BS EN ISO 80369-2:2024
$198.66
Small-bore connectors for liquids and gases in healthcare applications – Connectors for respiratory applications
| Published By | Publication Date | Number of Pages |
| BSI | 2024 | 68 |
This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing). NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected. NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories within this application. NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1. This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards. NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 8 | Annex ZA(informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered |
| 14 | Foreword |
| 15 | Introduction |
| 17 | 1 Scope 2 Normative references |
| 18 | 3 Terms and definitions |
| 19 | 4 Non-interconnectability requirements 5 Material requirements 6 Dimensions and tolerances 6.1 R1 small-bore connectors 6.2 R2 small-bore connectors |
| 20 | 7 Performance requirements 7.1 Leakage by pressure decay 7.2 Sub-atmospheric pressure air leakage 7.3 Stress cracking 7.4 Resistance to separation from axial load 7.5 Resistance to separation from unscrewing |
| 21 | 7.6 Resistance to overriding 7.7 Disconnection by unscrewing |
| 22 | Annex A (informative) Rationale and guidance |
| 23 | Annex B (normative) Small-bore connectors for respiratory applications |
| 32 | Annex C (normative) Reference connectors for testing small-bore connectors for respiratory applications |
| 47 | Annex D (informative) Assessment of medical devices and their attributeswith connections within this application |
| 53 | Annex E (informative) Summary of the usability requirements for small-bore connectors for respiratory applications |
| 55 | Annex F (informative) Summary of small-bore connector design requirementsfor respiratory applications |
| 61 | Annex G (informative) Summary of assessment of the design of the small-bore connectorsfor respiratory applications |
| 64 | Annex H (informative) Reference to the IMDRF essential principles |
| 65 | Annex I (informative) Terminology — Alphabetized index of defined terms |
| 66 | Bibliography |
