DIN EN 80369-5:2017-10

This standard 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 committee at DIN, the German Institute for Standardization e. V., is DIN Standards Committee Medicine (NAMed), 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"). This part of ISO 80369 specifies requirements for small-bore connectors intended to be used for connections in limb cuff inflation applications of medical devices and accessories. Limb cuff inflation applications include connections between a sphygmomanometer and its cuff. This part of ISO 80369 specifies the dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used with medical devices. This part of ISO 80369 does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.