DIN EN ISO 80369-7:2017-10

The DIN EN ISO 80369 series of standards has been prepared to prevent the incorrect connection of small-bore connectors for use in various applications. Part 1 of the series of standards documents the required measures and procedures in order to prevent incorrect connections and defines the applications. Part 20 contains the general test methods to support the functional requirements for small-bore connectors. The other parts define the designs of small-bore connectors for the individual applications. This Part 7 of the ISO 80369 series of standards defines the requirements for small-bore connectors intended for use in intravascular or hypodermic applications of medical devices and accessories. It specifies dimensions and performance requirements for these small-bore connectors. This part of ISO 80369 does not specify the dimensions or requirements for the medical devices or accessories with which these connectors are used. Such requirements are given in particular standards for specific medical devices or accessories. The connector in accordance with DIN EN ISO 80369-7 was designed for pressures up to 300 kPa. This document (EN ISO 80369-7:2017) has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices" (secretariat: ANSI, USA) in collaboration with Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices" (secretariat: NEN, Netherlands) with the participation of German experts. The responsible national committee is Working Committee NA 063-01-11 AA "Kleinlumige Konnektoren für Flüssigkeiten und Gase zur Verwendung im Gesundheitsbereich" ("Small bore connectors for liquids and gases in health care applications") at DIN Standards Committee Medicine (NAMed).