DIN EN ISO 80369-1:2011-04

This part of ISO 80369 specifies general requirements for small bore connectors which convey liquids or gases in healthcare applications. These small bore connectors are used in medical devices or accessories intended for use with a patient. This International Standard also specifies the healthcare fields in which these small bore connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications for - breathing systems and driving gases, - enteral and gastric applications, - urethral and urinary applications, - applications for limb cuff inflation, - neuraxial devices, and - intravascular or hypodermic applications. Small bore connectors as specified in this International Standards are non-interconnectable with: - the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; - the temperature sensor connector and mating ports specified in Annex DD of ISO 8185:2007; and - the nipples of EN 13544-2:2002. This International Standard provides the methodology to assess non-interconnectable characteristics of small bore connectors based on their inherent design and dimensions in order to reduce to risk of misconnections between medical devices or between accessories for different applications and to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed under future parts of this series of standards. This standard does not specify requirements for the medical devices or accessories that use these small bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. The European Standard EN ISO 80369-1 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" and with the participation of German experts. At DIN, the German Institute for Standardization e. V., the Committee responsible for the standard is the Medical Standards Committee (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").