions with blood- Most Recent
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BS EN ISO 10993-4:2009
Biological evaluation of medical devices-Selection of tests for interactions with blood- Historical Version
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BS EN ISO 10993-4:2002
Biological evaluation of medical devices-Selection of tests for interactions with blood- Historical Version
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BS EN 30993-4:1994
Biological evaluation of medical devices-Selection of tests for interactions with blood- Historical Version
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BS 5736-11:1990
Evaluation of medical devices for biological hazards-Method of test for haemolysis- Historical Version