What ever happened to ISO 594?

In any industry, standards that have been in place for many years sometimes get replaced by entirely new documents as technology or requirements change.  That’s the case with the ISO 594 series on Luer Connectors for Medical Devices.  Over the years, industry realized that existing standards were not meeting current risk management benchmarks.  So the ISO 80369 standards (ISO 80369-7 specifically) for small-bore connectors for liquids and gases in healthcare applications are being developed.  Let’s take a look at the new documents and discuss the rationale for the new publications.

Medical Device manufacturers and health care professionals have committed to the principles of identifying hazards and risks posed by both intended use and foreseeable misuse, and to eliminate or reduce such risks by safe design and construction.  So for small bore connectors used in healthcare, the ISO 80369 provides guidance using this new concept.

The overview standard, ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements, replaces the EN 15546-1.  It contains general requirements to be used with the other parts.  It explains that the series is being produced to avoid mis-connection between small bore connectors used in different applications.  In the introduction, the committee points out that in some coronary care units, there can be as many as 40 luer connections used on medical devices for just 1 patient!  No wonder the industry decided to find a systemic solution for the problem.

It is the intention of the joint working group that has oversight of these publications to deliver a total of 8 standards for the series.  So far an additional 4 have been released. Let’s take a look.

ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications.  This publication was developed to help avoid catastrophic mistakes involving either medication errors into the alimentary canal, or administration of enteral solutions via incorrect routes.  There was no previous standard on this.

ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications.  Issued for similar reasons to the Part 3 — With the errors involving vincristine in this case.

ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications.  This is the part of the series that specifically replaces both the ISO 574-1 and the ISO 574-2.  The material in the older standards is consolidated and technically revised.  There are 4 major technical updates identified by the authoring committee:

  • New terms and definitions better define various luer connections,
  • Requirements are included for new dimensions, developed specifically to reduce the mis-connection risks the series aims to mitigate,
  • Older gauging requirements have been replaced by dimensional ones.  Again, this results in more precision (necessary for risk reduction), and
  • Division of requirements for semi-rigid material connectors and those made from rigid materials is now part of the standard.

The more rigorous design requirements are specifically included to make sure that the increased number of connectors, each for a specific use, cannot mate incorrectly.   And these new specifications will also insure that correct connections will be safe and secure.

ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods.  This was the second standard in the series to be issued.  It specifies the test methods you should use in order to evaluate the performance of any ISO 80369 connectors.  Validating performance through the use of appropriate test methods is essential to confirming your design choices.  Failure to do so may result in non-conformance, which in the case of these connectors can lead to catastrophic results.

What other standards are expected in this series?  Here are the Parts which are not completed at this time:

Part 2:  Connectors for breathing systems and driving gases applications

Part 4:  Connectors for urethral and urinary applications

Part 5:  Connectors for limb cuff inflation applications

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