ISO 7198:2016 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.

compliance to maintain permeability after implantation can be taken into account; the requirements adequate of ISO 10993-1 and structural and other integrity; parts of the ISO 10993 series.

It is an update of ISO 7198:1998, necessary given the introduction of new standards for endovascular prostheses and vascular device-drug combination products. This standard covers vascular prostheses implanted using direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g., computerized tomography or ...

This International Standard is an update of ISO 7198:1998, necessary given the introduction of new standards for endovascular prostheses, vascular stents and vascular device-drug combination products.

ISO 7198 has been prepared in order to provide basic requirements for sterile vascular prostheses and the methods of test which will enable evaluation of vascular prostheses.

Cardiovascular implants - Tubular vascular prostheses. Specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and …

2016年8月1日 · This International Standard includes information on the development of appropriate test methods for graft materials, referenced in ISO 25539-1 for materials used in …

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.