Medical Devices
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Cleaning, Disinfection, Sterilization Process Validation
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.
Cleaning Room Testing
Nucleic acid test booths, hospitals, medical device production plants, pharmaceutical plants, and biosafety laboratories have different levels of requirements for clean environments.
Stability Test
Stability Test
Microbiological Testing
Strict control of microorganisms is an important quality control requirement in the R&D and production for medical device products (especially for non-active medical device products). Microbial control occupies an important position in the quality requirements of medical devices, and is also an important parameter reflecting the quality control system of medical device production. Most medical device products that come into contact with the human body require microbial limit testing.
Biocompatibility Testing
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.
Safety Evaluation for Leachable Substances
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
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.


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