Medical Lab Testing: Melting, Crystallization, & Tg (DSC)
Melting, Crystallization, and Tg testing uses Differential Scanning Calorimetry (DSC) to precisely measure the temperatures at which polymers melt, crystallize, or transition from a glassy to a rubbery state. These thermal properties reveal a great deal about how a material will behave during processing, sterilization, storage, and in actual clinical use. For medical manufacturers, understanding these transitions is essential to ensure tubing, films, bags, catheters, implants, and resorbable devices perform consistently and safely.
Thermal behavior directly influences everything from how easily a polymer can be molded or extruded to how stable it remains after gamma sterilization or long-term storage. A material with the wrong melting point or glass transition temperature can become too soft, too brittle, or dimensionally unstable at body temperature or during shipping. Reliable Analysis already maintains accredited DSC capabilities alongside our full suite of polymer characterization tools, giving us a strong, ready-to-use foundation for medical-grade material evaluation.
These measurements support critical material qualification under ISO 10993 and USP standards. Manufacturers use melting, crystallization, and Tg data to verify resin consistency, predict long-term performance, and build robust regulatory documentation. Reliable Analysis delivers clear, well-interpreted thermograms using equipment already operating daily under our ISO/IEC 17025 accreditation.
Common Melting, Crystallization, and Tg (DSC) Testing Standards
ASTM D3418 Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
ASTM D3418 uses Differential Scanning Calorimetry (DSC) to determine the melting temperature (Tm), crystallization temperature (Tc), and associated enthalpies of fusion and crystallization in polymers. The test involves controlled heating and cooling cycles while measuring the heat flow difference between the sample and a reference. It is widely used for medical-grade polymers in tubing, films, bags, and molded components to characterize thermal transitions that influence processability, crystallinity, and final device performance.
ISO 11357-1 Plastics and subsequent parts for melting, crystallization, Tg
ISO 11357-1 outlines the general principles of Differential Scanning Calorimetry for plastics, with dedicated parts addressing melting temperature, crystallization behavior, and glass transition temperature (Tg). The standard ensures consistent test conditions, calibration, and data interpretation across laboratories. It is essential for medical polymers used in catheters, implants, packaging, and flexible devices to verify thermal properties that affect stability, sterilization compatibility, and mechanical behavior.
USP <891> Thermal Analysis
USP <891> describes the use of thermal analysis techniques, including Differential Scanning Calorimetry (DSC), to determine melting, crystallization, and glass transition behavior of materials. The chapter provides guidance on instrument qualification, method development, and interpretation of thermograms. It is commonly applied to medical-grade plastics, packaging films, and components that contact pharmaceutical products or sterile pathways to ensure consistent thermal properties and material quality.
ASTM E1356 Glass Transition Temperatures by Differential Scanning Calorimetry
ASTM E1356 provides a standardized procedure for determining the glass transition temperature (Tg) of polymers and other materials using DSC. The test involves heating the sample through the transition region and identifying the midpoint or inflection point of the step change in heat capacity. This method is particularly valuable for amorphous medical polymers and flexible components where Tg influences flexibility, dimensional stability, and performance at body or storage temperatures.
Your Partner for Medical Melting, Crystallization, and Tg (DSC)
Reliable Analysis stands ready to support your medical polymer thermal characterization and DSC testing needs. Our ISO/IEC 17025 accredited laboratory already maintains the necessary differential scanning calorimeters and supporting analytical capabilities, allowing us to efficiently add these medical standards with only minor validation and training.
Whether you are qualifying new tubing and films, validating resorbable implants, or ensuring consistency in medical-grade resins, 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 instead of 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.
