prBAS EN ISO 80369-2:2025

Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications


Опште информације
Статус:Пројекат
Број страница:62
Метода усвајања:Proglašavanje
Језик:engleski
Издање:1.
Датум реализације:08.10.2024
Предвиђени датум наредне фазе:09.10.2024
Технички комитет:BAS/TC 25, Заштита здравља
Директиве:
2017/745, Уредба (ЕU) о медицинским средствима
ICS:
11.040.10, Aнeстeзиjскa, рeспирaциjскa и рeaнимaциjскa oпрeмa
11.040.20, Tрaнсфузиjскa, инфузиjскa и ињeкциjскa oпрeмa

Абстракт
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.

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Изворни документ и степен усаглашености
EN ISO 80369-2:2024, идентичан
ISO 80369-2:2024, идентичан

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