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AAMI 25539-2
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AAMI 25539-2 2012 Edition, January 1, 2012 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
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Description / Abstract:
This part of ISO 25539 specifies requirements for vascular
stents, based upon current medical knowledge. With regard to
safety, it gives requirements for intended performance, design
attributes, materials, design evaluation, manufacturing,
sterilization, packaging and information supplied by the
manufacturer. It 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 part of ISO 25539 and in some cases due to the relatively recent development of some of these implants (e.g. bioabsorbable stents, polymeric stents), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this part of ISO 25539 will be necessary.
The scope of this part of ISO 25539 includes vascular stents used to treat vascular lesions or stenosis, or other vascular abnormalities. These devices might or might not incorporate surface modifications of the stent such as drug and/or other coatings. Stents covered with materials that significantly modify the permeability of the uncovered stent are within the scope of ISO 25539-1. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1 and this part of ISO 25539.
Delivery systems are included in this part of ISO 25539 if they comprise an integral component of the deployment of the vascular stent.
Procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices, are excluded from the scope of this part of ISO 25539.
Some pharmacological aspects of drug-eluting stents are addressed in this part of ISO 25539, but this part of ISO 25539 is not comprehensive with respect to the pharmacological evaluation of drugeluting stents.
Degradation and other time-dependent aspects of bioabsorbable and polymeric stents and coatings are not addressed by this part of ISO 25539.
With the exception of sterilization, this part of ISO 25539 does not address requirements for the evaluation of animal tissue products.
NOTE Due to the variations in the design of implants covered by this part of ISO 25539 and in some cases due to the relatively recent development of some of these implants (e.g. bioabsorbable stents, polymeric stents), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this part of ISO 25539 will be necessary.
The scope of this part of ISO 25539 includes vascular stents used to treat vascular lesions or stenosis, or other vascular abnormalities. These devices might or might not incorporate surface modifications of the stent such as drug and/or other coatings. Stents covered with materials that significantly modify the permeability of the uncovered stent are within the scope of ISO 25539-1. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1 and this part of ISO 25539.
Delivery systems are included in this part of ISO 25539 if they comprise an integral component of the deployment of the vascular stent.
Procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices, are excluded from the scope of this part of ISO 25539.
Some pharmacological aspects of drug-eluting stents are addressed in this part of ISO 25539, but this part of ISO 25539 is not comprehensive with respect to the pharmacological evaluation of drugeluting stents.
Degradation and other time-dependent aspects of bioabsorbable and polymeric stents and coatings are not addressed by this part of ISO 25539.
With the exception of sterilization, this part of ISO 25539 does not address requirements for the evaluation of animal tissue products.