ISO 25539-2-2012 pdf free download.Cardiovascular implants – Endovascular devices – Part 2: Vascular stents Part 2: Vascular stent.
1.1 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. bloabsorbable 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.
1.2 The scope of this part of ISO 25539 includes vascular stents used to treat vascular lesions or stenoses, 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.
1.3 Delivery systems are included in this part of ISO 25539 if they comprise an integral component of the deployment of the vascular stent.
1.4 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.
1.5 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 drug-eluting stents.
1.6 Degradation and other time-dependent aspects of bioabsorbable and polymeric stents and coatings are not addressed by this part of ISO 25539.
1.7 With the exception of sterilization, this part of ISO 25539 does not address requirements for the evaluation of animal tissue products.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development. validation and routine control of a sterilization process for medical devices.ISO 25539-2 pdf download.