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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.

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PDF Pages	PDF Title
1	ANSI/AAMI/ISO 80369-7:2016;2016Small-bore connectors for liquids and gases in healthcare applications—Part 7: Connectors for intravascular or hypodermic applications
2	Objectives and uses of AAMI standards andrecommended practices
3	Title page
4	AAMI Standard Copyright information
5	Contents
6	Glossary of equivalent standards
7	Committee representation
9	Background of AAMI/ISO 80369-7:2016
10	Foreword
12	Introduction
13	1 * Scope 2 Normative references
14	3 Terms and definitions
15	4 General requirements 4.1 General requirements for luer connectors
16	4.2 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
17	6.1.3 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
18	Annex A (informative) Rationale and guidance A.1 General guidance A.2 Rationale for particular clauses and subclauses
20	Figure A.1—Lug corners that can interfere Figure A.2—Area of potential interference
22	Annex B (normative) luer connectors Figure B.1—Male luer slip connector (L1) Table B.1—Male luer slip connector dimensions (L1)
23	Figure B.2—Female luer slip connector (L1) Table B.2—Female luer slip connector dimensions (L1)
24	Figure B.3—Male luer lock connector (L2), with fixed collar
25	Table B.3—Male luer lock connector with fixed collar dimensions (L2)
26	Figure B.4—Male luer lock connector (L2), with rotatable collar Table B.4—Male luer lock connector with a rotatable collar dimensions (L2)
27	Figure B.5—Female luer lock connector (L2)
28	Table B.5—Female luer lock connector dimensions (L2)
29	Figure B.6—Female luer lock connector with lugs at right angle to axis (L2), variant A
30	*Table B.6—Female luer lock connector dimensions (L2), variant A
31	Figure B.7—Female luer lock connector with lugs at right angle to axis (L2), variant B
32	Table B.7—Female luer lock connector dimensions (L2), variant B Figure B.8—Female luer lock connector with lugs at right angle to axis (L2), variant C
33	Table B.8—Female luer lock connector dimensions (L2), variant C
34	Annex C (normative) Reference connectors C.1 General requirements for reference connectors C.2 Reference connectors
35	Figure C.1—Female reference luer lock connector for testing male luer connectors for leakage, separation from unscrewing, stress cracking and non-interconnectable characteristics
36	Figure C.2—Male reference luer slip connector for testing female luer connectors for leakage, separation from axial load, stress cracking and non-interconnectable characteristics
37	Figure C.3—Female reference connector for testing male luer lock connector for separation from axial load and resistance to overriding
38	Figure C.4—Male reference luer lock connector for testing female luer connectors for leakage, separation from unscrewing, stress cracking and non-interconnectable characteristics
39	Figure C.5—Female reference luer slip connector for testing male luer connectors for leakage, separation from axial load, stress cracking and non-interconnectable characteristics
40	Figure C.6—Male reference connector for testing female luer lock connector for separation from axial load and resistance to overriding
41	Annex D (informative) Assessment of medical devices and their attributes with connections within this application
42	Table D.1—Examples of medical devices with connections within this application and their attributes
43	Annex E (informative) Summary of the usability requirements for luer connectors for intravascular or hypodermic applications E.1 user profile Table E.1—User profile E.2 Use scenarios
44	Table E.2—Use scenarios
45	E.3 Use environments E.3.1 Facilities E.3.2 Use temperature E.4 Other attributes E.5 Generic user needs
48	Annex F (informative) Summary of luer connector design requirements for intravascular or hypodermic applications Table F.1—Luer connector specific design requirements for intravascular or hypodermic applications
51	Annex 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—Summary of possible misconnection from CAD analysis G.2.2 luer connector male to N1 male
52	Figure G.1—Illustration 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
53	G.4 Summary of the design validation G.5 Summary of the design review
54	Annex H (informative) Reference to the essential principles Table H.1—Correspondence between this part of ISO 80369 and the essential principles
55	Annex I (informative) Terminology—Alphabetized index of defined terms
57	Bibliography

Published By	Publication Date	Number of Pages
AAMI	2016	58


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Standard Title	ANSI/AAMI/ISO 80369-7:2016 – Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications
Published Code	AAMI
Publication Date	2016
Pages Count	58

AAMI 80369 7 2016

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