1 Scope
1.1 This International Standard 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.