Real-time and accelerated aging testing for medical devices

What is real-time aging testing?

Real‑time aging medical device studies evaluate how a device ages under normal storage conditions over its full intended shelf life. Unlike accelerated aging, this method does not simulate time—it measures it exactly as it passes.

Real‑time aging of medical devices provides definitive, regulatory‑accepted evidence to confirm that the results of accelerated aging are accurate and representative of real storage conditions. Manufacturers rely on medical device real‑time aging to validate shelf-life claims, verify packaging integrity, and ensure ongoing device safety and performance.

Real‑time testing is mandatory in many regulatory pathways and is often performed in parallel with accelerated studies to support faster market access while maintaining long‑term scientific assurance. 

What is acceleratedaging testing?

Accelerated aging testing for medical devices is a laboratory process used to simulate the natural passage of time by exposing a device and its packaging to elevated temperatures and controlled humidity conditions. This technique speeds up the degradation mechanisms that occur during normal storage, enabling manufacturers to estimate a device’s shelf life much faster than real time.

This method is widely used to support accelerated shelf life testing for medical devices, accelerated aging testing medical devices, and validation activities required for regulatory submissions. Accelerated aging is particularly important for sterile medical device packaging, with many studies performed according to ASTM F1980 accelerated aging medical device packaging guidelines. The goal is to ensure that devices maintain safety, performance, and packaging integrity throughout their intended shelf life while reducing the time needed to generate expiry date data.

Why is real-time and accelerated aging testing important?

Alongside accelerated studies, real-time ageing tests are mandatory to confirm the results obtained from the accelerated process, ensuring the expiry dates claimed by manufacturers are accurate and reliable. These tests are fundamental for regulatory compliance, such as for FDA 510k pre-market notification in the United States and CE marking (MDR 2017/745) in Europe, using methodologies following standards such as ASTM F1980.

What real-time and accelerated aging do we perform?

At Applus+ Laboratories, we conduct comprehensive real-time and accelerated ageing tests to validate the claimed shelf life of your products. Our services are designed to meet the stringent requirements of standards such as ISO 11607-1, the primary document for validating sterile barrier systems.

Our testing process includes:

• Parameter Validation: We begin by validating the appropriate ageing parameters, primarily temperature and humidity, ensuring they are as high as possible to shorten test duration without damaging the packaging or the device itself.
• Controlled Environment Testing: Tests are performed in state-of-the-art climatic chambers equipped with metrological monitoring, ensuring continuous and precise control of temperature and humidity throughout the study.
• Visual Inspections: We conduct thorough visual inspections of the packaging before, during (through intermediate sample extraction), and after the ageing process.
• Integrity Validation: Our studies allow for intermediate samples of sterile packaging to be taken, enabling the assessment of packaging integrity at various ageing points within a single study.
• Functional Checks: While our primary mission is to inspect sterile packaging, clients can also retrieve their medical devices post-ageing to perform functional checks and validate device performance.
• Monitoring: We perform daily monitoring of temperature and % RH.
• Detailed Reporting: Our experts provide systematic technical feedback and detailed reports to the customer.

We also offer a comparison with natural ageing (conducted at 23°C / 50% RH) to provide a comprehensive understanding of product stability. All tests are carried out under our ISO 17025 accreditation (COFRAC).

Accelerated aging factor (AAF) and arrhenius equation 

The Accelerated Aging Factor (AAF) is calculated using the Arrhenius equation, which models how elevated temperatures accelerate chemical and physical degradation. This scientific approach is widely used in accelerated aging test medical device studies to estimate equivalent real time aging durations. By applying proper AAF values, manufacturers can confidently justify accelerated aging conditions while maintaining compliance with regulatory expectations, particularly for accelerated age testing for medical devices and accelerated aging for testing polymeric biomaterials and medical devices.

Sterile barrier system (SBS) and packaging validation

A Sterile Barrier System (SBS) must protect a device from contamination throughout its entire shelf life. Accelerated and realtime aging are essential to validate SBS performance. These tests ensure that packaging seals, materials, and protective layers withstand aging stress, environmental exposure, transportation, and storage. SBS validation is a key requirement of ISO 11607-1 and is a fundamental part of ASTM F1980 accelerated aging medical device packaging compliance. 

