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What You Need to Know About the Updated ISO 80369-20 Standard

The latest revision of ISO 80369-20:2024 introduces critical updates to standardized test methods, shaping the design and evaluation of small-bore connectors. These connectors are essential in healthcare, ensuring the safe and efficient delivery of fluids, gases, and medications. As part of the ISO 80369 series, this standard continues to set the global benchmark for defining connector types and functions across a wide range of applications, including intravenous, enteral, and neuraxial systems.

ISO 80369-20:2024 introduces several key updates including:

  1. Terminology Modernization
    The terms “male” and “female” have been replaced with “cone” and “socket” to standardize language and to help promote more inclusive and standardized terminology across industries.
  2. Expanded Applicability
    The standard now includes connectors specified in the ISO 18250 series, covering reservoir delivery systems across various medical applications, which enhances compatibility and safety across applications such as respiratory, enteral, neural, intravascular, irrigation, and citrate-based anticoagulant systems.
  3. Refined Disconnection Test (Annex I)
    The method for testing disconnection by unscrewing has evolved. Instead of a fixed torque rate of 2 r/min, the test now uses an Increasing Unscrewing Torque approach, measuring the Peak Torque at which the connector begins to loosen.
  4. New Test for Air Leakage During Aspiration
    Annex K introduces a test method that evaluates the integrity of the connector by applying subatmospheric pressure while the sample is fluidized allowing for the visual detection of air bubbles.
  5. Environmental Test Conditions
    The relative humidity range has been expanded from 25–65% RH to 10–70% RH to accommodate materials, such as hygroscopic materials, that are sensitive to moisture.
  6. Enhanced Reporting Requirements
    Manufacturers are now required to provide detailed test reports, including testing dates, number of connectors used, preconditioning and environmental conditions, deviations from test methods, and any unusual observations.

These updates aim to improve the clarity, applicability, and comprehensiveness of the standard, ensuring safer and more effective use of small-bore connectors in healthcare settings. These changes do not require retesting if your device / luer component was tested against previous ISO 80369-20 versions. These changes only apply to new regulatory device submissions and applications.

Please contact us for more information on ISO 80369 testing or if you need help on an upcoming test.

ISO 11040-4:2024 – Key Updates You Need to Know

The release of ISO 11040-4:2024 marks a significant evolution in the standards for prefilled syringes, replacing ISO 11040-4:2015. This new edition brings crucial updates that align with the latest industry practices and provide improved clarity across the standard by reformatting and numbering various sections. In this blog, we’ll dive into the most important updates introduced in ISO 11040-4:2024.

1. Enhanced Quality Systems, Testing, and Documentation

One of the standout updates in ISO 11040-4:2024 is the heightened focus on adhering to formal Quality Management Systems (QMS). 

Key changes include:

  • All documentation and testing processes must now comply with a formal QMS.
  • Test equipment used in syringe production must be qualified to guarantee accuracy and consistency.
  • Test methods must be validated to ensure they are appropriate for their intended purpose.
  • Electronic records and handwritten signatures related to validation, process control, or quality decisions must be meticulously documented and retained in line with QMS standards.

These updates aim to foster greater consistency and transparency throughout the production and testing process, ensuring a higher level of control over quality and traceability.

2. New Design Requirements for Staked Needle Syringes

Another major revision in ISO 11040-4:2024 involves the specific requirements for staked needle syringes, which are commonly used in prefilled syringe applications. These updates focus on ensuring clear communication and alignment between manufacturers and clients.

The new guidelines include:

  • Agreement on the needle diameter and length as well as the finger flange design between both manufacturer and client.
  • A new tolerance table has been introduced, covering different syringe volumes and needle lengths for better standardization.
  • Updated figures depicting typical staked needle syringe designs to provide clearer visual guidance.

These changes are intended to improve collaboration between stakeholders, reducing design misalignment and ensuring higher quality syringe outcomes.

