BS EN ISO 7198:2017

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 ISO14630:2012, 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.

1.2 This International Standard is applicable to sterile tubular vascular grafts implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system.

1.3 Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials are within the scope of this International Standard.

1.4 While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, this International Standard does not address sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is further noted that different regulatory requirements might exist for tissues from human and animal sources.

1.5 Compound, coated, composite, and externally reinforced vascular prostheses are within the scope of this standard.

1.6 Endovascular prostheses implanted using catheter delivery and non-direct visualization are excluded from the scope of this International Standard. This International Standard includes information on the development of appropriate test methods for graft materials, referenced in ISO25539-1 for materials used in the construction of endovascular prostheses (i.e. stent-grafts).

NOTE Requirements for endovascular prostheses are specified in ISO25539-1.

1.7 The valve component of valved conduits constructed with a tubular vascular graft component, and the combination of the valved component and the tubular vascular graft component, are excluded from the scope of this International Standard. This International Standard can be helpful in identifying the appropriate evaluation of the tubular vascular graft component of a valved conduit but specific requirements and testing are not described for these devices.

1.8 Cardiac and pericardial patches, vascular stents, accessory devices such as anastomotic devices, staplers, tunnelers and sutures, and pledgets are excluded from the scope of this International Standard.

NOTE Requirements for vascular stents are specified in ISO25539-2.

1.9 Requirements regarding cell seeding are excluded from the scope of this International Standard. Tissue engineered vascular prostheses that contain or are manufactured using cells present many distinct manufacturing (e.g. aseptic processing, cell seeding, etc.) and testing issues than those produced with synthetic or non-viable biological materials. The in vitro testing requirements that are outlined in this International Standard can be a useful guide for certain testing requirements for these cell-based products.

1.10 Pharmacological aspects of drug-eluting or drug-coated vascular prostheses are not addressed in this International Standard.

NOTE Requirements for vascular device-drug combination products are specified in ISO12417-1.

1.11 Degradation, tissue ingrowth and/or tissue replacement, and other time-dependent aspects of absorbable vascular prostheses are not addressed in the standard.