{"id":198197,"date":"2024-10-19T12:37:01","date_gmt":"2024-10-19T12:37:01","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-14708-4-2008-ra-2011\/"},"modified":"2024-10-25T05:10:11","modified_gmt":"2024-10-25T05:10:11","slug":"aami-14708-4-2008-ra-2011","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-14708-4-2008-ra-2011\/","title":{"rendered":"AAMI 14708 4 2008 RA 2011"},"content":{"rendered":"

Specifies requirements for the safety and performance of active implantable infusion pumps.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 14708-4:2008\/(R)2011, Implants for surgery\u2014Active implantable medical devices\u2014Part 4: Implantable infusion pumps <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of ANSI\/AAMI adoption of ISO 14708-4:2008 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
14<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
15<\/td>\n4 Symbols and abbreviated terms
5 General requirements for non-implantable parts <\/td>\n<\/tr>\n
16<\/td>\n6 Requirements for particular active implantable medical devices
6.101 Implantable infusion pump characteristics
6.102 Septum puncture test <\/td>\n<\/tr>\n
17<\/td>\n7 General arrangement of the packaging
8 General markings for active implantable medical devices <\/td>\n<\/tr>\n
18<\/td>\n9 Markings on the sales packaging
10 Construction of the sales packaging
11 Markings on the sterile pack <\/td>\n<\/tr>\n
19<\/td>\n12 Construction of the non-reusable pack
13 Markings on the active implantable medical device
14 Protection from unintentional biological effects caused by the active implantable medical device <\/td>\n<\/tr>\n
20<\/td>\n15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device <\/td>\n<\/tr>\n
21<\/td>\n16 Protection from harm to the patient caused by electricity
17 Protection from harm to the patient caused by heat
18 Protection from ionizing radiation released or emitted from the active implantable medical device
19 Protection from unintended effects caused by the device <\/td>\n<\/tr>\n
22<\/td>\n20 Protection of the device from damage caused by external defibrillators
21 Protection of the device from changes caused by high-power electrical fields applied directly to the patient
22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments <\/td>\n<\/tr>\n
23<\/td>\n23 Protection of the active implantable medical device from mechanical forces
24 Protection of the active implantable medical device from damage caused by electrostatic discharge
25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes
26 Protection of the active implantable medical device from damage caused by temperature changes <\/td>\n<\/tr>\n
24<\/td>\n27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation
27.101 Immunity
27.102 General test conditions <\/td>\n<\/tr>\n
26<\/td>\n27.103 Protection from static magnetic fields <\/td>\n<\/tr>\n
27<\/td>\n27.104 Protection from magnetic fields in the range 10 Hz to 30 MHz <\/td>\n<\/tr>\n
29<\/td>\n27.105 Protection from electromagnetic fields in the range 30 MHz to 450 MHz <\/td>\n<\/tr>\n
30<\/td>\n27.106 Protection from electromagnetic fields in the range 450 MHz to 3 GHz <\/td>\n<\/tr>\n
31<\/td>\n28 Accompanying documentation <\/td>\n<\/tr>\n
33<\/td>\nAnnex AA Relationship between the fundamental principles in ISO\/TR 14283 [8] and the clauses of this part of ISO 14708 <\/td>\n<\/tr>\n
45<\/td>\nAnnex BB Relationship between the clauses of this part of ISO 14708 and the fundamental principles listed in Annex AA <\/td>\n<\/tr>\n
47<\/td>\nAnnex CC Rationale
CC.1 General
CC.2 Notes on specific clauses and subclauses <\/td>\n<\/tr>\n
57<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 14708-4:2008\/(R)2011 – Implants for surgery-Active implantable medical devices-Part 4: Implantable infusion pumps<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2008<\/td>\n58<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198199,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198197","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","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\/198197","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\/198199"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198197"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198197"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198197"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}