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eLibrary > ANSI/AAMI/ISO 80369-1:2018 - Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements. >

ANSI/AAMI/ISO 80369-1:2018 - Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements., 2018

ANSI/AAMI/ISO 80369-1:2018; Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements
Title page
AAMI Standard
Copyright information
Contents
Committee representation
Background of ANSI/AAMI adoption of ISO 80369-1:2018
Foreword
Introduction
1 *Scope
2 *Normative references
3 Terms and definitions
4 *Materials
5 Small-bore connector incompatibility
6 *Clinical applications [Go to Page]
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
7 *Alternative small-bore connectors
Annex A (informative) Rationale
Annex B (normative) Test methods for demonstrating non-interconnectable characteristics [Go to Page]
B.1 Principle
B.2 Dimensional analysis test method [Go to Page]
B.2.1 General
B.2.2 Requirements
B.2.3 Identification of potential contactable surface diameters and features [Go to Page]
Figure B.1—Example of typical fixed collar male connector diameters to be evaluated
Figure B.2—Example of typical full threaded female connector diameters to be evaluated
Figure B.3—Example of a typical rib diameter to be evaluated
Figure B.4—Example of a typical connector with a lug to be evaluated
Figure B.5—Example of a typical cylinder-to-cylinder interface to be evaluated
Figure B.6—Example of a typical cylinder to full thread interface to be evaluated
Figure B.7—Example of a typical cylinder to full thread interface to be evaluated (cross-section view)
Figure B.8—Example of a typical cylinder to external lug interface to be evaluated
Figure B.9—Example of a typical cylinder to external lug interface to be evaluated (cross-section view)
Figure B.10—Example 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 [Go to Page]
Figure B.11—Example 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 [Go to Page]
Table B.1—Dimensional analysis from the equation results
Table B.2 —Misconnection interference limits
B.3 Physical test methods [Go to Page]
B.3.1 General
B.3.2 *Requirements
B.3.3 Small-bore connector under evaluation
B.3.4 Target interference connector or feature
B.3.5 Mechanical test method [Go to Page]
B.3.5.1 Apparatus
B.3.5.2 Test sample preconditioning
B.3.5.3 Procedure
B.3.6 Leak test method [Go to Page]
B.3.6.1 Apparatus
B.3.6.2 Test sample preconditioning
B.3.6.3 Procedure [Go to Page]
Figure B.12—Leak TEST METHOD set up
Annex C (informative) Symbols and safety signs [Go to Page]
Table C.1—Safety sign
Annex D (normative) Assessment procedures small-bore connectors [Go to Page]
D.1 General [Go to Page]
D.1.1 Request to include a new design
D.1.2 Intellectual Property Rights
D.2 * Design proposal
D.3 Engineering analysis [Go to Page]
D.3.1 Design
D.3.2 Design realization
D.3.3 Design verification
D.3.4 Design validation
D.4 Design review
Annex E (informative) Applications of small-bore connectors [Go to Page]
Table E.1—Applications of small-bore connectors
Annex F (informative) Reference to the Essential Principles [Go to Page]
Table F.1—Correspondence between this document and the essential principles
Bibliography
Alphabetized index of defined terms [Go to Page]

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