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 standard. This standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. This standard is supplemental to ISO 14630, 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 document will be necessary.
1.2 This International Standard includes is applicable to sterile tubular vascular prostheses 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 nontextile materials are included in thewithin the scope of this 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, thise standard does not specifically address sourcing, harvesting, and manufacturing and all testinfg requirements for biological materials. It is further noted that different regulatory requirements may exist for tissues from human and animal sources.
Registration number (WIID)
41212
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 standard. This standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. This standard is supplemental to ISO 14630, 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 document will be necessary.
1.2 This International Standard includes is applicable to sterile tubular vascular prostheses 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 nontextile materials are included in thewithin the scope of this 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, thise standard does not specifically address sourcing, harvesting, and manufacturing and all testinfg requirements for biological materials. It is further noted that different regulatory requirements may exist for tissues from human and animal sources.
