Accelerated and Real-Time Aging Testing Services for Medical Devices

Test Labs Ltd provides comprehensive accelerated and real-time aging testing services to evaluate the stability of products under various storage and use conditions. Accelerated aging testing simulates long-term aging processes by exposing products to elevated stress conditions, such as increased temperature and humidity, over a shorter period. This method allows for fast evaluation of shelf-life and performance, supporting data required for regulatory submissions such as 510(k) approvals. In contrast, real-time aging testing assesses product stability over time under controlled conditions closely mirroring normal usage environments, ranging from 20°C to 25°C. This dual approach ensures robust validation of long-term product efficacy and safety. Test Labs also specializes in medical device testing services, including biocompatibility, bioburden testing, and sterilization validation, following standards such as ASTM F1980 and ISO 11607-1:2019. Their facilities are equipped with cutting-edge microbiology and chemistry laboratories, alongside state-of-the-art test chambers, to support product development and regulatory compliance.

ASTM F1980 Accelerated Ageing

Accelerated stability testing exposes products to elevated stress conditions such as temperature, humidity over a shorter time frame. This approach enables a faster evaluation of stability under adverse conditions, allowing for the assignment of shelf-life periods.

ASTM F1980 Real-Time Ageing

Real-time stability testing involves storing the product under recommended conditions and evaluating it at periodic intervals until it no longer meets the specified criteria. This method provides a comprehensive, longterm assessment of the product's stability under real-world conditions. It is often used alongside accelerated aging data to validate and confirm the product’s shelf life and overall performance.

ISO 11607-1:2019

Packaging for terminally sterilized medical devices. It specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

Accelerated and Real Time Ageing Testing

Every medical device must be labelled with an expiration date supported by scientifically validated shelf-life data. To achieve this, accelerated ageing tests are conducted to generate data for, technical files and regulatory submissions such as 510(k) approvals. These accelerated studies are typically run alongside real-time ageing tests to ensure comprehensive validation. At Test Labs, we support manufacturers by providing end-to-end testing services, helping to meet regulatory requirements and streamline the product approval process efficiently.

What is Accelerated Ageing Testing?

Accelerated aging testing is a controlled procedure used to estimate the shelf life and functional lifespan of a product in a significantly shorter time frame. This method is particularly valuable when actual lifespan data is unavailable or impractical to obtain in real-time. The process involves exposing samples to elevated temperatures and other stress factors to simulate the natural aging process. By accelerating material degradation under controlled conditions, manufacturers can predict long-term performance, identify potential failures, and ensure compliance with regulatory standards before the product reaches the market.

What is Real Time Ageing Testing?

Real-time aging is a stability testing process used to gather actual data on the shelf life and aging effects on materials over time. The packaged product is stored under controlled conditions, such as specified temperature and relative humidity, to simulate typical storage environments. These tests are usually conducted at ambient temperatures ranging from 20°C to 25°C, providing reliable data on the product’s longevity and performance over its expected lifespan.

Why is Medical Device accelerated aging important?

Medical devices need to be able to have long shelf/storage life without it leading to a deterioration in device performance in terms of safety and efficacy. If the devices are stored in sterile packaging, the loss of that sterile barrier system over time can also lead to deterioration/degradation of certain properties of the medical device materials and adhesive components. Similarly, disinfectant products also require stability and shelf-life assessments prior to being put on the market, where the stability of chemical, physical and antimicrobial properties are evaluated after putting the product through aging studies.