prBAS EN ISO 80369-2:2025
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications
Opće informacije
Status:Projekt
Broj stranica:62
Metoda usvajanja:Proglašavanje
Jezik:engleski
Izdanje:1.
Nadnevak realizacije:08.10.2024
Predviđeni nadnevak naredne faze:09.10.2024
Tehnički komitet:BAS/TC 25, Zdravstvena skrb
Direktive:
2017/745, Uredba (EU) o medicinskim sredstvima
ICS:
11.040.10, Anestezijska, respiracijska i reanimacijska oprema
11.040.20, Transfuzijska, infuzijska i injekcijska oprema
11.040.20, Transfuzijska, infuzijska i injekcijska oprema
Apstrakt
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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EN ISO 80369-2:2024, identičan
ISO 80369-2:2024, identičan
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