BSI 14/30292519 DC:2014 Edition
$13.70
BS EN ISO 80369-5. Small-bore connectors for liquids and gases in healthcare applications. Connectors for limb cuff inflation applications
| Published By | Publication Date | Number of Pages |
| BSI | 2014 | 48 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 9 | 1 * Scope 2 Normative references 3 Terms and definitions |
| 10 | 4 General requirements 4.1 General requirements for the limb cuff inflation application |
| 11 | 4.2 Material used for small-bore connectors 5 Dimensional requirements for small-bore connectors for a sphygmomanometer and cuff 5.1 * Single-lumen (S1) sphygmomanometer and cuff small-bore connectors 5.2 * Dual-lumen (S2) sphygmomanometer and cuff small-bore connectors 6 Performance requirements 6.1 * General 6.2 Air leakage |
| 12 | 6.3 * Resistance to separation from axial load |
| 13 | Annex A (informative) Rationale and guidance A.1 General guidance A.2 Rationale for particular clauses and subclauses |
| 15 | Annex B (normative) Small-bore connectors for the limb cuff inflation application |
| 21 | Annex C (normative) Reference connectors C.1 General requirements for reference connectors C.2 Single-lumen sphygmomanometer and cuff (S1) reference connectors C.3 Dual-lumen sphygmomanometer and cuff (S2) reference connectors C.3.1 General requirements for reference connectors C.3.2 Air leakage reference connectors |
| 22 | C.3.3 Resistance to separation from axial load reference connectors |
| 23 | C.3.4 Reference connector components |
| 26 | Annex D (informative) Assessment of medical devices and their attributes with connections within this application |
| 27 | Annex E (informative) Summary of usability requirements for small-bore connectors for limb cuff inflation application use E.1 User profile E.2 Use scenarios |
| 28 | E.3 Use environments and scenarios E.4 Generic user needs |
| 29 | Annex F (informative) Summary of small-bore connector criteria and requirements for limb cuff inflation connectors |
| 36 | Annex G (informative) Summary of assessment of the design of the connectors for limb cuff inflation G.1 Introduction to the assessment G.2 Summary of the engineering analysis of the design |
| 37 | G.3 Summary of the design verification G.4 Summary of the design validation G.5 Summary of the design review |
| 38 | Annex H (informative) Obsolete limb cuff inflation connector |
| 41 | Annex I (informative) Air leakage test method by pressure decay 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 |
| 42 | 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 |
| 45 | Annex K (informative) Reference to the Essential Principles |
