{"id":639105,"date":"2024-11-06T01:10:05","date_gmt":"2024-11-06T01:10:05","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-tr-12417-22017\/"},"modified":"2024-11-06T01:10:05","modified_gmt":"2024-11-06T01:10:05","slug":"iso-tr-12417-22017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-tr-12417-22017\/","title":{"rendered":"ISO\/TR 12417-2:2017"},"content":{"rendered":"

ISO\/TR 12417-2:2017 provides region-specific information for<\/p>\n

– local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world;<\/p>\n

– changes related to the drug containing part and how they are evaluated by the different local regions.<\/p>\n

For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.<\/p>\n

ISO\/TR 12417-2:2017 is considered also as a supplement to ISO 12417-1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.<\/p>\n","protected":false},"excerpt":{"rendered":"

Cardiovascular implants and extracorporeal systems \u2014 Vascular device-drug combination products \u2014 Part 2: Local regulatory information<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ISO<\/b><\/a><\/td>\n2017-11<\/td>\n36<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":639119,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2634],"product_tag":[],"class_list":{"0":"post-639105","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-40","7":"product_cat-iso","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\/639105","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\/639119"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=639105"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=639105"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=639105"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}