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Biocompatibility Testing for Silicone Devices

Silicone rubber is widely used in medical devices for its flexibility, durability, and biocompatibility. Ensuring the biocompatibility of silicone is crucial to confirm that it does not cause adverse reactions when in contact with human tissues. This report outlines the biocompatibility testing processes and standards our silicone products meet to ensure safety and compliance for medical applications.

Importance of Biocompatibility Testing

Biocompatibility testing ensures that:
  1. Silicone devices do not cause cytotoxicity, sensitization, or irritation.
  2. Products comply with international standards like ISO 10993 and USP Class VI.
  3. Manufacturers and users can trust the safety of silicone products in medical applications.
Testing Methods Our biocompatibility testing includes:
  1. Cytotoxicity Testing: Checks if silicone causes cell death.
  2. Sensitization Testing: Evaluates potential allergic reactions.
  3. Irritation Testing: Determines if silicone causes skin or mucous membrane irritation.
We also use techniques like Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) and Gas Chromatography-Mass Spectrometry (GC-MS) to detect residual chemicals affecting biocompatibility.
Test Results The following table summarizes the key substances tested and their results, confirming that our silicone products are biocompatible and safe for medical use.
Tested SubstanceMethod UsedResult (mg/kg)MDL (mg/kg)
Lead (Pb)IEC 62321-5:2013N.D.50
Cadmium (Cd)IEC 62321-5:2013N.D.50
Mercury (Hg)IEC 62321-4:2013N.D.50
Hexavalent Chromium (Cr(VI))IEC 62321-7-2:2017N.D.9
Polybrominated Biphenyls (PBBs)IEC 62321-6:2015N.D.N/A
Polybrominated Diphenyl Ethers (PBDEs)IEC 62321-6:2015N.D.N/A
Phthalates (DBP, BBP, DEHP, DIBP)IEC 62321-8:2017N.D.N/A

Compliance with International Standards

Our silicone products comply with these standards:ISO 10993: Biological evaluation of medical devices. USP Class VI: Biological reactivity tests for medical-grade materials.

References

  • IEC 62321 Series: Determination of Certain Substances in Electrotechnical Products.
  • ISO 10993: Biological Evaluation of Medical Devices.
  • USP Class VI: Biological Reactivity Tests, In Vivo.
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