UNE-EN ISO 80369-1:2019

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:¾ðBREATHING SYSTEMS and driving gases,¾ðenteral,¾ðurethral and urinary,¾ðlimb cuff inflation,¾ðneuraxial devices, and¾ðintravascular or hypodermic.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 the 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 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.NOTE 1Subclause 5.8 allows for additional designs of SMALL-BORE CONNECTORS for inclusion in this series of standards for APPLICATIONS other than those already specified. NOTE 2MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this series of standards into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised, requirements for SMALL-BORE CONNECTORS as specified in the series of standards will be included.NOTE 3MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL-BORE CONNECTORS specified in this series of standards to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of this series of standards.