{"id":25284,"date":"2024-10-17T00:24:18","date_gmt":"2024-10-17T00:24:18","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/astm-f2394-2007-2\/"},"modified":"2024-10-24T13:38:45","modified_gmt":"2024-10-24T13:38:45","slug":"astm-f2394-2007-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/astm\/astm-f2394-2007-2\/","title":{"rendered":"ASTM-F2394 2007"},"content":{"rendered":"
\n Significance and Use <\/b><\/p>\n

The securement of the endovascular stent on the balloon is a critical parameter to ensure that the stent is safely delivered to or from the treatment site.<\/p>\n

This guide is intended for use by researchers and manufacturers for the development and selection of pre-test treatments, tests and test endpoints to measure stent securement (displacement distances and dislodgment forces).<\/p>\n

This guide may be used to investigate which practical combinations of in vitro <\/span> tests best characterize clinical scenarios.<\/p>\n

This guide should be used with discretion in choosing securement tests and evaluating results due to the myriad possible combinations of clinical conditions, failure modes, and stent delivery system designs.<\/p>\n

This guide may be of use for developing a test for meeting parts 2 and 3 of the requirements of EN 14299, Section 7.3.4.4 on Trackability.<\/p>\n

This guide may be of use for developing a test to meet section VII-C-8 of CDRH Guidance document.<\/p>\n

1. Scope <\/b><\/p>\n

1.1 This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems.<\/p>\n

1.2 This guide covers the laboratory determination of the shear force required to displace or dislodge a balloon-expandable endovascular stent mounted on a delivery system. The guide proposes a set of options to consider when testing stent securement. The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. An example test apparatus is given in .<\/p>\n

1.3 This guide covers in vitro bench testing characterization only. Measured levels of securement and product design\/process differentiation may be particularly influenced by selections of pre-test treatments, securement test type (for example, stent gripping method), and test endpoint. In vivo characteristics may also differ from in vitro results.<\/p>\n

1.4 This guide does not cover all possible pre-test treatments, stent securement tests, or test endpoints. It is intended to provide a starting point from which to select and investigate securement test options.<\/p>\n

1.5 This guide does not specify a method for mounting the stent onto the delivery system.<\/p>\n

This standard does not purport to address all of the<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

F2394-07 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System (Redline)<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ASTM<\/b><\/a><\/td>\n2007<\/td>\n15<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":25285,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2637],"product_tag":[],"class_list":{"0":"post-25284","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-astm","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/25284","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\/25285"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=25284"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=25284"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=25284"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}