DANSK DSF/PREN ISO 80369-1 PDF

NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2. This document specifies general requirements for small-bore connectorsthat form part of a medical device or accessory that conveys liquids or gases to a patient. This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to: – respiratory; – enteral; – limb cuff inflation; – neural; – intravascular or hypodermic. This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that might be developed under future parts of the ISO and IEC 80369 series. This document specifies the small-bore connector-related interface requirements for the medical devices and accessories that use these small-bore connectors.