標(biāo)準(zhǔn)號(hào)：ANSI/AAMI/ISO 14708-4-2008
中文標(biāo)準(zhǔn)名稱：外科植入物.有源可植入醫(yī)療設(shè)備.第4部分:可植入輸液泵
英文標(biāo)準(zhǔn)名稱：Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
標(biāo)準(zhǔn)類型：C45
發(fā)布日期：1999/12/31 12:00:00
實(shí)施日期：1999/12/31 12:00:00
中國標(biāo)準(zhǔn)分類號(hào)：C45
國際標(biāo)準(zhǔn)分類號(hào)：11.040.40
適用范圍：This part of ISO 14708 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices as defined in Clause 3. The tests that are specified in this part of ISO 14708 are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.