{"id":197946,"date":"2024-10-19T12:36:10","date_gmt":"2024-10-19T12:36:10","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-15674-2016\/"},"modified":"2024-10-25T05:09:28","modified_gmt":"2024-10-25T05:09:28","slug":"aami-15674-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-15674-2016\/","title":{"rendered":"AAMI 15674 2016"},"content":{"rendered":"

Specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy\/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery.<\/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 15674:2016; Cardiovascular implants and artificial organs\u2014Hard-shell cardiotomy\/venous reservoir systems (with\/without filter) and soft venous reservoir bags <\/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 15674:2016 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Normative references
3 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 <\/td>\n<\/tr>\n
14<\/td>\n4.2 Physical characteristics
4.2.1 General
4.2.2 Blood volumes
4.2.3 Connectors
4.3 Performance characteristics
4.3.1 Blood cell damage
4.3.1.1 Plasma-free haemoglobin
4.3.1.2 Platelet reduction and white blood cell reduction
4.3.2 Air-handling capacity
4.3.3 Priming volume of the reservoirs in accordance with the manufacturer\u2019s quality control management system
4.3.4 Defoaming characteristics <\/td>\n<\/tr>\n
15<\/td>\n4.3.5 Volume calibration
4.3.6 Filtration efficiency
4.3.7 Break-through volume
4.3.8 Dynamic priming volume
4.3.9 Minimum and maximum volumes
4.3.10 Shelf life
5 Tests and measurements to determine compliance with this document
5.1 General
5.2 Biological characteristics
5.2.1 Sterility and non-pyrogenicity <\/td>\n<\/tr>\n
16<\/td>\n5.2.2 Biocompatibility
5.3 Physical characteristics
5.3.1 Blood pathway integrity for soft venous reservoir bags
5.3.2 Blood pathway integrity for sealed hard-shell reservoirs
5.3.3 Connectors
5.3.4 Blood cell damage
5.3.4.1 Test media
5.3.4.2 Procedure
Table 1 \u2014 Conditions for in vitro testing of blood cell damage <\/td>\n<\/tr>\n
17<\/td>\nTable 2 \u2014 Sampling schedule
5.3.5 Filtration efficiency
5.3.5.1 Test liquid
5.3.5.2 Procedure
5.3.6 Shelf life
6 Information supplied by the manufacturer
6.1 Information on the reservoir (labelling) <\/td>\n<\/tr>\n
18<\/td>\n6.2 Information on the packaging
6.2.1 Information on the unit container
6.2.2 Information on the shipping container
6.3 Information in the accompanying documents <\/td>\n<\/tr>\n
19<\/td>\n6.4 Information in the accompanying documents in a prominent form
7 Packaging <\/td>\n<\/tr>\n
20<\/td>\nAnnex A (normative) Factors to be considered in evaluating performance characteristics <\/td>\n<\/tr>\n
21<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 15674:2016 – Cardiovascular implants and artificial organs – Hard-shell cardiotomy\/venous reservoir systems (with\/without filter) and soft venous reservoir bags<\/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>\n21<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":197951,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-197946","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\/197946","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\/197951"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=197946"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=197946"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=197946"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}