BS EN ISO 7198:2017 specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this International Standard. This International Standard can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants.

NOTE Due to the variations in the design of implants covered by this International Standard and, in some cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this International Standard will be necessary.


Cross References:
EN ISO 10993-1:2009
ISO 10993-1:2009
EN ISO 10993-2:2006
ISO 10993-2:2006
EN ISO 10993-3:2014
ISO 10993-3:2014
EN ISO 10993-4:2009
ISO 10993-4:2002
ISO 10993-4:2002/A1:2006
EN ISO 10993-5:2009
ISO 10993-5:2009
EN ISO 10993-6:2009
ISO 10993-6:2007
EN ISO 10993-7:2008
EN ISO 10993-7:2008/Corrigendum 1:2009
ISO 10993-7:2008
ISO 10993-7:2008/Corrigendum 1:2009
EN ISO 10993-9:2009
ISO 10993-9:2009
EN ISO 10993-10:2013
ISO 10993-10:2010
EN ISO 10993-11:2009
ISO 10993-11:2006
EN ISO 10993-12:2012
ISO 10993-12:2012
EN ISO 10993-13:2010
ISO 10993-13:2010
EN ISO 10993-14:2009
ISO 10993-14:2001
EN ISO 10993-15:2009
ISO 10993-15:2000
EN ISO 10993-16:2010
ISO 10993-16:2010
EN ISO 10993-17:2009
ISO 10993-17:2002
EN ISO 10993-18:2009
ISO 10993-18:2005
ISO/TS 10993-19:2006
ISO/TS 10993-20:2006
EN ISO 11135:2014
ISO 11135:2014
EN ISO 11137-1:2015
ISO 11137-1:2006
ISO 11137-1:2006/A1:2013
EN ISO 11137-2:2015
ISO 11137-2:2013
EN ISO 11137-3:2006
ISO 11137-3:2006
EN ISO 11607-1:2009
EN ISO 11607-1:2009/A1:2014
ISO 11607-1:2006
ISO 11607-1:2006/A1:2014
EN ISO 14155:2011
EN ISO 14155:2011/Corrigendum 1:2011
ISO 14155:2011
ISO 14155:2011/Corrigendum 1:2011
EN ISO 14160:2011
ISO 14160:2011
ISO 14630:2012
EN ISO 14630:2012
ISO 14630:2012
EN ISO 14937:2009
ISO 14937:2009
EN ISO 14971:2012
ISO 14971:2007
EN ISO 17665-1:2006
ISO 17665-1:2006
CEN ISO/TS 17665-2:2009
ISO/TS 17665-2:2009
93/42/EEC
ISO 12417-1
ISO 13485
ISO 25539-1
ISO 25539-2


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