{"id":198246,"date":"2024-10-19T12:37:13","date_gmt":"2024-10-19T12:37:13","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-80369-3-2016\/"},"modified":"2024-10-25T05:10:21","modified_gmt":"2024-10-25T05:10:21","slug":"aami-80369-3-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-80369-3-2016\/","title":{"rendered":"AAMI 80369 3 2016"},"content":{"rendered":"

Specifies the dimensions and requirements for the design and functional performance of SMALLBORE CONNECTORS intended to be used for CONNECTIONS on ENTERAL MEDICAL DEVICES and ACCESSORIES.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 80369-3:2016; Small-bore connectors for liquids and gases in healthcare applications\u2014Part 3: Connectors for enteral applications <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground on ANSI\/AAMI adoption of ISO 80369-3:2016 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/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 General requirements
4.1 General requirements for the enteral application
4.2 Material used for enteral small-bore connectors <\/td>\n<\/tr>\n
16<\/td>\n4.3 Type tests
5 Dimensional requirements for enteral small-bore connectors
6 Performance requirements
6.1 Fluid leakage
6.1.1 Fluid leakage requirement
6.1.2 Leakage by pressure decay
6.1.3 Positive pressure liquid leakage
6.2 Stress cracking
6.3 Resistance to separation from axial load <\/td>\n<\/tr>\n
17<\/td>\n6.4 Resistance to separation from unscrewing
6.5 Resistance to overriding
6.6 Disconnection by unscrewing <\/td>\n<\/tr>\n
18<\/td>\nAnnex A (informative) Rationale and guidance
A.1 General guidance
A.1.1 Guidance
A.1.2 Connector selection
A.1.3 Colour coding
A.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
22<\/td>\nAnnex B (normative) Enteral small-bore connectors
Figure B.1\u2014Male E1 small-bore connector <\/td>\n<\/tr>\n
23<\/td>\nTable B.1\u2014Male E1 small-bore connector dimensions <\/td>\n<\/tr>\n
24<\/td>\nFigure B.2\u2014Female E1 small-bore connector <\/td>\n<\/tr>\n
26<\/td>\nFigure B.3\u2014E1 connector assembly <\/td>\n<\/tr>\n
27<\/td>\nAnnex C (normative) Reference connectors
C.1 General requirements for reference connectors
C.2 Reference connectors <\/td>\n<\/tr>\n
28<\/td>\nFigure C.1\u2014Female reference CONNECTOR for testing male ENTERAL CONNECTOR for leakage, disconnection byunscrewing, separation from unscrewing, stress cracking, and NON-INTERCONNECTABLE characteristics <\/td>\n<\/tr>\n
29<\/td>\nFigure C.2\u2014Female reference connector for testing male enteral connector for separation from axial load, resistance to overriding, and non-interconnectable characteristics <\/td>\n<\/tr>\n
30<\/td>\nFigure C.3\u2014Male reference connector for testing female enteral connector for leakage, disconnection by unscrewing, separation from unscrewing, stress cracking, and non-interconnectable characteristics <\/td>\n<\/tr>\n
31<\/td>\nFigure C.4\u2014Male reference CONNECTOR for testing female ENTERAL CONNECTOR for separation from axial load,resistance to overriding, and NON-INTERCONNECTABLE characteristics <\/td>\n<\/tr>\n
32<\/td>\nAnnex D (informative) Assessment of medical devices and their attributes with connections within this application
Table D.1\u2014Examples of medical devices with connections within this application and their attributes <\/td>\n<\/tr>\n
33<\/td>\nAnnex E (informative) Summary of the usability requirements for small-bore connectors for enteral applications
E.1 User profile
Table E.1\u2014User profile
E.2 Use scenarios <\/td>\n<\/tr>\n
34<\/td>\nTable E.2\u2014Use scenarios, enteral feeding
Table E.3\u2014Use scenarios, medication delivery <\/td>\n<\/tr>\n
35<\/td>\nTable E.4\u2014Use scenarios, decompression, and suction of GI content
Table E.5\u2014Use scenarios, delivery of radiologic contrast material
E.3 Use environments
E.3.1 Facilities
E.3.2 Use temperature <\/td>\n<\/tr>\n
36<\/td>\nE.4 Other attributes
E.5 Generic user needs <\/td>\n<\/tr>\n
38<\/td>\nAnnex F (informative) Summary of small-bore connector criteria and requirements for enteral applications
Table F.1\u2014Enteral connector-specific design criteria and requirements <\/td>\n<\/tr>\n
41<\/td>\nAnnex G (informative) Summary of assessment of the design of the connectors for enteral applications
G.1 General
G.2 Summary of the engineering analysis of the design
G.2.1 Non-interconnectable analysis
Table G.1\u2014Summary of possible misconnection from CAD analysis
G.2.2 E1 male to N1 male
G.2.3 E1 female to luer slip connector female <\/td>\n<\/tr>\n
42<\/td>\nG.2.4 E1 female to N1 female
G.3 Summary of the design verification <\/td>\n<\/tr>\n
43<\/td>\nG.4 Summary of the design validation
G.4.1 General
G.4.2 Test procedure
G.4.3 Test participants <\/td>\n<\/tr>\n
44<\/td>\nG.4.4 Test results <\/td>\n<\/tr>\n
45<\/td>\nTable G.2\u2014Summary of findings for the failed participant
G.4.5 Summative validation study conclusions
G.5 Summary of the design review <\/td>\n<\/tr>\n
47<\/td>\nAnnex H (informative) Reference to the essential principles
Table H.1\u2014Correspondence between this part of ISO 80369 and the essential principles <\/td>\n<\/tr>\n
49<\/td>\nAnnex I (informative) Terminology\u2014Alphabetized index of defined terms <\/td>\n<\/tr>\n
50<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 80369-3:2016 – Small-bore connectors for liquids and gases in healthcare applications-Part 3: Connectors for enteral applications.<\/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>\n50<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198251,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198246","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\/198246","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\/198251"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198246"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198246"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198246"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}