{"id":198391,"date":"2024-10-19T12:37:46","date_gmt":"2024-10-19T12:37:46","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-80369-6-2016\/"},"modified":"2024-10-25T05:10:48","modified_gmt":"2024-10-25T05:10:48","slug":"aami-80369-6-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-80369-6-2016\/","title":{"rendered":"AAMI 80369 6 2016"},"content":{"rendered":"

Specifies requirements for SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in neuraxial APPLICATIONS. Neuraxial APPLICATIONS involve the use of MEDICAL DEVICES intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.<\/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\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 80369-6:2016, Small-bore connectors for liquids and gases in healthcare applications\u2014 Part 6: Connectors for neuraxial applications <\/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>\nCopyright 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 ANSI\/AAMI\/ISO 80369-6:2016 <\/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 neuraxial application <\/td>\n<\/tr>\n
16<\/td>\n4.2 * Material used for small-bore connectors
4.3 Type tests
5 Dimensional requirements for neuraxial 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 Subatmospheric pressure air leakage <\/td>\n<\/tr>\n
17<\/td>\n6.3 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: Rationale and guidance
A.1 General guidance
A.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
22<\/td>\nAnnex B: * Small-bore connectors for neuraxial applications
Figure B.1 \u2014 Male neuraxial slip connector (N1)
Table B.1 \u2014 Male neuraxial SLIP CONNECTOR dimensions (N1) <\/td>\n<\/tr>\n
24<\/td>\nFigure B.2 \u2014 Male neuraxial lock connector (N2) <\/td>\n<\/tr>\n
25<\/td>\nTable B.2 \u2014 Male neuraxial lock connector dimensions (N2) <\/td>\n<\/tr>\n
26<\/td>\nFigure B.3 \u2014 Male neuraxial lock connector with rotatable collar (N2) <\/td>\n<\/tr>\n
27<\/td>\nTable B.3 \u2014 Male neuraxial lock connector with rotatable collar dimensions (N2)
Figure B.4 \u2014 Female neuraxial LOCK CONNECTOR (N2) <\/td>\n<\/tr>\n
28<\/td>\nTable B.4 \u2014 Female neuraxial lock connector dimensions (N2) <\/td>\n<\/tr>\n
29<\/td>\nFigure B.5 \u2014 Female neuraxial lock connector with lugs (N2)
Table B.5 \u2014 Female neuraxial lock connector with lugs dimensions (N2) <\/td>\n<\/tr>\n
31<\/td>\nAnnex C: Reference connectors for testing small-bore connectors for neuraxial applications
C.1 General requirements for reference connectors <\/td>\n<\/tr>\n
32<\/td>\nC.2 Reference connectors
Figure C.1 \u2014 Female reference LOCK CONNECTOR for testing male neuraxial CONNECTORS for leakage, separation from unscrewing, stress cracking and NON-INTERCONNECTABLE characteristics <\/td>\n<\/tr>\n
33<\/td>\nFigure C.2 \u2014 Male reference SLIP CONNECTOR for testing female neuraxial CONNECTORS for leakage, stress cracking and NON-INTERCONNECTABLE characteristics <\/td>\n<\/tr>\n
34<\/td>\nFigure C.3 \u2014 Female reference CONNECTOR for testing male neuraxial CONNECTORS for separation from axial load and resistance to overriding <\/td>\n<\/tr>\n
35<\/td>\nFigure C.4 \u2014 Male reference LOCK CONNECTOR for testing female neuraxial CONNECTORS for leakage, separation from unscrewing, stress cracking and NON-INTERCONNECTABLE characteristics <\/td>\n<\/tr>\n
36<\/td>\nFigure C.5 \u2014 Male reference connector for testing female neuraxial lock connectors from axial load and resistance to overriding <\/td>\n<\/tr>\n
38<\/td>\nAnnex D: Assessment of medical devices and their attributes with connections within this application <\/td>\n<\/tr>\n
39<\/td>\nTable D.1 \u2014 Examples of medical devices with connections within this application and their attributes <\/td>\n<\/tr>\n
40<\/td>\nAnnex E: Summary of the usability requirements for small-bore connectors for neuraxial applications
E.1 User profile
Table E.1 \u2014 USER PROFILE
E.2 Use scenarios <\/td>\n<\/tr>\n
41<\/td>\nTable E.2 \u2014 Use scenarios
E.3 Use environments
E.3.1 Facilities
E.3.2 Use temperatures
E.4 Other attributes <\/td>\n<\/tr>\n
42<\/td>\nE.5 Generic user needs <\/td>\n<\/tr>\n
43<\/td>\nAnnex F: Summary of small-bore connector design requirements for neuraxial applications
Table F.1 \u2014 Neuraxial connector \u2014 specific design requirements <\/td>\n<\/tr>\n
47<\/td>\nAnnex G: Summary of assessment of the design of the small bore connectors for neuraxial applications
G.1 General
G.2 Summary of the engineering analysis of the design
G.2.1 Non-interconnectable analysis
Table G.1 \u2014 Summary of possible misconnection from CAD analysis <\/td>\n<\/tr>\n
48<\/td>\nG.2.2 N1 male to E1 male
G.2.3 N1 male to S1 male
G.2.4 N1 male to luer connector male
Figure G.1 \u2014 Illustration of N1 male to LUER CONNECTOR male misconnection
G.2.5 N2 male to luer slip connector female
G.2.6 N2 female to E1 female <\/td>\n<\/tr>\n
49<\/td>\nG.3 Summary of the design verification
G.4 Summary of the design validation <\/td>\n<\/tr>\n
50<\/td>\nG.4.1 Usability misconnection evaluation
G.5 Summary of the design review <\/td>\n<\/tr>\n
51<\/td>\nAnnex H: Mechanical tests for verifying non-interconnectable characteristics
H.1 * Purpose
H.2 Requirement
H.3 Test method
H.4 Test procedure, physical force
H.4.1 Apparatus
H.4.2 Procedure <\/td>\n<\/tr>\n
52<\/td>\nH.5 * Test procedure, connector incompatibility (gross leakage)
H.5.1 Apparatus
H.5.2 Procedure <\/td>\n<\/tr>\n
54<\/td>\nAnnex I: Reference to the essential principles
Table I.1 \u2014 Correspondence between this document and the essential principles <\/td>\n<\/tr>\n
56<\/td>\nAnnex J: Terminology \u2014 alphabetized index of defined terms <\/td>\n<\/tr>\n
58<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 80369-6:2016 – Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial 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>\n59<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198397,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198391","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\/198391","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\/198397"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198391"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198391"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198391"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}