AAMI 80369 1 2018
$75.64
ANSI/AAMI/ISO 80369-1:2018 – Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements.
| Published By | Publication Date | Number of Pages |
| AAMI | 2018 | 43 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 80369-1:2018; Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 8 | Background of ANSI/AAMI adoption of ISO 80369-1:2018 |
| 9 | Foreword |
| 10 | Introduction |
| 13 | 1 *Scope |
| 14 | 2 *Normative references 3 Terms and definitions |
| 16 | 4 *Materials 5 Small-bore connector incompatibility |
| 17 | 6 *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 |
| 18 | 7 *Alternative small-bore connectors |
| 19 | Annex A (informative) Rationale |
| 22 | Annex 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 |
| 23 | 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 |
| 24 | 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 |
| 25 | 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 |
| 26 | 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) |
| 27 | 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 |
| 28 | 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 |
| 29 | Table B.1—Dimensional analysis from the equation results Table B.2 —Misconnection interference limits |
| 30 | B.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 |
| 31 | B.3.5 Mechanical test method B.3.5.1 Apparatus B.3.5.2 Test sample preconditioning B.3.5.3 Procedure |
| 32 | B.3.6 Leak test method B.3.6.1 Apparatus B.3.6.2 Test sample preconditioning B.3.6.3 Procedure |
| 34 | Figure B.12—Leak TEST METHOD set up |
| 35 | Annex C (informative) Symbols and safety signs Table C.1—Safety sign |
| 36 | Annex 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 |
| 37 | D.3.2 Design realization D.3.3 Design verification D.3.4 Design validation D.4 Design review |
| 38 | Annex E (informative) Applications of small-bore connectors Table E.1—Applications of small-bore connectors |
| 40 | Annex F (informative) Reference to the Essential Principles Table F.1—Correspondence between this document and the essential principles |
| 41 | Bibliography |
| 43 | Alphabetized index of defined terms |
