Medical device shelf life testing services

Medical device shelf life testing is a laboratory service used to evaluate whether both the medical device and its sterile barrier system (packaging) maintains its safety, performance, and packaging integrity throughout its declared shelf life. At Applus+ Laboratories, shelf life testing medical device services are conducted to generate data related to material stability, packaging performance, and functionality over time. 

These activities support medical device shelf life studies across development, validation, and lifecycle management stages. 

What is medical device shelf life testing? 

Medical device shelf-life testing is designed to assess how a device and its packaging perform over time when stored under defined conditions. The objective is to evaluate whether critical properties of medical devices remain within acceptable limits, and if the packaging also remains sterile until the end of the claimed shelf life. 

A medical device shelf life services may include real‑time aging, accelerated aging, or a combination of both, depending on the device type and validation strategy. 

Key factors of shelf life testing for medical devices 

Shelf life testing for medical devices considers multiple factors that may affect long‑term performance, including: 

• Material stability and degradation 
• Packaging integrity and protective performance 
• Effects of sterilization over time 
• Environmental storage conditions 
• Transportation and handling stresses 

These factors are evaluated using defined shelf life testing methods for medical devices appropriate to the product configuration.

Our shelf life testing methods for medical devices 

Applus+ Laboratories applies recognized shelf life international standards and guidelines  based on device design, materials, and intended storage conditions. 

Accelerated aging testing 

Accelerated aging testing is used to simulate long‑term storage effects over shortened timeframes by applying elevated temperature and controlled relative humidity conditions. This method is commonly used to support shelf life claims during development. 

Medical device stability testing

Stability testing is a key step in medical device evaluation, used to confirm shelf life and ensure that devices, implants, and their packaging remain stable over time without significant changes during storage or use.We also provide customised testing solutions tailored to specific device designs and materials when standard methods are not sufficient.

Our medical device and packaging shelf life testing services 

Applus+ Laboratories provides medical device shelf life and Packaging shelf life  testing through integrated testing services covering materials, packaging, and performance stability. 

Packaging validation 

Packaging validation assesses whether the packaging system continues to protect the device throughout its shelf life. This includes evaluation of seals, materials, and packaging performance after aging and whether or not combined with transport simulation tests. 

Distribution simulation and transit testing 

Distribution simulation and transit testing evaluate the effects of transportation, handling, and mechanical stresses on packaged medical devices. These tests are used to assess packaging and device performance after simulated shipping conditions. 

Accelerated and real‑time aging 

Accelerated and real‑time aging studies are performed individually or in parallel as part of a medical device shelf life study. Real‑time aging provides data based on actual storage duration, while accelerated aging supports early performance evaluation. 

Additional shelf life‑related services 

Additional services associated with shelf life testing include: 

• Chemical characterization after aging 
• Functional performance testing post‑aging 
• Sterile barrier system evaluation 
• Visual inspection and material integrity assessment 

Common standards for shelf life validation 

Medical device shelf life validation activities are aligned with internationally recognized standards used for packaging, aging, and stability evaluation. 

ASTM F1980 

ASTM F1980 specifies methods for accelerated aging of sterile barrier systems for medical devices. This standard is commonly used to establish aging conditions and calculate accelerated aging factors. 

Additional standards, like ICH (International Council for Harmonisation) guidelines on stability testing, may apply depending on packaging type, sterilization method, and device classification. 

Benefits of shelf life testing for medical devices 

Medical device shelf life testing provides: 

• Data on long‑term stability and performance 
• Evaluation of packaging integrity over time 
• Assessment of storage and distribution effects 
• Support for defined shelf life claims 
• Objective evidence for design and lifecycle evaluations 

Why choose Applus+ Laboratories for medical device shelf life testing services? 

Applus+ Laboratories offers medical device testing services through a global network of specialized testing laboratories with experience across medical technologies. 

• Technical expertise in aging, packaging, and performance testing 
• Integrated shelf life testing services under one laboratory network 
• Testing aligned with applicable international standards and ISO 17025 accredited laboratories 
• Lifecycle support from development through post‑market evaluation 
• Global presence enabling consistent testing methodologies 

These capabilities position Applus+ Laboratories as a qualified provider of shelf life testing medical device services for a wide range of medical products.