Medizinisches System und Verfahren zur Sterilitätsprüfung des Medizinischen Systems

Details

Veröffentlichungs-Nr.

EP3871602

Aktenzeichen

EP20159511

Anmeldetag

26. Februar 2020

Veröffentlichung

27. September 2023

Erteilung

27. September 2023

Rechtsraum

EP

IPC

A61B5/145A61B5/00A61L2/28

Abstract

The invention discloses a medical system (144). The medical system (144) comprises:i) a housing (146);ii) a preassembled functional module (110) received in the housing (146), the preassembled functional module (110) comprisinga. an analyte sensor (112) for detecting at least one analyte in a body fluid of a user;b. an electronics unit (120) electrically connected to the analyte sensor (112); andc. an insertion component (114) for inserting the analyte sensor (112) into a body tissue of the user; andiii) at least one removable protective cap (148) connected to the housing (146), covering the preassembled functional module (110),wherein the preassembled functional module (110) further comprises at least one sterility cap (116), which at least partially surrounds the insertion component (114), wherein the at least one sterility cap (116) is at least partially surrounded by the protective cap (148),wherein the sterility cap (116) comprises at least one sterility testing access (140), the sterility testing access (140) comprising at least one of a septum (142) and a multiple-step sealing (162). Further, methods of providing the medical system (144) and of sterility testing of the medical system (144) are disclosed.

Anmelder

Firmen

Roche Diabetes Care GmbH
F. Hoffmann-La Roche AG

Land

🇩🇪 Deutschland

Fachgebiete