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ANSI/AAMI/ISO 80369-3:2016 - Small-bore connectors for liquids and gases in healthcare applications-Part 3: Connectors for enteral applications., 2016
- ANSI/AAMI/ISO 80369-3:2016; Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications
- Objectives and uses of AAMI standards and recommended practices
- AAMI Standard
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Background on ANSI/AAMI adoption of ISO 80369-3:2016
- Foreword
- Introduction
- 1 * Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements [Go to Page]
- 4.1 General requirements for the enteral application
- 4.2 Material used for enteral small-bore connectors
- 4.3 Type tests
- 5 Dimensional requirements for enteral small-bore 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 Stress cracking
- 6.3 Resistance to separation from axial load
- 6.4 Resistance to separation from unscrewing
- 6.5 Resistance to overriding
- 6.6 Disconnection by unscrewing
- Annex A (informative) Rationale and guidance [Go to Page]
- A.1 General guidance [Go to Page]
- A.1.1 Guidance
- A.1.2 Connector selection
- A.1.3 Colour coding
- A.2 Rationale for particular clauses and subclauses
- Annex B (normative) Enteral small-bore connectors [Go to Page]
- Figure B.1—Male E1 small-bore connector
- Table B.1—Male E1 small-bore connector dimensions
- Figure B.2—Female E1 small-bore connector
- Figure B.3—E1 connector assembly
- Annex C (normative) Reference connectors [Go to Page]
- C.1 General requirements for reference connectors
- C.2 Reference connectors [Go to Page]
- Figure C.1—Female reference CONNECTOR for testing male ENTERAL CONNECTOR for leakage, disconnection byunscrewing, separation from unscrewing, stress cracking, and NON-INTERCONNECTABLE characteristics
- Figure C.2—Female reference connector for testing male enteral connector for separation from axial load, resistance to overriding, and non-interconnectable characteristics
- Figure C.3—Male reference connector for testing female enteral connector for leakage, disconnection by unscrewing, separation from unscrewing, stress cracking, and non-interconnectable characteristics
- Figure C.4—Male reference CONNECTOR for testing female ENTERAL CONNECTOR for separation from axial load,resistance to overriding, and NON-INTERCONNECTABLE characteristics
- Annex D (informative) Assessment of medical devices and their attributes with connections within this application [Go to Page]
- Table D.1—Examples of medical devices with connections within this application and their attributes
- Annex E (informative) Summary of the usability requirements for small-bore connectors for enteral 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, enteral feeding
- Table E.3—Use scenarios, medication delivery
- Table E.4—Use scenarios, decompression, and suction of GI content
- Table E.5—Use scenarios, delivery of radiologic contrast material
- 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 small-bore connector criteria and requirements for enteral applications [Go to Page]
- Table F.1—Enteral connector-specific design criteria and requirements
- Annex G (informative) Summary of assessment of the design of the connectors for enteral 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 E1 male to N1 male
- G.2.3 E1 female to luer slip connector female
- G.2.4 E1 female to N1 female
- G.3 Summary of the design verification
- G.4 Summary of the design validation [Go to Page]
- G.4.1 General
- G.4.2 Test procedure
- G.4.3 Test participants
- G.4.4 Test results [Go to Page]
- Table G.2—Summary of findings for the failed participant
- G.4.5 Summative validation study conclusions
- 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]