In the process of registration review and manufacturing regulation, medical devices such as polymeric materials and dressings are tested for relevant raw residual monomers, binders, release agents, plasticizers (e.g., DEHP) or other additions, contaminants, and other ingredients that require controlled levels, as well as prohibited substances, to verify product safety. include:
Adhesive: cyclohexanone (CYC)
Untransformed raw materials and monomer residue: vinyl chloride monomer (VCM), lactide monomer in implant, bisphenol based propane (BPA), etc
Plasticizers: di - (2-ethylhexyl) phthalate (DEHP), trioctyl metabenzoate (totm), etc
Sterilization agent and sterilization product residue: ethylene oxide (EO), 2-chloroethanol (ECH), etc
Chemical drug identification and content determination: chemical components with anti-inflammatory, analgesic, antipyretic efficacy, hormones, etc., in the adherent instruments
Heavy metal ions, elements, etc., in various instruments
Various types of conventional physicochemical analytes, various types of organic and inorganic substances analyzed by chromatographic and spectroscopic methods, substances identified by infrared methods, etc