Understanding Medical Device Shelf-Life Testing with ASTM F1980

Have you ever wondered how medical devices, from surgical tools to life-saving implants, stay safe and effective even after months or years in storage? This is where medical device shelf-life testing comes into play. Shelf-life testing, defined by the ASTM F1980 standard, is a vital process that helps manufacturers determine how long a device can be stored before it degrades, ensuring that the product is safe, effective, and compliant with industry standards throughout its entire lifecycle. Let’s explore how this testing process works and why it’s crucial for the healthcare industry.

Medical Device Shelf-Life Testing & Its Benefits

When package testing experts perform medical device shelf-life testing, they use a method for accelerated aging under repeated temperature exposure. This method simulates the effects of real-time aging on medical devices under extreme temperatures and humidity levels. How rapidly the sterile barrier breaks down helps determine the product’s safety, durability, and stability.

The following medical devices are subject to shelf-life testing:

  • Orthopedic implants like hip and knee replacements or bone screws and plates
  • Cardiovascular implants, including pacemakers and heart valves
  • Surgical instruments like scalpels, forceps, retractors, and endoscopes
  • Sterile disposables, including syringes, catheters, and surgical gloves
  • Diagnostic devices, including pregnancy test kits or urinalysis strips
  • Dental devices, like dental implants, orthodontic applicants, or dental crowns.
  • Drug delivery systems, including Inhalers and prefilled syringes

Because all of the above medical devices are inserted directly into the body, maintaining sterility is of the utmost importance. If a device’s packaging degrades or the materials themselves break down over time, it may no longer be fit for use and could result in costly recalls.

In addition to patient safety, medical device shelf-life testing is a key requirement for meeting industry regulations and standards. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global authorities require manufacturers to provide evidence of a device’s durability, performance, and sterility over time.

Finally, a device that maintains its functionality and sterility over an extended period is more attractive to healthcare providers, who need to trust that the products they use will perform as expected. For manufacturers, this can be a significant competitive advantage.

Accelerated Aging vs. Real-Time Shelf-Life Testing

When testing the longevity and durability of medical devices, there are two primary approaches: accelerated aging and real-time aging.

Accelerated aging, as outlined in ASTM F1980, is a method used to speed up the aging process of a medical device by exposing it to elevated temperatures and controlled environmental conditions. Manufacturers can simulate the effects of years of real-time aging in just a matter of weeks or months. This method allows manufacturers to meet tight production timelines and bring products to market faster.

Real-time aging involves storing the medical device under normal conditions for the actual length of its intended shelf life. If a device is meant to last for five years, it’s stored and monitored for five years. This method provides the most accurate representation of how a device will perform at the end of its shelf life, ensuring that it maintains sterility, integrity, and functionality throughout its lifecycle.

At Purple Diamond, we can perform both methods of medical device shelf-life testing and will work with you to determine which method will be most advantageous for your unique product and needs.

Accelerated Medical Device Shelf-Life Testing: The Process

Medical device shelf-life testing involves several key steps, each designed to evaluate how well a product will withstand the effects of time, environmental conditions, and storage.

  1. Defining Test Requirements: These requirements are typically based on the device’s materials, packaging, and intended shelf life.
  2. Setting Up Conditions: The medical device is placed in an environmental chamber where conditions such as elevated temperatures are applied to simulate the effects of long-term storage.
  3. Post-Aging Evaluation: Various tests will assess whether the device has maintained sterility and whether any materials have degraded or weakened. These tests may include seal integrity, burst, or peel testing.
  4. Documentation & Reporting: After testing, the results and any observations must be documented in detail. The testing reports should indicate how well the medical device performed under the conditions and whether it meets the necessary regulatory and safety standards.

It is important to note that manufacturers may need to repeat the testing process if the device’s design, materials, or packaging change.

Uncover Expertise in Shelf-Life Testing

At Purple Diamond, we understand that medical device shelf-life testing is not just about meeting regulatory requirements—it’s about ensuring patient safety, maintaining product integrity, and building trust with healthcare providers. We’ll help your medical devices meet regulatory standards and withstand the test of time. By partnering with us, you can confidently navigate the complexities of shelf-life testing and ensure your devices maintain their safety and effectiveness throughout their entire lifecycle.

Ready to get started? Contact us today for a consultation or a quote, and we’ll help you get your medical device to market safely and effectively.

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