Accelerated aging vs real-time aging studies

Both methods serve different but complementary purposes:

• Accelerated aging provides rapid data to support initial shelf life claims and speed up regulatory approvals.
• Real time aging confirms true product performance over its entire shelf life and verifies accelerated aging assumptions.

Most manufacturers perform both in parallel—accelerated aging to accelerate market clearance and real time aging as the long term validation reference for medical device accelerated life testing.

Temperature and humidity controlled environmental chambers 

Environmental chambers simulate real-world and accelerated aging conditions with precise control of temperature and humidity. These chambers are essential for performing both real time aging medical device and accelerated studies, ensuring repeatable, reliable test conditions.

Post-aging functional and integrity testing 

After aging, devices undergo functional verification, mechanical evaluation, integrity inspection, and sterile barrier assessment. These post-aging checks confirm that the device performs as intended and that packaging remains intact, supporting claims validated during accelerated age testing medical device studies.

ISO/IEC 17025 Accreditation for ASTM F1980 testing 

Our accelerated aging testing is carried out in laboratories accredited according to ISO/IEC 17025, including specific accreditation for testing performed in accordance with ASTM F1980. This accreditation confirms that our testing methods, equipment, and laboratory competence meet the highest international standards for quality and reliability. 

ISO/IEC 17025 accreditation for ASTM F1980 provides a high level of confidence in accelerated aging study results, ensuring traceability, reproducibility, and technical robustness of the data generated. This is particularly important for validating the shelf life of medical devices, especially sterile barrier systems and packaging, where reliable aging data is critical to demonstrate long‑term performance and integrity. 

ASTM F1980: The standard for accelerated aging of medical devices

ASTM F1980 is the globally recognized standard that governs accelerated aging testing for medical devices, particularly for sterile barrier systems and packaging. It provides methodologies for applying elevated temperatures, calculating the Accelerated Aging Factor (AAF), and determining equivalent real time aging durations. Compliance with ASTM F1980 is required for many regulatory submissions, including FDA and EU MDR.

Benefits of real time and accelerated aging testing for Medical Devices

Engaging in real-time and accelerated ageing testing offers several critical benefits:

• Market Access: Expedites the process of bringing new products, particularly sterile medical devices, to market by providing evidence for shelf-life claims required for regulatory approvals like FDA 510k and CE marking.
• Compliance: Ensures adherence to international standards such as ISO 11607-1 and ASTM F1980, along with other regulatory requirements, demonstrating product safety and efficacy over its intended shelf life.
• Risk Mitigation: Helps identify potential issues with packaging integrity or device functionality over time, allowing manufacturers to address these before commercialisation, thus reducing the risk of product recalls or failures.
• Cost Efficiency: While real-time ageing is essential, accelerated ageing provides quicker insights, potentially saving time and resources in the product development cycle.
• Data-Driven Expiry Dates: Provides robust scientific data to support the expiry dates claimed for products, enhancing consumer trust and safety.
• Product Quality Assurance: Validates that the sterile barrier system maintains its integrity and that the medical device within remains functional throughout its stated shelf life.
• Support for Changes: Essential for when manufacturers make changes to their packaging processes or materials, ensuring these changes do not negatively impact product stability.

Why choose Applus+ Laboratories for real-time and accelerated ageing testing?

Choosing Applus+ Laboratories for your real-time and accelerated ageing testing needs provides you with a partner dedicated to quality, precision, and customer satisfaction.

• Accredited Expertise: Our laboratories operate under ISO 17025 accreditation (COFRAC), ensuring the highest standards of testing and calibration, providing results you can trust. Our expertise extends to commonly used standards like ASTM F1980 and ISO 11607-1.
• Regulatory Knowledge: We have extensive experience with regulatory requirements such as FDA 510k, MDR 2017/745, and CE marking, helping you navigate the complexities of product validation for different markets.
• State-of-the-Art Facilities: Our climatic chambers are equipped with precise temperature and humidity controls and continuous metrological monitoring, ensuring reliable and repeatable test conditions.
• Comprehensive Service: Beyond standard ageing tests, we offer comparative natural ageing studies and facilitate functional checks of your devices post-ageing.

By partnering with Applus+ Laboratories, you gain access to a wealth of experience and a commitment to helping you ensure your products meet the highest standards of safety and efficacy.