3. Updated Performance Standards for Syringe Components

ISO 11040-4:2024 introduces new performance metrics for syringe components, particularly related to breakage resistance and needle penetration force.

Notable updates include:

  • Defined minimum force requirements for both finger flange breakage resistance and front end breakage resistance (formerly Luer cone breakage resistance) to prevent syringes from breaking during handling or transport.
  • A new maximum penetration force for needles has been specified to detect defects in needle points or lubrication that could impact patient comfort.

These updated performance standards ensure that syringes can withstand rigorous use, minimizing the risk of failure and improving patient experience.

4. Expanded Glide Force Test for Non-Lubricated Syringes

Previously, the Glide Force Test Method was only applicable to lubricated syringes. However, ISO 11040-4:2024 now extends these guidelines to cover non-lubricated syringes, which are becoming more prevalent.

This extension allows manufacturers to perform more comprehensive performance assessments, ensuring that non-lubricated syringes meet the same quality benchmarks as their lubricated counterparts.

5. Updated Figures for Better Technical and Visual Clarity

To enhance understanding and implementation, the figures throughout ISO 11040-4:2024 have been named and numbered to clearly outline the requirements of each section. These updates offer clearer, more accurate depictions of syringe components and designs, making it easier for manufacturers and quality teams to interpret and apply the standard.

This refinement helps reduce ambiguity and improves technical clarity, which is vital for compliance and product quality.

6. Revised Annex B for Sub-Assembled Syringes

Finally, Annex B has been updated to include additional details about sub-assembled syringes that are ready for filling. This now covers examples of plunger stopper variants and plunger rods, adding to the previous edition’s focus on head designs for glass barrels.

These revisions offer clearer guidance on the components of sub-assembled syringes, providing manufacturers with better insights into the assembly process before filling, which is crucial for ensuring product consistency.

Conclusion

The release of ISO 11040-4:2024 introduces vital updates across quality management, syringe design, performance testing, and sub-assembly guidelines. For manufacturers and quality assurance professionals, staying informed about these changes is critical to maintaining compliance and delivering high-quality products.

Please contact us for more information on ISO11040 testing, or if you need help on an upcoming test.

ANSI/AAMI CN27:2021: A New Benchmark for Luer Activated Valves in Medical Devices

The field of medical device manufacturing continually evolves to enhance patient safety and device reliability. One key development in this area is the publication of ANSI/AAMI CN27:2021, a comprehensive standard that establishes general requirements for Luer Activated Valves (LAVs) used in intravascular applications. Published in December 2021, this standard is essential for harmonizing terminology, setting minimum requirements, and standardizing test methods for LAVs. It serves as the first foundational guide for manufacturers, regulatory bodies, and end users, offering clarity and consistency in the evaluation of these critical components.

The History and Challenges of Luer Activated Valves

Luer Activated Valves have long been integral to medical devices, especially in intravascular applications. Originally developed as needle-free connectors, they are now used in a variety of medical scenarios such as IV access, hemodialysis and close medication delivery systems. The shift towards using a valve compatible with standard fittings or syringes emerged as a response to the need for safer and more efficient, bi-directional fluid control systems. However, these LAVs presented unique challenges as the incorporation of a normally closed-valve design within an ISO-compliant luer distinguished them from the standard luer connectors.

Although there was guidance from ISO 80369-7 on how to evaluate that LAVs were compatible with standard male luer connectors, manufacturers adopted their own specifications to manage the complexities and risks associated with LAV connections. Furthermore, the variety of applications in how the LAV was used led to different product descriptions, performance claims, and instructions for use. As a result, this unfortunately caused confusion among end users which required manufacturers to educate the field on device capabilities and interactions.

