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.
