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ISO DIS 7198 2014 Edition, July 3, 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES
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Description / Abstract:
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.
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.
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.
Vascular prostheses that are made of synthetic textile
materials, and synthetic nontextile materials are within the scope
of this standard.
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 standard
does not address sourcing, harvesting, manufacturing and all
testing requirements for biological materials. It is further noted
that different regulatory requirements may exist for tissues from
human and animal sources.
Compound, coated, composite, and externally reinforced vascular
prostheses are within the scope of this standard.
Endovascular prostheses implanted using catheter delivery and
non-direct visualization are excluded from the scope of this
standard. This standard includes information on the development of
appropriate test methods for graft materials, referenced in ISO
25539-1 for materials used in the construction of endovascular
prostheses (i.e., stent-grafts).
NOTE Requirements for endovascular prostheses are specified in
ISO 25539-1.
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 standard. This 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.
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
standard.
NOTE Requirements for vascular stents are specified in ISO
25539-2.
Requirements regarding cell seeding are excluded from the scope
of this standard. Tissue engineered vascular grafts 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 nonviable biological
materials. The in vitro testing requirements that are outlined in
this standard may be a useful guide for certain testing
requirements for these cell-based products.
Pharmacological aspects of drug eluting or drug coated vascular
prostheses are not addressed in this standard.
NOTE Requirements for vascular device-drug combination products
are specified in ISO TS 12417.
Degradation, tissue ingrowth and/or tissue replacement, and
other time-dependent aspects of absorbable vascular prostheses are
not addressed in the standard.