Silicone Testing for Medical Devices
Silicone rubber is used in medical devices for its flexibility, durability, and safety. Tests ensure it meets international standards and is free from harmful substances.
Silicone Testing Methods for Medical Devices
We use advanced methods like Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) and Gas Chromatography-Mass Spectrometry (GC-MS) to detect hazardous substances in silicone products.
Tested Substances and Results for Silicone Testing of Medical Devices
| Tested Substance | Method Used | Result (mg/kg) | MDL (mg/kg) |
|---|---|---|---|
| Lead (Pb) | IEC 62321-5:2013 | N.D. | 50 |
| Cadmium (Cd) | IEC 62321-5:2013 | N.D. | 50 |
| Mercury (Hg) | IEC 62321-4:2013 | N.D. | 50 |
| Hexavalent Chromium (Cr(VI)) | IEC 62321-7-2:2017 | N.D. | 9 |
| Polybrominated Biphenyls (PBBs) | IEC 62321-6:2015 | N.D. | N/A |
| Polybrominated Diphenyl Ethers (PBDEs) | IEC 62321-6:2015 | N.D. | N/A |
| Phthalates (DBP, BBP, DEHP, DIBP) | IEC 62321-8:2017 | N.D. | N/A |
Compliance with International Standards
Our silicone meets international standards like ISO 10993 for biological evaluation and USP Class VI for medical-grade materials. These standards ensure our silicone is safe for medical devices.
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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