{"id":198245,"date":"2024-10-19T12:37:13","date_gmt":"2024-10-19T12:37:13","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-80369-7-2016\/"},"modified":"2024-10-25T05:10:21","modified_gmt":"2024-10-25T05:10:21","slug":"aami-80369-7-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-80369-7-2016\/","title":{"rendered":"AAMI 80369 7 2016"},"content":{"rendered":"

Specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connectors in intravascular applicationsS or hypodermic connections in hypodermic applications of medical devices and accessories.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 80369-7:2016;2016Small-bore connectors for liquids and gases in healthcare applications\u2014Part 7: Connectors for intravascular or hypodermic applications <\/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 <\/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 of AAMI\/ISO 80369-7:2016 <\/td>\n<\/tr>\n
10<\/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 General requirements
4.1 General requirements for luer connectors <\/td>\n<\/tr>\n
16<\/td>\n4.2 Material used for luer connectors
4.3 Type tests
5 * Dimensional requirements for luer connectors
6 Performance requirements
6.1 Fluid leakage
6.1.1 Fluid leakage requirement
6.1.2 Leakage by pressure decay <\/td>\n<\/tr>\n
17<\/td>\n6.1.3 Positive pressure liquid leakage
6.2 Sub-atmospheric pressure air leakage
6.3 Stress cracking
6.4 Resistance to separation from axial load
6.5 Resistance to separation from unscrewing
6.6 Resistance to overriding <\/td>\n<\/tr>\n
18<\/td>\nAnnex A (informative) Rationale and guidance
A.1 General guidance
A.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
20<\/td>\nFigure A.1\u2014Lug corners that can interfere
Figure A.2\u2014Area of potential interference <\/td>\n<\/tr>\n
22<\/td>\nAnnex B (normative) luer connectors
Figure B.1\u2014Male luer slip connector (L1)
Table B.1\u2014Male luer slip connector dimensions (L1) <\/td>\n<\/tr>\n
23<\/td>\nFigure B.2\u2014Female luer slip connector (L1)
Table B.2\u2014Female luer slip connector dimensions (L1) <\/td>\n<\/tr>\n
24<\/td>\nFigure B.3\u2014Male luer lock connector (L2), with fixed collar <\/td>\n<\/tr>\n
25<\/td>\nTable B.3\u2014Male luer lock connector with fixed collar dimensions (L2) <\/td>\n<\/tr>\n
26<\/td>\nFigure B.4\u2014Male luer lock connector (L2), with rotatable collar
Table B.4\u2014Male luer lock connector with a rotatable collar dimensions (L2) <\/td>\n<\/tr>\n
27<\/td>\nFigure B.5\u2014Female luer lock connector (L2) <\/td>\n<\/tr>\n
28<\/td>\nTable B.5\u2014Female luer lock connector dimensions (L2) <\/td>\n<\/tr>\n
29<\/td>\nFigure B.6\u2014Female luer lock connector with lugs at right angle to axis (L2), variant A <\/td>\n<\/tr>\n
30<\/td>\n*Table B.6\u2014Female luer lock connector dimensions (L2), variant A <\/td>\n<\/tr>\n
31<\/td>\nFigure B.7\u2014Female luer lock connector with lugs at right angle to axis (L2), variant B <\/td>\n<\/tr>\n
32<\/td>\nTable B.7\u2014Female luer lock connector dimensions (L2), variant B
Figure B.8\u2014Female luer lock connector with lugs at right angle to axis (L2), variant C <\/td>\n<\/tr>\n
33<\/td>\nTable B.8\u2014Female luer lock connector dimensions (L2), variant C <\/td>\n<\/tr>\n
34<\/td>\nAnnex C (normative) Reference connectors
C.1 General requirements for reference connectors
C.2 Reference connectors <\/td>\n<\/tr>\n
35<\/td>\nFigure C.1\u2014Female reference luer lock connector for testing male luer connectors for leakage, separation from unscrewing, stress cracking and non-interconnectable characteristics <\/td>\n<\/tr>\n
36<\/td>\nFigure C.2\u2014Male reference luer slip connector for testing female luer connectors for leakage, separation from axial load, stress cracking and non-interconnectable characteristics <\/td>\n<\/tr>\n
37<\/td>\nFigure C.3\u2014Female reference connector for testing male luer lock connector for separation from axial load and resistance to overriding <\/td>\n<\/tr>\n
38<\/td>\nFigure C.4\u2014Male reference luer lock connector for testing female luer connectors for leakage, separation from unscrewing, stress cracking and non-interconnectable characteristics <\/td>\n<\/tr>\n
39<\/td>\nFigure C.5\u2014Female reference luer slip connector for testing male luer connectors for leakage, separation from axial load, stress cracking and non-interconnectable characteristics <\/td>\n<\/tr>\n
40<\/td>\nFigure C.6\u2014Male reference connector for testing female luer lock connector for separation from axial load and resistance to overriding <\/td>\n<\/tr>\n
41<\/td>\nAnnex D (informative) Assessment of medical devices and their attributes with connections within this application <\/td>\n<\/tr>\n
42<\/td>\nTable D.1\u2014Examples of medical devices with connections within this application and their attributes <\/td>\n<\/tr>\n
43<\/td>\nAnnex E (informative) Summary of the usability requirements for luer connectors for intravascular or hypodermic applications
E.1 user profile
Table E.1\u2014User profile
E.2 Use scenarios <\/td>\n<\/tr>\n
44<\/td>\nTable E.2\u2014Use scenarios <\/td>\n<\/tr>\n
45<\/td>\nE.3 Use environments
E.3.1 Facilities
E.3.2 Use temperature
E.4 Other attributes
E.5 Generic user needs <\/td>\n<\/tr>\n
48<\/td>\nAnnex F (informative) Summary of luer connector design requirements for intravascular or hypodermic applications
Table F.1\u2014Luer connector specific design requirements for intravascular or hypodermic applications <\/td>\n<\/tr>\n
51<\/td>\nAnnex G (informative) Summary of assessment of the design of the luer connector for intravascular or hypodermic 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 \u200bluer connector male to N1 male <\/td>\n<\/tr>\n
52<\/td>\nFigure G.1\u2014Illustration luer connector male to N1 male misconnection
G.2.3 luer slip connector female to E1 female
G.2.4 luer slip connector female to N2 male lock
G.3 Summary of the design verification <\/td>\n<\/tr>\n
53<\/td>\nG.4 Summary of the design validation
G.5 Summary of the design review <\/td>\n<\/tr>\n
54<\/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
55<\/td>\nAnnex I (informative) Terminology\u2014Alphabetized index of defined terms <\/td>\n<\/tr>\n
57<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 80369-7:2016 – Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic 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>\n58<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198250,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198245","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\/198245","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\/198250"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198245"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198245"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198245"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}