Biocompatibility refers to the ability of biological materials to interact with a host's specific environment and sites, either directly or indirectly, without causing harmful reactions or damage. It is the biological characteristic of a material being able to withstand the dynamic changes within a biological system, remaining stable and not being rejected or destroyed. For lubricants, biocompatibility means that when the product comes into contact with human tissue, cells, or bodily fluids during use, it will not trigger harmful reactions or cause damage.
Biocompatibility testing for medical lubricants typically includes a series of experiments and evaluations such as acute toxicity testing, intradermal reaction testing, pyrogen testing, in vitro hemolysis testing, cytotoxicity testing, and sensitization testing. These tests aim to comprehensively assess the safety and biocompatibility of the lubricant within the body.
The significance of biocompatibility for medical lubricants is critical. It is not only a key factor in ensuring product safety, but also plays an essential role in safeguarding the functionality of medical devices, complying with regulatory requirements, and enhancing user experience to ensure safe use. Therefore, selecting lubricants that have passed biocompatibility evaluations and tests is more reliable during the development, production, and sale of medical devices.
Baoxing has always prioritized product quality and safety. Our medical lubricants were among the first to apply for biocompatibility testing and receive approval. Our production facilities are ISO 21469 certified and equipped with a cleanroom rated to class 10,000. Baoxing's medical lubricants have passed six biocompatibility certifications, widely recognized in the industry.
· Acute Toxicity Testing: Assesses the toxicity effects of the lubricant under acute exposure conditions.
· Intradermal Reaction Testing: Evaluates whether the lubricant causes skin irritation or allergic reactions upon skin contact.
· Pyrogen Testing: Checks for substances in the lubricant that may cause fever reactions.
· In Vitro Hemolysis Testing: Assesses the extent of red blood cell destruction caused by the lubricant in vitro.
· Cytotoxicity Testing: Evaluates the lubricant's effect on cell growth and survival.
· Sensitization Testing: Determines whether the lubricant has potential sensitizing properties.
In addition to passing the six biocompatibility certifications, Baoxing's medical lubricants also meet various international standards and certification requirements, such as ISO 21469 certification and NSF H1/3H certification. Adhering to these standards ensures the high quality and safety of Baoxing medical lubricants. Baoxing medical lubricants have extensive applications in the medical industry, including the lubrication and maintenance of medical devices and instruments, as well as the manufacturing and assembly of medical equipment. Their excellent performance and safety have earned widespread recognition and trust within the medical industry.
