Medical silicone oil and cosmetic silicone oil: differentiated design of biosafety
Biocompatibility requirements:


Medical silicone oil: It needs to pass ISO 10993 biocompatibility testing, including cytotoxicity (≤ level 1), skin sensitization (level 0), genetic toxicity (negative) and other indicators. It is commonly used for catheter lubrication, anti adhesion films, etc.
Cosmetic silicone oil: It must comply with the INCI naming convention, such as adding cyclic siloxane (D5) in skincare products at a dosage of up to 5%, but the volatile organic compound (VOC) content must be controlled to be less than 1%.
Function implementation path:
Medical silicone oil: chemically stable through hydroxyl or vinyl structures, can be retained in the body for more than 10 years without degradation; As an antifoaming agent for gastroscope, 0.1% concentration can eliminate more than 90% of foam.
Cosmetic silicone oil: Water solubility is achieved through polyether modification, such as PEG-10 polydimethylsiloxane, which can improve wet hair combing by 30% in shampoo; The adsorption of liquid foundation is enhanced by amino modification, so that the makeup holding time of foundation liquid can be extended to 12 hours.
Market regulatory differences: Medical silicone oil needs to obtain NMPA medical device registration certificate, and the production environment needs to achieve a cleanliness level of 100; Cosmetics silicone oil must be registered with CFDA, and heavy metal content (such as lead<10ppm, mercury<1ppm) is strictly limited.