Small Bore Connector Testing

Small Bore Connector Testing 2018-07-24T19:33:56+00:00

Whitehouse Laboratories is excited to announce that it has expanded its drug delivery and medical device testing capabilities to encompass the new ISO 80369 series. This new series provides comprehensive test methods for different types of small bore connectors—more specifically, breathing system and driving gases, enteral, urethral and urinary, limb cuff, neuraxial, and intravascular/ hypodermic connectors—for medical device and drug delivery systems. In recent years, the misconnection of different types of small bore connectors has unfortunately led to the deaths of multiple individuals. Thus, the ISO 80369 series has been created to replace ISO standards 594-1 and -2 and assure that small bore connectors of different applications can no longer connect with one another. Manufacturers of devices that include small bore connectors are encouraged to confirm that their devices comply with the ISO 80369 series in order to prevent misconnections. Whitehouse Laboratories is one of the only cGMP and ISO 17025 accredited laboratories in the United States to provide functionality testing per the current ISO 80369 standards, which are:

  • ISO 80369-3: Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications
  • ISO 80369-6: Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications
  • ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications