DDL is now offering testing based on the recently published188appcobstandard that specifies requirements and188appcob,,,,in addition to the published parts of ISO 80369 for enteral (EnFit) and neuraxial connectors.
十多年来,一直在进行开发ISO 80369系列小孔连接器标准的工作,以最终替代ISO 594-1和ISO 594-2标准。ISO 80369-7已正式出版,ISO 594-1和594-2已撤回。
“The ISO 80369 series of standards for small-bore connectors seeks to better address patient injuries and deaths, particularly for Luers, which are used ubiquitously and on many types of incompatible devices and have contributed to many incidences of dangerous medical connections over the years,” said Levi Loesch, Product and Materials Engineer, DDL, Inc. “The timeline for transitioning from ISO 594 to 80369-7 is still to be determined by the FDA. In the meantime, DDL will offer testing to ISO 80369-7 and the other published parts of ISO 80369, while also continuing to offer ISO 594 testing.”
The sections of ISO 80369 include:
• Part 1: General Requirements
• Part 2: Connectors for breathing systems and driving gases applications
• Part 3: Connectors for enteral applications
•第4部分:连接器尿道和尿达成ications
• Part 5: Connectors for limb cuff inflation applications
•第6部分:神经应用的连接器
• Part 7: Connectors for intravascular or hypodermic applications
• Part 20: Test methods for each application
Pleasecontact usfor more information on ISO 80369 testing and other DDL test offerings.