DIN EN ISO 80369-3:2016-12

The DIN EN ISO 80369 series of standards has been developed to prevent connection failures when using small-bore connectors for various medical applications. Part 1 of the series of standards specifies the general requirements and defines the concept on which the series of standards is based, Part 20 contains the required test methods to support the functional requirements for small-bore connectors and the other parts specify the designs of the connectors for the individual applications. This part of the DIN EN ISO 80369 series of standards applies to small-bore connectors used for medical devices and their accessories for enteral applications. These medical devices include, for example, enteral feeding sets, enteral drainage sets and connection ports. The dimensions and design of the connectors, the functional requirements and, with reference to Part 20 of this series of standards, the required test methods are specified. This standard has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices" in collaboration with Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices" 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).