ISO 80369 Small-Bore Connector Standard

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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 develop 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

THE “COMPLIANCE CLOCKS” ARE TICKING, ARE YOU READY?

ISO COMPLIANCE DEADLINE for NEW PRODUCT SUBMISSIONS
JAN. 1, 2020

ISO COMPLIANCE DEADLINE for EXISTING PRODUCTS
OCT 15, 2021

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

1st Quarter 2020

Priority Products Are Compliant

Priority Products Are Compliant

Merit’s priority products are available and compliant for customer’s submitting for regulatory clearance on new products

4th Quarter 2020

Compliance Testing Completed

Compliance Testing Completed

Merit completes all dimensional and functional testing on remaining product related to 80369-7

4th Quarter 2020

MERIT’S PRODUCTS ARE COMPLIANT

MERIT’S PRODUCTS ARE COMPLIANT

Merit has implemented the new ISO 80369-7 standard on all related 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:  Dimensional Requirements

    The description below is a basic overview of some of the dimensional requirements for ISO 80369-7 compared to the previous luer standard ISO 594. This information is discribing some of the changes Merit will be making 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 be reviewed and updated our male luers lock connection to include the tightened tolerances and dimensions 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.

    Compliant Product for New Products Submissions

    Merit is committed to being compliant to the ISO 80369-7 standard as soon as possible. Merit has been proactive to allocate the resources and the personnel needed to successfully understand, plan, and implement the requirements called out in the standard.

    The process of qualifying Merit’s products to the new standard is a project with multiple variables that may affect our compliance timeline. Merit OEM has identified some products as “priority” for our compliance project. These products will be compliant to ISO 80369-7 sooner than Merit’s full product catalog. These “priority products” have been selected to help customers needing 80369-7 compliant products for the “new product submission” deadline of Jan 1, 2020. The “priority products” include part numbers from the product groups below. To learn more about the specific part numbers included in the “priority products” list, please contact your Merit Medical OEM Sales Representative.  

    Compliant Product for Existing Products

    Merit is planning on reaching full compliance to 80369-7 by Dec. 31, 2020, which is well before the compliance deadline for existing products of October 15, 2021.

    Request additional information about ISO 80369-7 compliant product from Merit Medical OEM

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