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.
✅ Want to understand the full scope of how we test silicone products?
Read our Advanced Testing Methods for Silicone for complete insight.
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 |
| Cadmium (Cd) | US EPA 3052:1996 & US EPA 6010D:2018/ICP-OES | N.D. | 2 |
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.
See also:
- Importance of Biocompatibility Testing
- Comprehensive Guide to GC-MS Testing in Silicone
- Environmental Safety Standards for Silicone
- ICP-OES for Silicone Rubber Test Report (Sample)
- Proposition 65 Safety Tests for Silicone
- Silicone Rubber Products and RoHS: Regulatory Compliance Guidelines
- Understanding EN 71-3 Testing Methods for Silicone Rubber