{"id":362160,"date":"2024-10-20T01:39:20","date_gmt":"2024-10-20T01:39:20","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-20-30400340-dc-2020\/"},"modified":"2024-10-26T02:35:31","modified_gmt":"2024-10-26T02:35:31","slug":"bsi-20-30400340-dc-2020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-20-30400340-dc-2020\/","title":{"rendered":"BSI 20\/30400340 DC 2020"},"content":{"rendered":"<p>Part 4 of <span class=\"std\"><span class=\"std-ref\">ISO&nbsp;25539<\/span><\/span> specifies the appropriate application of <span class=\"std\"><span class=\"std-ref\">ISO 17327-1:2018<\/span><\/span>, <i>Non-active surgical implants \u2014 Implant coating \u2014Part 1: General requirements,<\/i> to coated endovascular prostheses, vascular stents, and vena cava filters. Part 4 of <span class=\"std\"><span class=\"std-ref\">ISO&nbsp;25539<\/span><\/span> should be considered as a supplement to <span class=\"std\"><span class=\"std-ref\">ISO&nbsp;25539-1<\/span><\/span>, <span class=\"std\"><span class=\"std-ref\">ISO&nbsp;25539-2<\/span><\/span>, <span class=\"std\"><span class=\"std-ref\">ISO 25539-3<\/span><\/span>, <span class=\"std\"><span class=\"std-ref\">ISO 12417-1<\/span><\/span> and <span class=\"std\"><span class=\"std-ref\">ISO 17137<\/span><\/span>.<\/p>\n<p>The following coatings are within the scope of <span class=\"std\"><span class=\"std-ref\">ISO 17327-1<\/span><\/span> and addressed in this standard for endovascular devices: drug coatings (eluting and non-eluting), non-drug coatings (absorbable and non-absorbable), and chemistry-related surface modifications (oxide(e.g. TiO<sub>2<\/sub>) and non-oxide(e.g. amorphous silicon carbide, diamond-like carbon)).<\/p>\n<p>This standard is not applicable to coated delivery systems or coated ancillary devices (e.g. guidewires), as these coatings are not within the scope of <span class=\"std\"><span class=\"std-ref\">ISO 17327-1<\/span><\/span>, which is specifically directed to implant coatings.<\/p>\n<p>This document is not applicable to coverings of endovascular devices; however, if the covering of a device is coated it is within the scope of this part of <span class=\"std\"><span class=\"std-ref\">ISO 25539<\/span><\/span>.<\/p>\n<p>This standard does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used as implant coatings.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>BS ISO 25539-4. Cardiovascular implants. Endovascular devices &#8211; Part 4. Application of ISO 17327-1 for coated endovascular devices<\/b><\/p>\n<table class=\"shortdes-table\" style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/bsi\/\"><b>BSI<\/b><\/a><\/td>\n<td>2020<\/td>\n<td>20<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":362170,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-362160","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-40","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/362160","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/362170"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=362160"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=362160"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=362160"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}