{"id":593303,"date":"2024-11-05T21:30:15","date_gmt":"2024-11-05T21:30:15","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-14708-52020\/"},"modified":"2024-11-05T21:30:15","modified_gmt":"2024-11-05T21:30:15","slug":"iso-14708-52020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-14708-52020\/","title":{"rendered":"ISO 14708-5:2020"},"content":{"rendered":"
This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements.<\/p>\n
NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.<\/p>\n
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products.<\/p>\n
Included in the scope of this document are:<\/p>\n
\u2014 ventricular assist devices (VAD), left or right heart support;<\/p>\n
\u2014 total artificial hearts (TAH);<\/p>\n
\u2014 biventricular assist devices (biVAD);<\/p>\n
\u2014 percutaneous assist devices;<\/p>\n
\u2014 paediatric assist devices.<\/p>\n","protected":false},"excerpt":{"rendered":"
Implants for surgery \u2014 Active implantable medical devices \u2014 Part 5: Circulatory support devices<\/b><\/p>\n\n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n ISO<\/b><\/a><\/td>\n 2020-05<\/td>\n 78<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":593318,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2634],"product_tag":[],"class_list":{"0":"post-593303","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\/593303","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\/593318"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=593303"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=593303"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=593303"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}