Medical Laboratory Testing: Thermo Oxidative Stability
Thermo Oxidative Stability testing evaluates how well polymers, elastomers, coatings, and composites resist degradation when exposed to heat and oxygen over time. The test typically places specimens in air-circulating ovens at elevated temperatures and measures changes in physical, mechanical, and visual properties before and after aging. For medical manufacturers, this data is crucial to predict long-term performance and ensure materials in tubing, seals, implants, and reusable components remain reliable throughout their shelf life and clinical use.
Oxidative degradation can cause embrittlement, discoloration, loss of elasticity, or reduced strength, which may compromise device safety or functionality. Applus+ Reliable Analysis already maintains accredited thermal aging capabilities with precise oven systems that allow us to run controlled thermo-oxidative studies alongside our full suite of polymer characterization, mechanical, and chemical analysis methods.
These evaluations support material qualification and stability requirements under standards such as ISO 10993-18 and ASTM methods for long-term performance. Manufacturers use thermo-oxidative stability data to select robust formulations, establish realistic shelf life, and demonstrate that products will withstand real-world storage and use conditions without significant degradation. Applus+ Reliable Analysis delivers consistent, reproducible results using equipment already operating daily under our ISO/IEC 17025 accreditation.
Common Thermo Oxidative Stability Medical Testing Standards
ASTM D573 Rubber Deterioration in an Air Oven
ASTM D573 evaluates the thermo-oxidative stability of rubber and elastomeric materials by exposing specimens to elevated temperatures in an air-circulating oven for specified periods. The test measures changes in hardness, tensile strength, elongation at break, and other physical properties before and after aging. It is widely used for medical seals, gaskets, tubing, and flexible components to predict how these materials will perform after long-term exposure to oxygen and heat, helping ensure they maintain elasticity and sealing performance throughout their service life.
ISO 11346 Estimation of Life-Time and Maximum Temperature of Use
ISO 11346 provides a method for estimating the lifetime and maximum use temperature of vulcanized or thermoplastic rubbers under thermo-oxidative conditions. The standard uses accelerated aging data at multiple temperatures to extrapolate long-term performance using Arrhenius relationships. It is particularly valuable for medical elastomers and flexible components to determine safe operating temperatures and predict shelf life or in-service durability under oxidative stress.
ASTM D3045 Heat Aging of Plastics Without Load
ASTM D3045 outlines procedures for heat aging of plastics in air ovens without applied mechanical load. The standard measures changes in physical, mechanical, and visual properties after exposure to elevated temperatures to simulate long-term oxidative and thermal effects. It is commonly used for medical plastics in housings, films, tubing, and rigid components to assess color stability, embrittlement, and retention of mechanical properties during storage and use.
ASTM D3013 Thermosetting Resin Glass Laminates with Thermo-Oxidative Focus
ASTM D3013 evaluates the thermo-oxidative stability of thermosetting resin glass laminates by exposing specimens to elevated temperatures and assessing changes in flexural strength, appearance, and other properties. The method helps predict long-term performance under oxidative conditions. It is relevant for reinforced medical composites and structural components where oxidative stability is important for maintaining mechanical integrity over the product lifecycle.
Your Partner for Expert Thermo Oxidative Stability Testing
Applus+ Reliable Analysis stands ready to support your medical material thermo-oxidative stability and long-term aging testing needs. Our ISO/IEC 17025 accredited laboratory already maintains the necessary air-circulating ovens and supporting evaluation capabilities, allowing us to efficiently add these medical standards with only minor validation and training.
Whether you are qualifying new tubing and seals, validating implants or reusable components, or establishing shelf-life data, our team provides accurate and reliable results 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.
