Medical Device Stability Testing

Applus+ Laboratories provides stability testing services to ensure that a medical device can maintain its performance and reliability in order to comply with EU regulatory requirements. Stability testing is the final stage of our batch release testing, where we also offer:

• Biocompatibility testing
• Cleaning validation
• Packaging validation
• Material and chemical characterisation

What Is Medical Device Stability Testing?

Stability testing is an essential step in overall medical device testing. Stability testing is crucial to validate the shelf life and to assess whether a medical device (non-invasive and invasive), implant (joint implants, bone cement, etc) and even its packaging is stable over time and does not present any crucial modification during storage or during use.

What Stability Testing for Medical Devices Do We Offer?

We provide the full range of stability testing for medical devices. We perform both accelerated ageing tests according to ASTM 1980 and natural ageing test in order to assess stability in different storage situations, as well as offering customised testing for specific product needs. Here’s a full rundown of the services we offer.

Accelerated Aging Tests according to ASTM F1980 and natural ageing or according to customer specifications

Natural and accelerated ageing testing are essential for assessing how medical devices and packaging perform over time. These tests ensure that your medical device and its packaging will remain stable over time as well as during storage. We test according to the standard ASTM F1980.

• Development and Validation of ‘On Demand’ Method: We offer a specialised ‘on demand’ service creating tests tailored to the specific needs of a particular medical device. We offer this for unique and novel designs using novel materials, where standard test methods may not accurately predict its stability or the kinetics of its degradation and release profiles. This service aligns with our desire to boost innovation in the industry, providing the relevant, customised testing to cater to client needs.
   
• Product Performance Stability During Lifetime: We test the performance of medical devices and how stable they are over their lifetime. These are critical tests and include accelerated life testing, real-time aging, as well as cyclic fatigue testing. We test the device to see whether it can endure the physiological strains, chemical condition-s, and biological stresses it will undergo during its lifespan.
   
• Storage Stability: Storage stability is a vital part of stability testing since it ensures how well a medical device maintains its quality and safety when it is stored. This requires assessing the medical devices physical and chemical stability reacting to temperature, humidity and light exposure. We also determine shelf life to ensure that the product will last under various conditions. This helps in completing the regulatory requirement of your medical devices
   
• Packaging integrity over time: We evaluate the integrity of the packaging after natural or accelerated ageing.

Shelf life testing 

Shelf-life testing evaluates how a medical device performs under realtime storage conditions. This long-duration study provides definitive evidence that the device maintains its safety, functionality, sterility, and packaging integrity throughout its intended lifespan. Shelf-life studies support accurate expiry date assignment and are crucial for regulatory compliance and medical package stability testing, helping ensure products remain reliable until the end of their declared shelf life. 

Accelerated stress testing 

Accelerated stress testing exposes medical devices to extreme or exaggerated environmental, mechanical, or chemical conditions—far beyond normal use—to identify potential failure modes. These tests help predict how materials degrade, how packaging responds to harsh conditions, and whether the device can tolerate unexpected stresses. This approach supports innovative product development and ensures compliance with stability testing medical devices expectations for durability and robustness. 

Life cycle testing 

Life cycle testing evaluates how a medical device performs throughout its entire expected lifespan, simulating real world conditions such as mechanical fatigue, thermal cycling, chemical exposure, and repetitive use. These studies verify long-term performance, mechanical reliability, and material stability. Life cycle testing is especially important for implants, reusable devices, and systems exposed to continuous stress, contributing to compliance with medical device stability testing requirements.

Examples of Stability Testing Tests We Perform For Medical Devices

Here are some examples of stability testing we perform according to different standards:

• Analyses of Kinetics of Degradation: We test polyester-based implants according to standard ISO 13781 to analyse the rate and mechanism by which they degrade during implantation. This assesses how the implant will behave under physiological conditions, including the rate of absorption, mechanical integrity, and the release of byproducts.
   
• Stability Testing for Bone Cements: We conduct stability testing on bone cements to ensure their mechanical integrity, chemical stability, and chemical release profile are maintained over time.
   
• Degradation Product Identification according to ISO 10993-13; 14 and -15: We test according to ISO 10993-13 to ensure the safety of medical devices that are made from polymers and are subject to degradation in the body. This involves analysing the polymeric materials in medical devices and to assess chemical nature of the degradation product as well as how much degrades over time. A problem could occur as well with metallic implant with corrosion issue and leachable of metallic particles.

Requirements Of Stability Testing For Medical Devices 

Stability testing medical device requirements are defined by global regulatory bodies to ensure that medical devices remain safe and effective throughout their intended shelf life. These requirements typically include: 

• Demonstrating material, functional, and packaging stability requirement of ISO 11607-1, under real-time and accelerated conditions 
• Conducting chemical, mechanical, and biological assessments to detect degradation or performance changes. 
• Evaluating packaging integrity and sterility maintenance for medical package stability ISO 11607-1. 
• Establishing scientifically justified shelf-life claims supported by validated test data. 
• Ensuring compliance with ISO, ASTM, and regional regulatory frameworks such as MDR, FDA, and international standards. 

Meeting these requirements is essential for global market approval and for maintaining device reliability and patient safety. 

What Are the Benefits of Stability Testing For Medical Devices?

Stability testing is a crucial component of our batch testing services and offers numerous benefits, including ensuring patient safety and maintaining compliance with medical device standards. These advantages include the following:

• Performance and Reliability: Stability testing confirms that your product maintains its intended performance and reliability under various stress scenarios throughout its shelf life. This ensures that the product functions as expected when used by patients.
   
• Patient Safety: By validating the stability of your product, we minimise the risk of adverse effects from materials interacting with bodily fluids or tissues over time. This significantly reduces the potential for toxicity, ensuring the product stays safe for patient use throughout its lifespan.
   
• Compliance with Regulatory Requirements: Stability testing ensures adherence to the stringent standards required for medical devices. This compliance boosts consumer trust by demonstrating that your product remains effective and safe over its intended shelf life.
   
• Risk Minimisation: Stability testing identifies potential risks associated with product degradation over time and provides guidance on necessary adjustments to mitigate these risks. This enhances both patient safety and consumer confidence in your product.
   
• Market Access: Complying with stability standards for medical devices enhances your market access on a global scale. Achieving the necessary certifications allows you to operate in multiple countries, expanding your market reach.

Key Standards For Medical Device Stability Testing 

Several key standards define how stability testing for medical devices must be performed, covering aging studies, packaging integrity, degradation behavior, and performance testing. These may include: 

• ASTM F1980 for accelerated aging 
• ISO standards related to chemical and material degradation 
• ISO 11607 for packaging performance 
• ISO 10993 for material biocompatibility and chemical stability evaluation 
• Product‑specific standards depending on device classification 

These guidelines ensure stability testing is scientifically robust, repeatable, and internationally accepted. 

Why Choosing Applus+ Laboratories for Stability Testing?

Applus+ Laboratories strives to be a one-stop shop for medical device testing, offering a full suite of services that can accelerate your time to market. We offer:

• Development testing and advice on stability enhancements
• Full lifecycle stability testing
• Product and process qualification with stability assessments
• Prototyping services

We provide high-quality, ASTM and ISO-compliant stability testing services that ensure the accuracy and reliability of your medical devices over time. Our comprehensive range of testing capabilities, coupled with our commitment to client service, makes us the ideal partner for your stability testing needs.

With a presence in multiple countries, we can deliver our testing services to customers around the world, ensuring you have access to the best medical device testing no matter where you are.

Let Applus+ Laboratories be your trusted partner for all your medical device testing needs. We can support your projects with our high-quality services and expert guidance.