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A Summary of the Updated ISO 80369-7 Standard

In May, 2021, ISO published the updated 80369-7 standard. ISO first published ISO 80369 Part 7 in October, 2016 as the replacement to ISO 594, the standard governing dimensions and performance requirements of Luer connectors.

Following are some of the highlights of the updated 80369-7:2021 standard:

General

  • Two different categories for material’s modulus of elasticity:
    • Semi-Rigid (700 MPa to 3,433 MPa)
    • Rigid (Greater than 3,433 MPa)
  • Remove the need to ASTM D638 and ASTM D790 in the luer testing. The standard now leans on the requirements of ISO 80369-1:2018 for this part of testing.
  • Update references to the new versions of standards, Specifically ISO 80369-1:2018

Performance Testing

  • Unscrewing torque range has been revised to 0.018 – 0.020 N·m

Dimensional Testing

  • The tolerances for specific dimensions across Annex B have been updated based on the type of material (semi-rigid or rigid) used to manufacture parts
  • Some dimensions are now considered to be auxiliary
  • Some tolerances were loosened to make it easier to manufacture the parts.

Reference Connectors

  • The dimensional tolerances have loosened, easier to calibrate and manufacture
    • Note: this does not affect DDL’s calibrated reference connectors

Starting with the publication of ISO 80369-7 in October 2016, the FDA gave manufacturers a three-year grace period to show that parts previously compliant with ISO 594 are now compliant with ISO 80369. Originally the FDA stated it would no longer accept submissions showing conformance to ISO 594 after December 31, 2019. The FDA has since extended the deadline to December 17th, 2023.

The European Union’s joint technical committee is working with ISO on the development of the ISO 80369 series of standards to ensure requirements from the EU directives are met and the standards can be accepted by the EU. Currently the EU has withdrawn the previous versions of the Luer testing standards and as of May 31, 2020 they will no longer accept submissions to the previous versions of the standards.

Once updates are completed to a standard, the EU will give one year before withdrawing the previous version of the standard and requiring compliance with the currently accepted version of a standard.

For more information on ISO 80369-7, please download our white papers “ISO 80369-7: Changing the Standard for Luer Connectors” or “ISO 80369 FAQs”.

Please contact us if you have further questions or need help with an upcoming test project.

DDL Expands its Minnesota Testing Laboratory Operations

DDL announced it has significantly expanded its capacity and capabilities for medical device, materials and package testing at its Eden Prairie, MN laboratory to better serve its customers.

The 15,000 square foot expansion of DDL’s MN laboratory facility includes:

  • A new 3,000 square foot environmentally controlled lab (23C +/-2C and 50% +/-5% RH)
  • Nine Instron machines, including three new machines: 68TM-50kN, 68SC-1kN with torsion, and ElectroPuls E3000 with torsion for dynamic fatigue testing
  • The latest software upgrades on all Instron machines, including traceability for 21 CFR Part 11 compliance.
  • A new backup generator
  • Seven new chambers, adding over 5,000 cubic feet of additional chamber capacity to DDL’s 25,000 square feet of environmental conditioning capacity in its MN location.
  • A new shock test system that accurately measures the fragility of products and evaluates how they respond to specific shock inputs. Shock test data is key information when determining if your product is capable of withstanding its intended distribution and use environment.
  • A new training center for both internal and external purposes.

“This expansion in our Minnesota laboratory gives us even more capacity to conduct packaging, medical device and material testing for our customers,” said Tamera Presler, General Manager, DDL. “This additional capacity and expanded capabilities also allows us to provide faster turnaround for our medical device and pharmaceutical customers, which helps reduce development lead time and shorten product time-to-market.”

Please contact us for more information or call 800-229-4235 if you would like to speak with one of our testing experts.

DDL Enhances its Medical Device and Pharmaceutical Testing Capabilities to Support the Fight Against COVID-19

DDL is now offering testing for medical products such as ventilator components, masks, gloves and gowns used on the frontlines in the fight against COVID-19. In addition, DDL offers testing services to support the development of COVID-19 vaccines and therapeutics.

DDL’s testing services for COVID-19 related medical products include:

  • Testing of connectors and hosing for ventilators – ISO 5356-1, ISO 5359 and ISO 18082
  • Performance of materials for medical face masks – ASTM F2100 and EN14683
  • Tensile, bursting strength and liquid penetration tests on medical gowns – ASTM F1868, ASTM D751, ASTM D1683, ASTM D1776, ASTM D5034, ASTM D5587, and ASTM D6701
  • Safety testing and degradation tests on medical gloves – ASTM D3578, ASTM D5250, ASTM D6319, and ASTM D6977

DDL also provides the following testing services to support its biopharmaceutical customers developing COVID-19 vaccines and therapeutics:

“DDL has maintained business continuity to support our customers that develop and manufacture life-saving medical supplies and technologies as we respond to this global pandemic,” said Tamera Presler, General Manager, DDL, Inc. “Our employees have been fully trained on essential preventative measures. We remain committed to providing our customers with fast, accurate, and high quality testing during these unique and challenging times to ensure the safety and well-being of all.”