Testing LAVs Prior to the Development of ANSI/AAMI CN27

Prior to the standardization of LAVs, testing was primarily conducted per the guidance of Annex A of ISO 80369-7. Within DDL, we have seen that there were two main approaches to showing LAV compatibility. The first approach was to conduct functional testing in guidance against the applicable ISO 80369-7 standard using the mating reference connector outlined in Annex C of ISO 80369-7. The second approach was similar but would involve the mating device (e.g. male luer lock syringe) as the reference connector to show compatibility. In addition, to the performance testing, a majority of our customers conducted the physical test method under ISO 80369-1 to show non-interconnectability characteristics rather than analyzing the specified dimensions from ISO 80369-7, Annex B.

Unfortunately, there were several issues with the guidance that ISO 80369-7 standard provided and the approaches above. As the standard mentions, most LAVs in the field were not compliant to the material requirement (i.e. Elastic/Flexural Modulus ≥ 700 MPa). As a result, conducting ISO 80369-1, Annex B non-interconnectability testing posed challenges if the material was soft as damage could be seen after one run of testing against an ISO 80369 metal reference connector. If the LAV was damaged and connected to the reference connector, it was difficult to determine if the damage caused the connection or if it was due to the design. In addition, the guidance did not account for other critical characteristics of the LAVs such as flow rate, priming/residual volume, and the performance while the valve was unactivated. For example, the performance testing outlined in ISO 80369-7 only challenged the LAV in the activated condition, but did not challenge the device in the unactivated condition to show that the valve was sealing properly. The ambiguity in how to properly characterize these critical elements of the LAVs to show patient safety highlighted the need for a standardized approach.

Key Features of ANSI/AAMI CN27:2021

1. Standardized Terminology and Requirements:
ANSI/AAMI CN27:2021 addresses the inconsistencies that previously existed in the market by standardizing the terminology and requirements for LAVs. This standardization includes precise definitions for terms like microbial ingress, activation number and duration, displacement, and power infusion capabilities. The uniformity in language helps ensure that all stakeholders, from manufacturers to regulators, have a clear and consistent understanding of device specifications.

2. Impact of Terminology on Performance Claims:
The standard recognizes the importance of precise language in regulatory and clinical contexts. For instance, due to the bi-directional nature of the device, the definition of fluid movement as “positive” or “negative” displacement affects how a device’s performance is communicated and understood by the end user. Such clarity allows manufacturers to better identify their device’s performance in order to make accurate, comparable performance claims on these devices now. The comparable performance claims not only promotes competition between manufacturers, but it also allows the end users to objectively determine which devices to use for their patients.

3. Harmonized Test Methods:
One of the critical contributions of ANSI/AAMI CN27:2021 is the harmonization of test methods. By establishing uniform test procedures, the standard enables reliable comparisons of performance claims among different LAV products. This is particularly crucial for making performance claims where consistent testing ensures accurate and meaningful labels. Although the standard outlines a uniform test procedure, there are some areas where testing will differ based on the specific application of the product. For example, manufacturers will still be responsible for understanding the longest intended use period and the number of intended activations/de-activations. Even with different applications, the harmonization of test methods allows manufacturers to mitigate subjective performance data, misleading claims and unintended clinical consequences.

Benefits for Manufacturers, Regulatory Agencies, and End Users

ANSI/AAMI CN27:2021 provides a comprehensive framework that benefits all stakeholders involved with LAVs. For manufacturers, the standard offers clear guidelines for designing and developing compliant devices, facilitating smoother interactions with regulatory agencies. Furthermore, due to the standardization of LAVs, manufacturers no longer have to conduct compatibility testing against specific mating devices to show functional compliance. Regulators, in turn, gain a robust tool for evaluating product safety and efficacy based on standardized criteria. End users, including healthcare professionals, benefit from consistent and reliable product information, reducing confusion and enhancing the safe use of LAVs.

