AAMI 80369 5 2016
$115.49
ANSI/AAMI/ISO 80369-5:2016 – Small-bore connectors for liquids and gases in healthcare applications – Part 5: Connectors for limb cuff inflation applications
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 47 |
Specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in limb cuff inflation applications of medical devices and accessories. Limb cuff inflation applications include connections between a sphygmomanometer and its cuff.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 80369-5:2016, Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation 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 80369-5:2016 |
| 10 | Foreword |
| 12 | Introduction |
| 13 | 1 * Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 15 | 4 General requirements 4.1 General requirements for the limb cuff inflation application |
| 16 | 4.2 Materials used for small-bore connectors 4.3 Type tests 5 Dimensional requirements for sphygmomanometer and cuff small-bore connectors 5.1 * Requirements for adult or paediatric patient small-bore connectors (S1) 5.2 Void 6 Performance requirements 6.1 Air leakage 6.2 * Resistance to separation from axial load |
| 17 | Annex A (informative) Rationale and guidance A.1 General guidance A.2 Rationale for particular clauses and subclauses |
| 19 | Annex B (normative) Small-bore connectors for the limb cuff inflation application Figure B.1 – Male cuff S1 SMALL-BORE CONNECTOR |
| 20 | Table B.1 – Male cuff S1 SMALL-BORE CONNECTOR dimensions |
| 21 | Figure B.2 – Female sphygmomanometer S1 SMALL-BORE CONNECTOR Figure B.3 – Sphygmomanometer and cuff SMALL-BORE CONNECTOR (S1) assembly |
| 22 | Table B.2 – Female sphygmomanometer S1 SMALL-BORE CONNECTOR dimensions |
| 23 | Annex C (normative) Reference connectors C.1 General requirements for reference connectors C.2 * Sphygmomanometer and cuff S1 reference connectors |
| 24 | Annex D (informative) Assessment of medical devices and their attributes with connections within this application |
| 25 | Annex E (informative) Summary of the usability requirements for small-bore connectors for limb cuff inflation applications E.1 User profile Table E.1 – USER PROFILE |
| 26 | E.2 Use scenarios E.3 Use environments and scenarios E.4 Generic user needs |
| 27 | Annex F (informative) Summary of small-bore connector design requirements for limb cuff inflation applications Table F.1 – Adult or paediatric PATIENT sphygmomanometerand cuff S1 CONNECTOR-specific design requirements |
| 31 | Table F.2 – Neonatal sphygmomanometer and cuff CONNECTOR-specificdesign requirements |
| 35 | Annex G (informative) Summary of assessment of the design of the connectors for limb cuff inflation application 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 G.2.2 S1 male to N1 male G.3 Summary of the design verification |
| 36 | G.4 Summary of the design validation G.5 Summary of the design review |
| 37 | Annex H (informative) Obsolete limb cuff inflation connector |
| 38 | Figure H.1 – Obsolete sphygmomanometer and cuff SMALL-BORE CONNECTOR |
| 39 | Table H.1 – Obsolete male sphygmomanometerand cuff SMALL-BORE CONNECTOR dimensions Table H.2 – Obsolete female sphygmomanometerand cuff SMALL-BORE CONNECTOR dimensions |
| 40 | Annex I (informative) Air leakage by pressure decay test method I.1 Principle I.2 * Test conditions I.2.1 Test sample preconditioning I.2.2 Environmental test conditions I.3 Apparatus I.4 Procedure |
| 41 | I.5 Test report |
| 43 | Annex J (informative) Resistance to separation from axial load test method J.1 Principle J.2 * Test conditions J.2.1 Test sample preconditioning J.2.2 Environmental test conditions J.3 Apparatus J.4 Procedure J.5 Test report |
| 44 | Annex K (informative) Reference to the essential principles Table K.1 – Correspondence between this documentand the essential principles |
| 46 | Index of defined terms |
| 47 | Bibliography |
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