BS EN ISO 7198:2017

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.