AAMI ISO 80369-1:2018 pdf download – Small-bore connectors for liquids and gases in healthcare applications
To prevent misconnection between MEDICAL DEVICES that should not connect, the rigidity of the materials from which SMALL – BORE CONNECTORS are made has been specified to eliminate the possibility of forcing a fit between incompatible SMALL – BORE CONNECTORS made from flexible materials. To achieve this, the committee determined that the previous semi-rigid requirement had to be increased to a more rigid (greater than 700 MPa) material. NOTE ISO 80369-6 requires the NOMINAL modulus of elasticity to be greater than 950 MPa.
It is understood that SMALL – BORE CONNECTOR systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse. For example, the possibility of the misconnection of a SMALL – BORE CONNECTOR to a specialized PATIENT -access port can still exist. Specialized PATIENT -access ports often require the use of flexible materials which are intended to permit access by a range of MEDICAL DEVICES or ACCESSORIES , such as, endoscopes, bronchoscopes, and surgical instruments. These access ports can permit interconnection with some SMALL – BORE CONNECTORS . The RISKS associated with the use of these specialized PATIENT -access ports are not addressed by this document. M ANUFACTURERS of MEDICAL DEVICES or ACCESSORIES and the committees responsible for the development of standards for MEDICAL DEVICES or ACCESSORIES that incorporate these specialized PATIENT -access ports will need to assess these RISKS.
National regulatory bodies, hospital accreditation organizations, and independent public health organizations recognize misconnections as a persistent problem with potentially lethal consequences. Warnings have been issued and strategies have been offered for healthcare organizations to reduce RISKS and MANUFACTURERS to redesign CONNECTORS to prevent misconnections. The ability of CONNECTORS to interconnect is identified as a root cause of misconnections. CEN Report, CR 13825 [12] , identifies possible misconnections between MEDICAL DEVICES involving the conveyance of a gas or liquid for the different APPLICATION categories and classifies each according to the SEVERITY of the HARM that can occur. The report confirms that the APPLICATION categories specified in this document are incompatible, i.e. misconnections among these APPLICATION categories can cause serious injury or death. The committee reviewed this report and agreed that these APPLICATION categories were the highest areas of RISK to public health from MEDICAL DEVICE misconnection if a misconnection were to occur. This determination comes from years of adverse event reports, literature reviews and research on MEDICAL DEVICE misconnection. It is noted that the identified APPLICATION categories do not encompass all medical areas to which MEDICAL DEVICES are intended to be used and therefore, all potential areas of misconnection might not be addressed by this document. It is intended that the APPLICATION categories in this clause represent a majority of MEDICAL DEVICES containing SMALL – BORE CONNECTORS and therefore, the use of these SMALL – BORE CONNECTORS will bring the RISK of misconnection to an acceptable level. This clause specifies the APPLICATIONS for each of the standard series parts. The purpose of including these APPLICATIONS is to reduce the RISK of misconnection between these categories to a minimum.