{"id":198396,"date":"2024-10-19T12:37:46","date_gmt":"2024-10-19T12:37:46","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-80369-5-2016\/"},"modified":"2024-10-25T05:10:50","modified_gmt":"2024-10-25T05:10:50","slug":"aami-80369-5-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-80369-5-2016\/","title":{"rendered":"AAMI 80369 5 2016"},"content":{"rendered":"

Specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in limb cuff inflation applications of medical devices and accessories. Limb cuff inflation applications include connections between a sphygmomanometer and its cuff.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 80369-5:2016, Small-bore connectors for liquids and gases in healthcare applications\u2014Part 5: Connectors for limb cuff inflation applications <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and
\nrecommended 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 80369-5:2016 <\/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 the limb cuff inflation application <\/td>\n<\/tr>\n
16<\/td>\n4.2 Materials used for small-bore connectors
4.3 Type tests
5 Dimensional requirements for sphygmomanometer and cuff small-bore connectors
5.1 * Requirements for adult or paediatric patient small-bore connectors (S1)
5.2 Void
6 Performance requirements
6.1 Air leakage
6.2 * Resistance to separation from axial load <\/td>\n<\/tr>\n
17<\/td>\nAnnex A (informative) Rationale and guidance
A.1 General guidance
A.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
19<\/td>\nAnnex B (normative) Small-bore connectors for the limb cuff inflation application
Figure B.1 \u2013 Male cuff S1 SMALL-BORE CONNECTOR <\/td>\n<\/tr>\n
20<\/td>\nTable B.1 \u2013 Male cuff S1 SMALL-BORE CONNECTOR dimensions <\/td>\n<\/tr>\n
21<\/td>\nFigure B.2 \u2013 Female sphygmomanometer S1 SMALL-BORE CONNECTOR
Figure B.3 \u2013 Sphygmomanometer and cuff SMALL-BORE CONNECTOR (S1) assembly <\/td>\n<\/tr>\n
22<\/td>\nTable B.2 \u2013 Female sphygmomanometer S1 SMALL-BORE CONNECTOR dimensions <\/td>\n<\/tr>\n
23<\/td>\nAnnex C (normative) Reference connectors
C.1 General requirements for reference connectors
C.2 * Sphygmomanometer and cuff S1 reference connectors <\/td>\n<\/tr>\n
24<\/td>\nAnnex D (informative) Assessment of medical devices and their attributes with connections within this application <\/td>\n<\/tr>\n
25<\/td>\nAnnex E (informative) Summary of the usability requirements for small-bore connectors for limb cuff inflation applications
E.1 User profile
Table E.1 \u2013 USER PROFILE <\/td>\n<\/tr>\n
26<\/td>\nE.2 Use scenarios
E.3 Use environments and scenarios
E.4 Generic user needs <\/td>\n<\/tr>\n
27<\/td>\nAnnex F (informative) Summary of small-bore connector design requirements for limb cuff inflation applications
Table F.1 \u2013 Adult or paediatric PATIENT sphygmomanometerand cuff S1 CONNECTOR-specific design requirements <\/td>\n<\/tr>\n
31<\/td>\nTable F.2 \u2013 Neonatal sphygmomanometer and cuff CONNECTOR-specificdesign requirements <\/td>\n<\/tr>\n
35<\/td>\nAnnex G (informative) Summary of assessment of the design of the connectors for limb cuff inflation application
G.1 General
G.2 Summary of the engineering analysis of the design
G.2.1 Non-interconnectable analysis
Table G.1 \u2013 Summary of possible misconnection from CAD analysis
G.2.2 S1 male to N1 male
G.3 Summary of the design verification <\/td>\n<\/tr>\n
36<\/td>\nG.4 Summary of the design validation
G.5 Summary of the design review <\/td>\n<\/tr>\n
37<\/td>\nAnnex H (informative) Obsolete limb cuff inflation connector <\/td>\n<\/tr>\n
38<\/td>\nFigure H.1 \u2013 Obsolete sphygmomanometer and cuff SMALL-BORE CONNECTOR <\/td>\n<\/tr>\n
39<\/td>\nTable H.1 \u2013 Obsolete male sphygmomanometerand cuff SMALL-BORE CONNECTOR dimensions
Table H.2 \u2013 Obsolete female sphygmomanometerand cuff SMALL-BORE CONNECTOR dimensions <\/td>\n<\/tr>\n
40<\/td>\nAnnex I (informative) Air leakage by pressure decay test method
I.1 Principle
I.2 * Test conditions
I.2.1 Test sample preconditioning
I.2.2 Environmental test conditions
I.3 Apparatus
I.4 Procedure <\/td>\n<\/tr>\n
41<\/td>\nI.5 Test report <\/td>\n<\/tr>\n
43<\/td>\nAnnex J (informative) Resistance to separation from axial load test method
J.1 Principle
J.2 * Test conditions
J.2.1 Test sample preconditioning
J.2.2 Environmental test conditions
J.3 Apparatus
J.4 Procedure
J.5 Test report <\/td>\n<\/tr>\n
44<\/td>\nAnnex K (informative) Reference to the essential principles
Table K.1 \u2013 Correspondence between this documentand the essential principles <\/td>\n<\/tr>\n
46<\/td>\nIndex of defined terms <\/td>\n<\/tr>\n
47<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 80369-5:2016 – Small-bore connectors for liquids and gases in healthcare applications – Part 5: Connectors for limb cuff inflation 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>\n47<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198400,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198396","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\/198396","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\/198400"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198396"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198396"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198396"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}