标准号：ISO 25539-2-2008
实施状态：作废
中文名称：心血管植入物.血管内器械.第2部分:血管支架
英文名称：Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
发布日期：2008-09
被替代标准：ISO 25539-2-2012
代替标准：ISO/FDIS 25539-2-2008
采用标准：DIN EN ISO 25539-2-2009,IDT;DIN EN ISO 25539-2-2009,IDT;DIN EN ISO 25539-2/A1-2009,IDT;ANSI/AAMI/ISO 25539-2-2008,IDT;BS EN ISO 25539-2-2009,IDT;BS EN ISO 25539-2-2010,IDT;EN ISO 25539-2-2008,IDT;EN ISO 25539-2-2009,IDT;prEN ISO 25539-2-2008,IDT;NF S94-203-2-2009,IDT;NF S94-203-2-2009,IDT;S94-203-2PR,IDT;SN EN ISO 25539-2-2008,IDT;SN EN ISO 25539-2-2009,IDT;OENORM EN ISO 25539-2-2008,IDT;OENORM EN ISO 25539-2-2009,IDT;PN-EN ISO 25539-2-2009,IDT;PN-EN ISO 25539-2-2009,IDT;UNE-EN ISO 25539-2-2009,IDT;UNE-EN ISO 25539-2 V2-2009,IDT
起草单位：ISO/TC 150
标准简介：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. 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 document 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
document 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.
文件格式：PDF
文件大小：617.24KB
文件页数：100
（以上信息更新时间为：2019-11-22）
ISO 25539-2-2008 心血管植入物.血管内器械.第2部分_血管支架.pdf
(617.24 KB)
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