ISO 80369 Small-Bore Connector Standard

Why is the luer standard changing?

“Actions must be taken at the patient bedside, within all levels of health care organizations and throughout the channels of regulation, manufacturing, and distribution of these devices in order to eradicate the serious problem of tubing misconnections.”

Peter B. Angood, M.D., Vice President & Chief Patient Safety Officer for The Joint Commission of the FDA.

FDA has participated in an international effort to develop and implement standards for non interchangeable connectors for small bore medical connections. The International Organization for Standardization (ISO) has developed a series of standards for incompatible connectors used in intravascular (IV), breathing systems, enteral, urethral/urinary, cuff inflation and neuraxial applications. Once implemented, ISO 80369 removes the ability to make inappropriate connections or misconnections in a clinical setting through non-compatible luer connection groups called out in ISO 80369.

ISO connections diagram

ISO 80369-7 Connectors for Intravascular or Hypodermic Applications

Since the publication of ISO 80369-7 in 2016, Merit has committed substantial resources towards planning and executing a proactive plan for compliance. Merit’s initial timeline for compliance was to transition all affected products to ISO 80369-7 by the end of 2020, ahead of the original October 2021 date recommended by the International Standards Organization. Merit also identified some products as “priority” with a sooner compliance timeline.  As Merit has aggressively pursued this compliance project, the current status of the standard has caused Merit to reevaluate the speed that we accomplish this project. Despite the changes to the status of ISO 80369-7:2016, Merit has successfully transitioned some of our priority products to be ISO 80369-7:2016 compliant.

Current Status of ISO 80369-7:2016

Second Edition of ISO 80369-7

Merit Medical has been in direct communication with ISO about the development of the second edition of ISO 80369-7. The second edition of ISO 80369-7 will replace ISO 80369-7:2016. The revisions include minor clarifications and potential changes to some dimensional tolerances that may change Merit’s path to compliance.

FDA Acceptance of ISO 594-1/-2 & ISO 80369-7:2016

In December 2019, the FDA removed the withdrawal date of ISO 594-1/-2, recognizing that the second edition of ISO 80369-7 was still being developed. Having removed this withdrawal date, the FDA announced the continued acceptance of ISO 594-1/-2 and ISO 80369-7:2016 as consensus standards. Once the second edition of ISO 80369-7 is published, the FDA will start a new transition period concluding with a new compliance deadline.   

EU Harmonizing ISO 80369

EN 20594 and EN 1707, the EU versions of ISO 594-1/-2, are harmonized to MDD. ISO 80369 is not harmonized to MDD, nor has a timeline been released for harmonizing ISO 80369 to MDR.

Merit’s Compliance Timeline

ISO 594 to ISO 80369-7

October 15, 2016

ISO 80369-7

ISO 80369-7

The new Intravascular or Hypodermic Standard is published

January 2017

Merit Forms Internal Team

Merit Forms Internal Team

Merit forms a team of engineerings and regulatory professionals to start this compliance project

January 2019

Dimensional Testing Equipment

Dimensional Testing Equipment

Merit obtains and qualifies new State-of-the-art VISION SYSTEM for dimensional testing requirements

February 2019

Modifications & Qualifications

Mold

Merit starts to modify and qualify molds to meet the specific design requirements in the standard

March 2019

Compliance Testing

Compliance Testing

Merit starts dimensional and functional testing on PRIORITY PRODUCTS

September 2019

Second Edition of ISO 80369-7

Second Edition of ISO 80369-7

The International Standards Organization starts development of second edition of ISO 80369-7, that will replace ISO 80369-7:2016.

4th Quarter 2019

FDA Acceptance of ISO 594-1/-2 & ISO 80369-7:2016

FDA Acceptance of ISO 594-1/-2 & ISO 80369-7:2016

FDA removes withdrawal date of ISO 594-1/-2 and announces the acceptance of ISO 594-1/-2 and ISO 80369-7:2016 as consensus standards until the second of ISO 80369-7 is published.

1st Quarter 2020

ISO 80369-7:2016 Compliant Products

ISO 80369-7:2016 Compliant Products

Merit certifys compliance to ISO 80369-7:2016 for some priority products. 

New with ISO 80369-7Merit’s Plan to Meet the New Requirements
Additional functional testing requirements regarding the elasticity of the materialThe new functional testing requirements regarding the luer connection material are being addressed for each resin type.
New Dimensional Requirements Include:

  • Separate test methods for functional and dimensional compliance
  • Testing with GAUGES IS NOT included in testing protocol
  • Specified depth to measure the taper
  • Two-sided tolerance
  • Outer diameter is called out in the standard
  • Dimensional testing will be performed by a new state-of-the-art VISION SYSTEM, purchased specifically to meet the stringent and rigorous testing protocol requirements of this standard.
  • Merit is also making mold modifications and redesigning products to meet the design requirements in the new standard.
Conditioning prior to functional and dimensional testing is requiredMerit will conduct dimensional and functional testing at T=0 and T=life of the product.
Inner lumens CANNOT EXCEED 8.3F or 0.114” and be compliant to 80369-7
  • Merit OEM offers a comprehensive line of valves, including valves with inner lumen smaller than 8.3F
  • Merit will not seek compliance on devices designed specifically with a LARGE BORE inner lumen.
  • New with IS0 80369-7 and Merit’s Plan to Meet the new Requirement

    New Requirement:

    • Additional functional testing requirements regarding the elasticity of the material

    Merit’s Plan:

    • The new functional testing requirements regarding the luer connection material are being addressed for each resin type.

    New Dimensional Requirements Include:

    • Separate test methods for functional and dimensional compliance
    • Testing with gauges IS NOT included in testing protocol
    • Specific depth to measure the taper
    • Two-sided tolerance
    • Outer diameter is called out in the standard

    Merit’s Plan:

    • Dimensional testing will be performed by a new state-of-the-art VISION SYSTEM, purchased specifically to meet the stringent and rigorous testing protocol requirements of this standard.
    • Merit will make mold modifications for product needing design changes to meet the new dimensional requirements.

    New Requirement:

    • Conditioning prior to functional and dimensional testing is required

    Merit’s Plan:

    • Merit will conduct dimensional and functional testing at T=0 and T=life of the product.

    New Requirement:

    • Inner lumens CANNOT exceed 8.3F or 0.114” and be compliant to 80369-7

    Merit’s Plan:

    • Merit OEM offers a comprehensive line of valves, including valves with inner lumen size smaller than 8.3F.
    • Merit will not seek compliance on devices designed specifically with a LARGE BORE inner lumen.

    ISO 594 to ISO 80369-7:2016

    The description below is a basic overview of some dimensional requirements for ISO 80369-7 compared to the previous luer standard ISO 594. This information is describing some changes Merit will make to our luer connection to become compliant. For a full description of this new standard Merit recommends visiting the ISO website. https://www.iso.org/standard/58011.html

    In general, Merit will review and update our male luer lock connection to include the tightened tolerances and dimensional requirements specified in the standard. Here are some examples of those updates and requirements.

    Dimension Table ISO 80369-7

    Some of Merit’s products feature a male luer designed with a chamfer to the inner dimension of the luer as shown below. This chamfer will be removed to allow the affected components to be compliant to 80369-7.

    Dimension Table ISO 80369-7

    A number of Merit’s female luer lock connections were originally designed with a ANSI style thread, that will be modified to the new ISO 80369-7 style thread as shown below.

    Working Towards Compliance

    Despite the current status of ISO 80369-7, Merit continues to work on transitioning more of our priority products to be ISO 80369-7:2016 compliant.

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