Medical Grade Silicone: Standards, Certifications, and What They Mean for Your Application
2026,08,19
The term "medical grade silicone" is widely used but often misunderstood. Not all silicones labeled as medical grade are the same, and different applications require different levels of certification and testing. Understanding medical silicone standards helps manufacturers make informed material selection decisions.
Key standards and certifications for medical and skin-safe silicone: -
FDA Food Contact — Indicates silicone is safe for contact with food. Often used as a baseline for skin safety.
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ISO 10993 — Biological evaluation of medical devices, including cytotoxicity, sensitization, and irritation testing.
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USP Class VI — United States Pharmacopeia standard for plastics and elastomers used in medical applications.
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RoHS — Restriction of Hazardous Substances directive, relevant for electronic and robotics applications.
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REACH — European regulation on chemicals and their safe use.
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ISO 9001 — Quality management system certification for the manufacturing process.
When selecting silicone for medical or skin-contact applications, it is important to match the certification level to the specific application requirements. Not all applications require full medical device certification, but skin-contact applications should at minimum use materials with proven biocompatibility.Hong Ye Silicone's Y-series robot skin silicone holds FDA, RoHS, and REACH certifications, with ISO 9001 quality management ensuring consistent production quality.Key Takeaways: -
Key certifications include FDA, ISO 10993, USP Class VI, RoHS, and REACH
Shenzhen Hong Ye Jie Technology Co., Ltd