AAMI 80369 6 2016
$140.32
ANSI/AAMI/ISO 80369-6:2016 – Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 59 |
Specifies requirements for SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in neuraxial APPLICATIONS. Neuraxial APPLICATIONS involve the use of MEDICAL DEVICES intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 80369-6:2016, Small-bore connectors for liquids and gases in healthcare applications— Part 6: Connectors for neuraxial applications |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 9 | Background of ANSI/AAMI/ISO 80369-6:2016 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 * Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 15 | 4 General requirements 4.1 General requirements for the neuraxial application |
| 16 | 4.2 * Material used for small-bore connectors 4.3 Type tests 5 Dimensional requirements for neuraxial small-bore connectors 6 Performance requirements 6.1 Fluid leakage 6.1.1 Fluid leakage requirement 6.1.2 Leakage by pressure decay 6.1.3 Positive pressure liquid leakage 6.2 Subatmospheric pressure air leakage |
| 17 | 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: Rationale and guidance A.1 General guidance A.2 Rationale for particular clauses and subclauses |
| 22 | Annex B: * Small-bore connectors for neuraxial applications Figure B.1 — Male neuraxial slip connector (N1) Table B.1 — Male neuraxial SLIP CONNECTOR dimensions (N1) |
| 24 | Figure B.2 — Male neuraxial lock connector (N2) |
| 25 | Table B.2 — Male neuraxial lock connector dimensions (N2) |
| 26 | Figure B.3 — Male neuraxial lock connector with rotatable collar (N2) |
| 27 | Table B.3 — Male neuraxial lock connector with rotatable collar dimensions (N2) Figure B.4 — Female neuraxial LOCK CONNECTOR (N2) |
| 28 | Table B.4 — Female neuraxial lock connector dimensions (N2) |
| 29 | Figure B.5 — Female neuraxial lock connector with lugs (N2) Table B.5 — Female neuraxial lock connector with lugs dimensions (N2) |
| 31 | Annex C: Reference connectors for testing small-bore connectors for neuraxial applications C.1 General requirements for reference connectors |
| 32 | C.2 Reference connectors Figure C.1 — Female reference LOCK CONNECTOR for testing male neuraxial CONNECTORS for leakage, separation from unscrewing, stress cracking and NON-INTERCONNECTABLE characteristics |
| 33 | Figure C.2 — Male reference SLIP CONNECTOR for testing female neuraxial CONNECTORS for leakage, stress cracking and NON-INTERCONNECTABLE characteristics |
| 34 | Figure C.3 — Female reference CONNECTOR for testing male neuraxial CONNECTORS for separation from axial load and resistance to overriding |
| 35 | Figure C.4 — Male reference LOCK CONNECTOR for testing female neuraxial CONNECTORS for leakage, separation from unscrewing, stress cracking and NON-INTERCONNECTABLE characteristics |
| 36 | Figure C.5 — Male reference connector for testing female neuraxial lock connectors from axial load and resistance to overriding |
| 38 | Annex D: Assessment of medical devices and their attributes with connections within this application |
| 39 | Table D.1 — Examples of medical devices with connections within this application and their attributes |
| 40 | Annex E: Summary of the usability requirements for small-bore connectors for neuraxial applications E.1 User profile Table E.1 — USER PROFILE E.2 Use scenarios |
| 41 | Table E.2 — Use scenarios E.3 Use environments E.3.1 Facilities E.3.2 Use temperatures E.4 Other attributes |
| 42 | E.5 Generic user needs |
| 43 | Annex F: Summary of small-bore connector design requirements for neuraxial applications Table F.1 — Neuraxial connector — specific design requirements |
| 47 | Annex G: Summary of assessment of the design of the small bore connectors for neuraxial 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 |
| 48 | G.2.2 N1 male to E1 male G.2.3 N1 male to S1 male G.2.4 N1 male to luer connector male Figure G.1 — Illustration of N1 male to LUER CONNECTOR male misconnection G.2.5 N2 male to luer slip connector female G.2.6 N2 female to E1 female |
| 49 | G.3 Summary of the design verification G.4 Summary of the design validation |
| 50 | G.4.1 Usability misconnection evaluation G.5 Summary of the design review |
| 51 | Annex H: Mechanical tests for verifying non-interconnectable characteristics H.1 * Purpose H.2 Requirement H.3 Test method H.4 Test procedure, physical force H.4.1 Apparatus H.4.2 Procedure |
| 52 | H.5 * Test procedure, connector incompatibility (gross leakage) H.5.1 Apparatus H.5.2 Procedure |
| 54 | Annex I: Reference to the essential principles Table I.1 — Correspondence between this document and the essential principles |
| 56 | Annex J: Terminology — alphabetized index of defined terms |
| 58 | Bibliography |
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