Medical Laboratory Testing: Accelerated Aging
Common Accelerated Aging Medical Testing Standards
ASTM F1980 Accelerated Aging of Sterile Barrier Systems
ASTM F1980 provides a standardized approach for accelerating the aging of sterile barrier systems using elevated temperature and humidity to simulate real-time shelf life. The guide uses the Q10 rule to calculate equivalent aging time and evaluates package integrity, seal strength, and barrier performance after aging. It is the primary method for medical packaging, gowns, drapes, and sterile wraps to predict how long they will maintain sterility under normal storage conditions.
ASTM D3045 Heat Aging of Plastics Without Load
ASTM D3045 outlines procedures for exposing plastic specimens to elevated temperatures in air ovens without applied load to simulate long-term thermal aging. The standard measures changes in physical, mechanical, and visual properties before and after exposure. It is commonly used for medical plastics in tubing, films, housings, and components to assess long-term thermal stability, color retention, and property degradation that may occur during storage or use.
ISO 11607-1 Packaging for Terminally Sterilized Medical Devices
ISO 11607-1 requires validation of sterile barrier systems, including the use of accelerated aging to demonstrate that packaging maintains sterility throughout its labeled shelf life. The standard combines elevated temperature and humidity to simulate real-time aging and evaluates seal strength, microbial barrier properties, and physical integrity. It is the key international standard for medical sterile packaging, gowns, drapes, and wraps.
ASTM D573 Deterioration in an Air Oven
ASTM D573 exposes rubber and elastomer specimens to elevated temperatures in air ovens to simulate long-term thermal aging. The standard measures changes in hardness, tensile strength, elongation, and other physical properties before and after aging. It is widely applied to medical seals, gaskets, tubing, and elastomeric components to predict how they will perform after extended storage or use at body or elevated temperatures.
Expert Laboratory Testing for Accelerated Aging
Applus+ Reliable Analysis stands ready to support your medical device and sterile packaging accelerated aging testing needs. Our ISO/IEC 17025 accredited laboratory already maintains the necessary environmental chambers and evaluation capabilities, allowing us to efficiently add these medical standards with only minor validation and training.
Whether you are validating new sterile barriers, establishing shelf life for implants and disposables, or qualifying materials for long-term storage, our team provides accurate and reliable data backed by decades of materials testing expertise. We invite you to Contact us to discuss how our expanded medical testing capabilities can support your next project or regulatory submission.
Additional Applus+ Reliable Analysis’ Commercial Medical Testing Capabilities
Whether it be material EMC, environmental, fabrication, or durability testing, Applus+ Reliable Analysis has a full lab of test equipment, which permits us to provide short lead times on scheduling. Our team strives to give our customers more time and energy on product development rather than testing.
Below is a list of common medical testing types that Reliable Analysis offers. Don’t see what you are looking for? Contact us, and we will determine the best course of action.
