{"id":198021,"date":"2024-10-19T12:36:26","date_gmt":"2024-10-19T12:36:26","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-15676-2016\/"},"modified":"2024-10-25T05:09:40","modified_gmt":"2024-10-25T05:09:40","slug":"aami-15676-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-15676-2016\/","title":{"rendered":"AAMI 15676 2016"},"content":{"rendered":"

Specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). Applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and\/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. <6 h duration) CPB surgery or (long-term, i.e. >24 h) ECMO procedures. Sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as \u201csterile\u201d.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 15676:2016; Cardiovascular implants and artificial organs\u2014Requirements for single-use tubing packs for
\ncardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards andrecommended 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 Page <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of AAMI adoption of ISO 15676:2016 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
12<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
13<\/td>\n4 Requirements
4.1 Biological characteristics
4.1.1 Sterility and non-pyrogenicity
4.1.2 Biocompatibility
4.2 Physical characteristics
4.2.1 General
4.2.2 Dimensions
4.2.3 Material properties <\/td>\n<\/tr>\n
14<\/td>\n4.3 Performance characteristics
4.3.1 Priming volume
4.3.2 Life to failure testing
4.3.3 Spallation
4.3.4 Shelf life
5 Tests and measurements
5.1 General
5.2 Biological characteristics
5.2.1 Sterility and non-pyrogenicity <\/td>\n<\/tr>\n
15<\/td>\n5.2.2 Biocompatibility
5.3 Physical characteristics
5.3.1 Blood pathway integrity
5.3.2 Connections
5.3.3 Tubing material property testing
5.4 Performance characteristics
5.4.1 Tubing life
5.4.2 Spallation in tubing used in roller pumps <\/td>\n<\/tr>\n
16<\/td>\n5.4.3 Shelf life
6 Information supplied by the manufacturer
6.1 Information on the tubing pack
6.1.1 Information on the unit container
6.1.2 Information on the shipping container <\/td>\n<\/tr>\n
17<\/td>\n6.2 Information on the accompanying documents
6.3 Information in the accompanying documents in a prominent form
6.4 Information to be provided by manufacturer upon request <\/td>\n<\/tr>\n
18<\/td>\n7 Packaging <\/td>\n<\/tr>\n
19<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 15676:2016 – Cardiovascular implants and artificial organs-Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2016<\/td>\n19<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198023,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198021","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\/198021","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\/198023"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198021"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198021"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198021"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}