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 tests involve subjecting samples to elevated temperatures in order to speed up the normal aging process of the samples and simulate real-time aging. This is done to estimate the lifespan of a product and provide an accurate estimation of shelf-life when actual lifespan data is unavailable. Aging refers to the process by which properties of a product change over time. Aging studies are used to determine how a product behaves under normal storage/use conditions over long periods of time. The product is subjected to levels of stress that exaggerate normal conditions so the changes can be observed over a shorter timeframe. The technique many accelerated aging studies adopt is based on the assumption that the chemical reactions involved in the deterioration and degradation of materials follow the Arrhenius’ reaction rate law. This law states that the aging rate will double with every 10 °C increase in temperature (Q10).
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.
Frequently Asked Questions
What is Accelerated Aging Testing for medical devices?
Accelerated Aging Testing is a controlled process used to estimate the shelf life and long‑term performance of medical devices in a shorter timeframe. Products are exposed to elevated stress conditions, such as increased temperature and humidity, to simulate natural aging and predict how they will perform over time.
Why is accelerated aging required for regulatory submissions?
Medical devices must be labelled with an expiration date supported by scientific data. Accelerated aging provides the evidence required for technical documentation and regulatory submissions, including CE marking and FDA pathways such as 510(k), demonstrating that the device remains safe and effective throughout its claimed shelf life.
Which standards are used for accelerated and real‑time aging studies?
Accelerated and real‑time aging studies are conducted in line with recognised standards, including ASTM F1980 for accelerated aging and ISO 11607 for packaging of terminally sterilised medical devices. These standards ensure the data generated is suitable for regulatory use.
What is the difference between accelerated aging and real‑time aging?
Accelerated aging uses elevated stress conditions to rapidly estimate product lifespan, while real‑time aging involves storing products under recommended conditions and assessing them at defined intervals over time. Real‑time studies are often run alongside accelerated aging to confirm and validate shelf‑life claims.
What types of products can benefit from accelerated aging testing?
Accelerated aging testing is applicable to a wide range of medical devices, including sterile devices, devices with packaging systems, and disinfectant products. It helps assess material stability, packaging integrity, and functional performance over the product’s intended storage and use period.