In the 1990s, concern grew as increasing numbers of misconnections using Luer connectors were reported. In response, the International Organization for Standardization (ISO) introduced ISO 80369 which consists of eight parts with one part (ISO 80369-1) addressing general requirements, six parts (ISO 80369-2 through -7) addressing specific applications and one part (ISO 80369-20) addressing general test methods.
Since the publication of the ISO 80369 series of standards, additional medical connector standards have been developed.
ISO 80369-1 Test Standard for Small-Bore Connectors for Liquids and Gases
“Small-bore connectors for liquids and gases in healthcare applications – Part 1: General Requirements” introduces its intent, defines the six connectors’ applications, provides terms and definitions and outlines the procedure that ISO will use to determine the final designs to be used in ISO 80369-2 through ISO 80369-7.
The applications:
Part 2: Connectors for breathing systems and driving gases applications
Part 3: Connectors for enteral applications
Part 4: Connectors for urethral and urinary applications
Part 5: Connectors for limb cuff inflation applications
Part 6: Connectors for neuraxial applications
Part 7: Connectors for intravascular or hypodermic applications
One critical component to the ISO 80369 series is Annex B in ISO 80369-1. Annex B, titled, “Mechanical tests for verifying non-interconnectable characteristics” provides test methods intended to demonstrate that two connectors intended for different applications cannot be connected.
In an effort to address our customers’ needs to demonstrate compliance with Annex B of ISO 80369-1, DDL has purchased axial/torsion (biaxial) test systems that can perform the assembly procedure prescribed by the test method.
ISO 80369-2 to ISO 80369-7 Application Standards for Small-Bore Connectors for Liquids and Gases
The applications:
Part 2*: Connectors for breathing systems and driving gases applications
Part 3: Connectors for enteral applications
Part 4*: Connectors for urethral and urinary applications
Part 5: Connectors for limb cuff inflation applications
Part 6: Connectors for neuraxial applications
Part 7: Connectors for intravascular or hypodermic applications
*At this time ISO 80369-2 is under development. Work on ISO 80369-4 has not commenced.
Each standard contains the dimensional requirements and acceptance criteria for the general performance tests contained in ISO 80369-20. The most familiar method for performance characteristics of medical device connectors, ISO 594, was replaced by ISO80369-7 upon its publication, which improves upon many aspects of the standard.
DDL offers both attribute and variable testing to these standards, depending on our customers’ needs. In order to quickly turnaround ISO 80369 testing projects, DDL owns one of the largest collections of calibrated reference fittings in the testing industry. To further support the quality of the data DDL provides, we have validated our internal test methods and have added the ISO 80369-20 tests to the scope of our ISO 17025 accreditation.
Many additional industry standards require testing per ISO 80369-7 including ISO 7864, ISO 7886, ISO 8536, ISO 8537, ISO 10555, ISO 11040-4, ISO 11040-6 and ISO 11070
ISO 80369-20: General Methods for Small-Bore Connector Testing for Liquids and Gases
SO 80369-20 defines all of the general test methods which are referenced by the various application standards. Many of the test methods are based on those in ISO 594, but with modification to reduce the subjectivity of the tests (for example, performing a leakage test to determine the presence of stress cracking rather than a visual inspection) and to allow for variable testing which can reduce the required number of samples in order to achieve the same confidence intervals as an attribute test.
Overview of Non-Interconnectability Testing Requirements for ISO 80369 & AAMI CN27
ISO 594 and EN Luer Standards (WITHDRAWN)
The ISO committee withdrew ISO 594-1 and ISO 594-2 with the publications of ISO 80369-7 and ISO 80369-20. Please confirm with your regulatory body which standard is appropriate for your device.
Conical Luer fittings are used in many medical devices, including hypodermic needles, syringes, catheters and infusion sets. A Luer fitting is the most common means of achieving a leak-free connection between two medical devices that carry small volumes of fluids.
DDL Offers Testing to the Following Luer Standards:
- ISO 594-1 Conical fittings with 6% (Luer) taper – Part 1: General requirement
- ISO 594-2 Conical fittings with 6% (Luer) taper – Part 2: Lock Fittings
- ISO 18250-3 Medical devices — Connectors for reservoir delivery systems for healthcare applications
Part 3: Enteral applications - EN 1707 Conical fittings with 6% (Luer) taper – for syringes, needles and certain other medical equipment – Lock Fittings
- EN 20594-1 Conical fittings with 6% (Luer) taper – for syringes, needles and certain other medical equipment – Part1: General Requirements
In order to quickly turnaround Luer testing projects, DDL owns one of the largest collections of calibrated reference fittings in the testing industry. To further support the quality of the data DDL provides, we have validated our internal test methods and have added the ISO 594 tests to the scope of our ISO 17025 accreditation.
DDL has tested Luer fittings for many companies seeking to market their products in the United States, Europe, Asia and elsewhere.
ISO 18250 Application Standards for Reservoir Delivery Systems
In 2018 the ISO committee released the ISO 18250 series of standards for connectors used in reservoir delivery system applications. Below are the standards offered by DDL.
- ISO 18250-1 Medical devices — Connectors for reservoir delivery systems for healthcare applications
Part 1: Enteral applications General requirements and common test methods - ISO 18250-6 Medical devices — Connectors for reservoir delivery systems for healthcare applications
Part 6: Neural applications - ISO 18250-7 Medical devices — Connectors for reservoir delivery systems for healthcare applications
Part 7: Connectors for intravascular infusion - ISO 18250-8 Medical devices — Connectors for reservoir delivery systems for healthcare applications
Part 8: Citrate-based anticoagulant solution for apheresis applications
ANSI/AAMI CN27:2021 – Luer Activated Valves (LAVS)
Luer Activated Valves (LAVs) have been incorporated into medical devices for intravascular applications for several decades. As standards for small bore connectors were adopted, trends toward using a valve compatible with a standard fitting or syringe became more common. The concern, however, was that these LAVs were not standard luer connectors, primarily due to the challenge of incorporating a normally closed-valve design. As a result, manufacturers implemented their own controls to minimize connection risks.
The idea of developing a standard for needle-free connectors came about during the development of the ISO 80369 series of standards. A working group was then established to address this need and in 2021 ANSI/AAMI CN27:2021 was published. The standard establishes minimum general, performance, biological, chemical, and labeling requirements for LAVs, and is intended to assist manufacturers in the design and development of LAVs used in intravascular applications and to promote alignment in the use of common terminology and test methods.
Overview of ANSI/AAMI CN27:2021 Luer Activated Valves Testing
Contact us for more information or to talk to an engineer.
