prBAS EN ISO 80369-2:2025
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications
General information
Status:Project
Number of pages:62
Adoption method:Proglašavanje
Language:engleski
Edition:1.
Realization date:08.10.2024
Forseen date for next stage code:09.10.2024
Technical committee:BAS/TC 25, Healthcare
Directives:
2017/745, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
ICS:
11.040.10, Anaesthetic, respiratory and reanimation equipment
11.040.20, Transfusion, infusion and injection equipment
11.040.20, Transfusion, infusion and injection equipment
Abstract
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.
Lifecycle
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Original document and degree of correspondence
EN ISO 80369-2:2024, identical
ISO 80369-2:2024, identical
Work material
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