Hangzhou CIRS C&K Testing Technology Co., Ltd. officially inaugurated its new toxicology laboratory in August. Located in the Tianhe High-tech Industrial Park in the Binjiang District of Hangzhou, Zhejiang Province, this lab is to provide toxicological tests and research services to industries such as cosmetics, medical devices, health products, specialty foods, and pharmaceuticals.

Reusable medical devices should be user-friendly and convenient for efficient cleaning and necessary disinfection or sterilization. Manufacturers of medical devices should adequately specify information on cleaning, disinfection, or sterilization. At the same time, the manufacturer should keep the verification records of the relevant reprocessing information according to the requirements of the Good Manufacturing Practice for Medical Devices, to prove that the reprocessing information has been verified and is easy for users to understand and operable.

Good biocompatibility is a prerequisite for safe and effective clinical application of medical devices. Biological evaluation of medical devices to determine the risk level of potential toxicity and adverse biological reactions caused by contacting human body is the basis of benefit-risk evaluation of medical devices as a whole. Biocompatibility test is an important part of biological evaluation and provides a solid guarantee for biological evaluation.

Leachable substances refer to chemical substances released from medical devices and related liquids, such as monomers, additives, sterilizers, process residues, degradation products, etc. When medical devices are working, leachable substances also produce short-term or long-term safety hazards to human body. Therefore, research on the safety of leachable substances is not only the focus of enterprises in the stage of product design and development, but also the focus of relevant product technology review.

Chemical characterization of materials is a part of the overall biological safety of a medical device, which can be applied in the identification of materials and the qualitative and quantitative analysis of chemical substances present in materials or finished medical devices. By means of chemical characterization, some long-term tests in biocompatibility tests can be exempted, such as subchronic toxicity, chronic toxicity, long-term implantation, etc.