For more information on these tests, or to receive a quote, please contact us or call us at 800-229-4235.

DDL Now Offering Medical Device Testing at its Irvine, California Laboratory

DDL is now offering select medical device testing at its DDL West laboratory located in Irvine, CA. Testing of catheters, Luers, needles, syringes, guidewires and IV infusion sets is now available at this location. Previously, testing of these products was only available at DDL’s headquarters in Eden Prairie, MN.

The DDL West laboratory recently relocated from Fountain Valley, CA to Irvine, CA. The new facility more than doubles the lab space, which will increase DDL’s testing capacity and ability to grow to better meet its customers’ testing needs. The medical device testing being added is in addition to the package testing (ISO 11607) and ICH stability testing already being offered in this lab facility. Full product, materials and package testing capabilities continue to be offered at DDL’s headquarters.

“The addition of medical device testing to DDL West reflects our commitment to offering our customers the best testing experience possible,” said Corey Hensel, General Manager, DDL. “Having these additional testing services will allow us to provide faster turnaround and reduce development lead time and shorten product time-to-market for our medical device and pharmaceutical customers located in California and the surrounding region.”

The testing being added to DDL’s CA lab will utilize the following standards:

  •     ISO 80369-6 – Medical connectors for neuraxial applications
  •     ISO 80369-7 – Medical connectors for intravascular or hypodermic applications
  •     ISO 10555 – Sterile and single-use catheters
  •     ISO 9626 – Stainless steel needle tubing
  •     ISO 7886 – Hypodermic syringe testing
  •     ISO 8536 – Intravenous infusion set and accessory testing
  •     ISO 11070 – Introducer and guidewire testing

For more information on these tests, or to receive a quote, please contact us or call 800-229-4235.

DDL Now Offering ISO 11608-1 Testing for Needle-Based Auto Injection Systems

DDL, Inc. announced today it is now offering testing based on ISO 11608-1, the governing standard that specifies general requirements and test methods for needle-based injection systems. These new capabilities supplement DDL’s already extensive expertise in syringe, needle and combination product testing.

“Many new drugs and biologics coming to market today are well suited for administration via needle-based injection systems or auto injectors,” said Levi Loesch, Product and Materials Engineer, DDL, Inc. “DDL is now able to perform the testing as defined in ISO 11608-1 to ensure these devices meet the dose accuracy requirements.”

ISO 11608 is comprised of seven parts. DDL currently provides testing for ISO 11608-1 – needle-based injection systems intended to be used with needles and with replaceable or non-replaceable containers. DDL is actively working to add additional parts of the 11608 standard to its list of core tests.

 Please contact us for more information on DDL’s ISO 11608 testing capabilities.

ISO 80369-7: Changing the Standard for Luer Connectors

On October 14, 2016 ISO formally published 80369 Part 7, the long-awaited replacement to everyone’s familiar friend, ISO 594, the standard governing dimensions and performance requirements of Luer connectors. The publication caps a monumental change in the fundamental thinking surrounding devices that transfer liquids and gases in healthcare settings. Despite the Technical Committee’s desire to disrupt as little as possible surrounding the current practices with Luer connectors, ISO 80369-7 still makes many significant changes.

As should be expected with changes of this magnitude, there are many nuances in the new standard that require some interpretation. At DDL, we have had the opportunity to work with members of the ISO Technical Committee and many industry partners to interpret these changes.

In a new white paper, DDL’s Product and Materials Engineer Levi Loesch highlights the changes that most significantly affect how one should construct their design verification plan. Levi discusses the following points in the white paper:

  • stricter requirements on dimensional and mechanical specifications,
  • testing against slip and lock reference connectors,
  • modifications to assembly and test procedures, and
  • addition of guidance for performance of variable tests.

Update: On December 23rd, 2016, the FDA added ISO 80369-7 to its list of recognized consensus standards. The FDA originally stated it would stop accepting conformity to ISO 594 in support of pre-market submissions on December 31st, 2019. However, this deadline has been extended, and a new deadline has not yet been announced. DDL will continue to offer testing to both ISO 594 and 80369 to meet the needs of our customers until then.

It should also be noted this white paper is intended to give a high-level overview of the differences between ISO 594 and 80369-7 and is not intended to be a substitute for a comprehensive understanding of the contents of the standards. We at DDL always welcome an opportunity to discuss the nuances of the standards in greater detail, so please don’t hesitate to contact us if you have any lingering questions or would like to discuss an upcoming project.

Please click here to download a copy of the new white paper.

Please contact us today for more information on ISO 80369 ISO testing.

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