Conclusion

The publication of ANSI/AAMI CN27:2021 marks a significant milestone in the standardization of Luer Activated Valves for medical devices. By establishing clear guidelines and harmonizing terminology and test methods, this standard provides a valuable resource for ensuring the quality and safety of LAVs used in intravascular applications. As the medical device industry continues to advance, adherence to ANSI/AAMI CN27 will be crucial in maintaining high standards of patient care and device performance.

For those involved in the design, regulation, or use of LAVs, understanding and implementing the requirements set forth in ANSI/AAMI CN27:2021 is essential for aligning with industry best practices and ensuring the safety of patients around the world.

For further information, please view the recent video with Matt Pasma, DDL’s Product & Materials Program Manager, in which he provides an overview of DDL’s Luer Activated Valve (LAVs) testing capabilities per the ANSI/AAMI CN27:2021 standard. 

Please contact us for more information on LAVs testing, or if you need help on an upcoming test.

Overview of Updated ASTM F88/F88M – 23

ASTM F88/88M, the standard test method for assessing the seal strength of flexible barrier materials was recently updated.  

In previous revisions, Techniques A, B, and C in the standard offered clear testing instructions for flexible-to-flexible or semi-rigid packages (such as pouches), but it lacked clear guidance on conducting tests for trays made of flexible-to-rigid or semi-rigid materials.

The latest revision ASTM F88/F88M-23 has rectified this gap by providing users with guidance on conducting seal strength testing for trays. Two approaches relevant to trays have been incorporated into Technique C, offering users options to determine the most suitable method for testing their packages.

For further detail on this update, please see our recent video with DDL’s Lab Supervisor Kevin Rardon demonstrating Technique C performed on trays, along with Technique A and Technique C with pouches.

DDL has extensive experience conducting seal strength testing on trays. Historically, our approach involved following the flexible-to-intact rigid or semi-rigid structure method, and this approach will remain consistent in our future testing procedures.

Furthermore, we have carried out Test Method Validation (TMV) across all DDL locations based on this approach. This validation process further ensures the reliability and consistency of our testing method, providing added confidence in its repeatability and reproducibility.

In addition to the changes on the testing of trays, the new revision also provided updated information on:

  • Flexible to flexible ILS background, rationale, and analysis  in Appendix X1
  • Flexible to Rigid ILS background, rational, and analysis in Appendix X2
  • Impact of variation in sample width and separation speed in Appendix X3
  • Optional test fixtures in Appendix X4

Please contact us for more information on Seal Strength testing or if you need help on an upcoming test.

ASTM D4169-23e1 Unpacking the Changes

This revision brings about changes primarily to compression testing, and the definition of small and lightweight packages and when to use height stack values. In this blog post, we will examine the key modifications introduced in the latest revision.

Clarification in Section 3
One of the notable changes outlined in Section 3, specifically in Sub-section 3.2.7, where a new definition for “Small and Lightweight Package” is introduced. This definition, encompassing packages weighing under 10 lbs (4.53 kgs) with a volume below 2.0 ft³ (0.056 m³), aims to provide guidance when determining the maximum stack height (H) factor. Section 3.2.7 was intended to replace Note 3 in ASTM D4169-22.

Update: Paragraph two of Section 11.4.2 was intended to replace Note 3 in section 11.4 of ASTM D4169-22. However, Note 3 was inadvertently left in the ASTM D4169-23 publication, which has led to user confusion. This change along with several other minor editorial changes were identified during a subsequent review and have been rectified in the publication of ASTM D4169-23e1, which was released on March 27, 2024.

Conditioning Standards Enhancement in Section 6
The entire ASTM D4169-23e1 standard sees an added reference to ASTM F2825 – Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery. Under Section 6 Conditioning, this reference suggests that when testing is conducted using DC-13, the F2825 environmental conditioning may also be applicable, particularly for expedited shipments. This addition acknowledges the importance of testing under conditions that reflect real-world temperature variations, providing a more realistic assessment of packaging system performance.

