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ANSI/AAMI/ISO 80369-7:2016 - Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications, 2016
- ANSI/AAMI/ISO 80369-7:2016;2016Small-bore connectors for liquids and gases in healthcare applications—Part 7: Connectors for intravascular or hypodermic applications
- Objectives and uses of AAMI standards andrecommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Background of AAMI/ISO 80369-7:2016
- Foreword
- Introduction
- 1 * Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements [Go to Page]
- 4.1 General requirements for luer connectors
- 4.2 Material used for luer connectors
- 4.3 Type tests
- 5 * Dimensional requirements for luer connectors
- 6 Performance requirements [Go to Page]
- 6.1 Fluid leakage [Go to Page]
- 6.1.1 Fluid leakage requirement
- 6.1.2 Leakage by pressure decay
- 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
- Annex A (informative) Rationale and guidance
- A.1 General guidance
- A.2 Rationale for particular clauses and subclauses [Go to Page]
- Figure A.1—Lug corners that can interfere
- Figure A.2—Area of potential interference
- Annex B (normative) luer connectors [Go to Page]
- Figure B.1—Male luer slip connector (L1)
- Table B.1—Male luer slip connector dimensions (L1)
- Figure B.2—Female luer slip connector (L1)
- Table B.2—Female luer slip connector dimensions (L1)
- Figure B.3—Male luer lock connector (L2), with fixed collar
- Table B.3—Male luer lock connector with fixed collar dimensions (L2)
- Figure B.4—Male luer lock connector (L2), with rotatable collar
- Table B.4—Male luer lock connector with a rotatable collar dimensions (L2)
- Figure B.5—Female luer lock connector (L2)
- Table B.5—Female luer lock connector dimensions (L2)
- Figure B.6—Female luer lock connector with lugs at right angle to axis (L2), variant A
- *Table B.6—Female luer lock connector dimensions (L2), variant A
- Figure B.7—Female luer lock connector with lugs at right angle to axis (L2), variant B
- 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
- Table B.8—Female luer lock connector dimensions (L2), variant C
- Annex C (normative) Reference connectors
- C.1 General requirements for reference connectors
- C.2 Reference connectors [Go to Page]
- Figure C.1—Female reference luer lock connector for testing male luer connectors for leakage, separation from unscrewing, stress cracking and non-interconnectable characteristics
- 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
- Figure C.3—Female reference connector for testing male luer lock connector for separation from axial load and resistance to overriding
- Figure C.4—Male reference luer lock connector for testing female luer connectors for leakage, separation from unscrewing, stress cracking and non-interconnectable characteristics
- 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
- Figure C.6—Male reference connector for testing female luer lock connector for separation from axial load and resistance to overriding
- Annex D (informative) Assessment of medical devices and their attributes with connections within this application
- Table D.1—Examples of medical devices with connections within this application and their attributes
- Annex E (informative) Summary of the usability requirements for luer connectors for intravascular or hypodermic applications [Go to Page]
- E.1 user profile [Go to Page]
- Table E.1—User profile
- E.2 Use scenarios [Go to Page]
- Table E.2—Use scenarios
- E.3 Use environments [Go to Page]
- E.3.1 Facilities
- E.3.2 Use temperature
- E.4 Other attributes
- E.5 Generic user needs
- Annex F (informative) Summary of luer connector design requirements for intravascular or hypodermic applications [Go to Page]
- Table F.1—Luer connector specific design requirements for intravascular or hypodermic applications
- Annex G (informative) Summary of assessment of the design of the luer connector for intravascular or hypodermic applications [Go to Page]
- G.1 General
- G.2 Summary of the engineering analysis of the design [Go to Page]
- G.2.1 non-interconnectable analysis [Go to Page]
- Table G.1—Summary of possible misconnection from CAD analysis
- G.2.2 luer connector male to N1 male [Go to Page]
- 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
- G.4 Summary of the design validation
- G.5 Summary of the design review
- Annex H (informative) Reference to the essential principles [Go to Page]
- Table H.1—Correspondence between this part of ISO 80369 and the essential principles
- Annex I (informative) Terminology—Alphabetized index of defined terms
- Bibliography [Go to Page]