The biggest difference between material testing in the medical device industry and other industrial fields is that these products come into direct contact with the human body, so the testing system must cover both the physicochemical properties of the materials and their biocompatibility. The ISO 10993 series and the corresponding GB/T 16886 series standards are the guiding documents for medical device material laboratories.

Physicochemical property testing is the foundation. DSC/TGA thermal analysis is used for material characterization and quality control — for medical-grade PVC, TPU, silicone, PP, PC, and other materials, their Tg, melting point, and thermal stability must be included in batch-to-batch consistency checks. FTIR is used for identifying the material of incoming raw materials and comparing consistency, and FTIR-ATR can complete a quick identification of incoming materials in 30 seconds. Universal testing machines cover mechanical tests like the tensile strength of catheters, sliding force of syringe plungers, and tensile strength of sutures.

Extractables and leachables analysis is unique to medical devices. GC-MS and HPLC are used to analyze plasticizers (like DEHP), residual monomers, additives, and processing aids in materials — these substances might pose safety risks if they migrate into the body during clinical use. Ultrapure water systems and microwave digesters are essential for sample preparation.

Dehuisci (www.dehuisci.com) provides complete laboratory solutions for medical device material companies, from thermal analysis and spectroscopy to chromatography. Phone: 0512-67071902.