Streamlining Warehouse and Vehicle Stacking in Section 11
Section 11 includes notable changes in Schedule B (Warehouse Stacking) and Schedule C (Vehicle Stacking). Type 4 for Shipping Unit Construction has been removed for redundancy. The introduction of a Shipping Density Factor (Mf) range, along with an increased default value, directly impacts the theoretical target load force applied to packages during compression.

Noteworthy changes in 11.4.1 suggest varying shipping density factors for mixed load and LTL shipments. The implications of these changes can be observed in real-world examples, highlighting how the revised standard can lead to higher vehicle stacking top loads.

Section 11.4.2 was added to clarify when the user may consider reducing H from the recommended default height of 108 inches. FIG. 2 Maximum Stack Height (H) Decision Matrix should be used to determine that height. Paragraph two of Section 11.4.2 was also intended to replace a portion of Note 3 in ASTM D4169-22 (see above).

Enhancements in Section 12 – Stacked Vibration
Section 12, specifically Schedule D – Stacked Vibration, contains an update in the recommended shipping density (M), increasing it from 10 to 12. This adjustment aligns with the industry’s continuous pursuit of ensuring packaging resilience in diverse environmental conditions.

If you have any questions about the recently updated ASTM D4169 standard, or need help with an upcoming test, please don’t hesitate to contact us, or call us at 800-229-4235.

ASTM F1929 Dye Penetration Integrity Test

ASTM F1929 “Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration” is a dye penetration package integrity test used by package engineers that is designed to detect and locate leaks caused by channels formed between a transparent film and a porous material.

The ASTM F1929 standard was first written in 1998, was reapproved in 2004, and then ASTM made a significant update to it in 2012. In 2015, the standard was updated with no significant changes. The standard was recently updated in December of 2023. The notable change in the newly revised standard is the allowed use of alternative surfactants other than Triton X-100 as the surfactant component in the dye solution.

DDL still receives many questions about ASTM F1929. Here is a quick overview of the changes over the years:

ASTM F1929-98 (2004)

  • Utilized injection method. Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal.
  • Observe each seal for a recommended duration of 5 to 20 seconds.

ASTM F1929-12  

  • Three test methods are now called out:
    • Test Method A: Injection method (same method used from previous ASTM F1929-98 (2004). Inject dye solution within the sealed package and observe for leaks, originating from the inside edge of the package seal towards/through the outside edge of the package seal.
    • Test Method B: Edge dip method. Dip the outer edge of the package seal evenly within the dye solution and observe for leaks, originating from the ouside edge of the package seal towards/through the inside edge of the package seal.
    • Test Method C: Eyedropper method. Note: The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal. Along the extended unsealed area (beyond outer seal edge), the transparent material is separated from the porous material (with use of a finger, paperclip, etc.). Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area. Place a bead of solution between the two materials along the outer edge of the package seal, ensuring the entire outer edge of the seal is wetted with the dye solution. The package is then observed for leak,originating from the outside edge of the package seal towards/through the inside edge of the package seal.
  • As a guide, each Test Method above recommends observing each seal for a maximum of 5 seconds on a 4-sided package (20 seconds total).
  • If a channel is present in the seal, the location should be accentuated by the wicking of the porous substrate/material around the channel.

ASTM F1929-15

  • No significant changes.

ASTM F1929-23

  • The use of alternative surfactants other than Triton X-100 as the surfactant component in the dye solution is now allowed. These alternatives must adhere to the specified requirements:
    • The surfactant should be nonionic.
    • The chemical properties should align with a surface tension ranging from 30 mN/m to 33 mN/m, a hydrophilic/lipophilic balance (HLB) exceeding 10, and a critical micelle concentration (cmc) below 2000 ppm.

The ASTM F1929 is currently a recognized consensus standard by the FDA. Please keep this in mind when developing your studies and validations.

Please contact us with any questions you may have about ASTM F1929, or if we can help you with any other testing questions or projects.

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