Standards for silicone for adult products mainly include requirements for material safety, size specifications, hygiene standards, and appearance and physical properties.
Material safety standards
Material safety of silicone for adult products is the primary consideration. Common silicone materials such as silicone and TPE need to comply with relevant chemical migration limit standards. For example, silicone must comply with FDA testing standards to ensure that it does not contain harmful substances, such as heavy metal content must be strictly controlled, lead content must not exceed 10mg/kg, mercury content must not exceed 1mg/kg, etc. TPE materials must also meet the EU REACH regulations for the control of harmful substances.
Size specification standards
There is no unified national standard for the size specifications of adult products, but the common length is between 15 and 25 cm and the diameter is between 3 and 5 cm to meet the use needs and comfort of most users. The error of dimension marking should be controlled within a reasonable range, such as the length error is ±1 cm and the diameter error is ±0.5 cm.
Hygiene standards
The hygiene standards of adult products are also very important. The total number of bacterial colonies on the surface of the product shall not exceed 200 CFU/g, the total number of molds and yeasts shall not exceed 100 CFU/g, and pathogenic bacteria such as Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa shall not be detected. The production process must comply with the requirements of medical device production quality management specifications for hygiene control, and the production workshop must reach a certain degree of cleanliness, such as the 100,000-level clean workshop standard, to reduce microbial contamination during the production process.
Appearance and physical performance standards
The appearance of adult products should be smooth, without obvious defects, and uniform in color. In terms of physical properties, adult products made of silicone must have certain tensile and bending resistance. For example, adult products made of silicone must not break or tear under a certain tensile force (such as a tensile force of 50N); after a certain number of bending tests (such as 500 times), the product performance should remain stable without deformation, damage, and other problems.
