{"id":198015,"date":"2024-10-19T12:36:24","date_gmt":"2024-10-19T12:36:24","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-80369-1-2018\/"},"modified":"2024-10-25T05:09:39","modified_gmt":"2024-10-25T05:09:39","slug":"aami-80369-1-2018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-80369-1-2018\/","title":{"rendered":"AAMI 80369 1 2018"},"content":{"rendered":"

Specifies general requirements for SMALL-BORE CONNECTORS, which convey liquids or gases in healthcare APPLICATIONS. These SMALL-BORE CONNECTORS are used in MEDICAL DEVICES or ACCESSORIES intended for use with a PATIENT.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 80369-1:2018; Small-bore connectors for liquids and gases in healthcare applications\u2014Part 1: General requirements <\/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>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of ANSI\/AAMI adoption of ISO 80369-1:2018 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 *Scope <\/td>\n<\/tr>\n
14<\/td>\n2 *Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 *Materials
5 Small-bore connector incompatibility <\/td>\n<\/tr>\n
17<\/td>\n6 *Clinical applications
6.1 *Additional small-bore connector designs
6.2 Enteral applications
6.3 Limb cuff inflation applications
6.4 Neuraxial applications
6.5 Intravascular or hypodermic applications <\/td>\n<\/tr>\n
18<\/td>\n7 *Alternative small-bore connectors <\/td>\n<\/tr>\n
19<\/td>\nAnnex A (informative) Rationale <\/td>\n<\/tr>\n
22<\/td>\nAnnex B (normative) Test methods for demonstrating non-interconnectable characteristics
B.1 Principle
B.2 Dimensional analysis test method
B.2.1 General
B.2.2 Requirements
B.2.3 Identification of potential contactable surface diameters and features <\/td>\n<\/tr>\n
23<\/td>\nFigure B.1\u2014Example of typical fixed collar male connector diameters to be evaluated
Figure B.2\u2014Example of typical full threaded female connector diameters to be evaluated <\/td>\n<\/tr>\n
24<\/td>\nFigure B.3\u2014Example of a typical rib diameter to be evaluated
Figure B.4\u2014Example of a typical connector with a lug to be evaluated <\/td>\n<\/tr>\n
25<\/td>\nFigure B.5\u2014Example of a typical cylinder-to-cylinder interface to be evaluated
Figure B.6\u2014Example of a typical cylinder to full thread interface to be evaluated <\/td>\n<\/tr>\n
26<\/td>\nFigure B.7\u2014Example of a typical cylinder to full thread interface to be evaluated (cross-section view)
Figure B.8\u2014Example of a typical cylinder to external lug interface to be evaluated
Figure B.9\u2014Example of a typical cylinder to external lug interface to be evaluated (cross-section view) <\/td>\n<\/tr>\n
27<\/td>\nFigure B.10\u2014Example of a typical thread-to-thread interface to be evaluated (cross-section view)
B.2.4 Identification of the insertion and interaction potential of contactable surfaces <\/td>\n<\/tr>\n
28<\/td>\nFigure B.11\u2014Example of a feature or geometry inhibiting a misconnection
B.2.5 Calculation of clearances (gaps), overlaps and interferences
B.2.6 Analysis of the mathematical results of clearances (gaps), overlaps and interferences <\/td>\n<\/tr>\n
29<\/td>\nTable B.1\u2014Dimensional analysis from the equation results
Table B.2 \u2014Misconnection interference limits <\/td>\n<\/tr>\n
30<\/td>\nB.3 Physical test methods
B.3.1 General
B.3.2 *Requirements
B.3.3 Small-bore connector under evaluation
B.3.4 Target interference connector or feature <\/td>\n<\/tr>\n
31<\/td>\nB.3.5 Mechanical test method
B.3.5.1 Apparatus
B.3.5.2 Test sample preconditioning
B.3.5.3 Procedure <\/td>\n<\/tr>\n
32<\/td>\nB.3.6 Leak test method
B.3.6.1 Apparatus
B.3.6.2 Test sample preconditioning
B.3.6.3 Procedure <\/td>\n<\/tr>\n
34<\/td>\nFigure B.12\u2014Leak TEST METHOD set up <\/td>\n<\/tr>\n
35<\/td>\nAnnex C (informative) Symbols and safety signs
Table C.1\u2014Safety sign <\/td>\n<\/tr>\n
36<\/td>\nAnnex D (normative) Assessment procedures small-bore connectors
D.1 General
D.1.1 Request to include a new design
D.1.2 Intellectual Property Rights
D.2 * Design proposal
D.3 Engineering analysis
D.3.1 Design <\/td>\n<\/tr>\n
37<\/td>\nD.3.2 Design realization
D.3.3 Design verification
D.3.4 Design validation
D.4 Design review <\/td>\n<\/tr>\n
38<\/td>\nAnnex E (informative) Applications of small-bore connectors
Table E.1\u2014Applications of small-bore connectors <\/td>\n<\/tr>\n
40<\/td>\nAnnex F (informative) Reference to the Essential Principles
Table F.1\u2014Correspondence between this document and the essential principles <\/td>\n<\/tr>\n
41<\/td>\nBibliography <\/td>\n<\/tr>\n
43<\/td>\nAlphabetized index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 80369-1:2018 – Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements.<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2018<\/td>\n43<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198017,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198015","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\/198015","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\/198017"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198015"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198015"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}