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Possess 800 square meters of Class 10,000 dust-free workshop, Passed ISO9001:2015 quality management system certification and ISO13485:2016 medical device quality management system, and its products have obtained multiple biocompatibility tests, US FDA and EU LFGB certifications.
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ISO 9001:2015
ISO 13485:2016
ISO 10993－11:2017 Tail vein injection
ISO 10993－11:2017 Intraperitoneal injection
ISO 10993－11:2017 Pyrogens
Skin irritation test for extract of 0.9% sodium chloride injection
Skin irritation test for sesame oil extraction
Skin sensitization test in guinea pigs using the maximization method with 0.9% sodium chloride injec
Skin sensitization test in guinea pigs:maximization method with sesame oil extraction
Cell toxicity test:agar diffusion method
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Our silicone accessories meet international medical standards through strict quality control.
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Our silicone accessories meet international medical standards through strict quality control.
Ensure patient safety with our premium products. Explore our catalog today!
What is the difference between food grade and medical-grade silicone?
Time： 2025-06-26 10:35:34
Author： Guangdong Exnan Technology Co.,Ltd
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While both are safe for their intended uses, medical-grade silicone undergoes stricter testing and refinement for biocompatibility within the body. Food-grade silicone is approved for food contact but doesn't meet the biological compatibility requirements for medical applications.
Q: What is the difference between food grade and medical-grade silicone?
A: While both are safe for their intended uses, medical-grade silicone undergoes stricter testing and refinement for biocompatibility within the body. Food-grade silicone is approved for food contact but doesn't meet the biological compatibility requirements for medical applications.
Q: What is the medical-grade silicone standard?
A: In the United States, medical-grade silicone is primarily tested against the USP Class VI standard. This United States Pharmacopeia (USP) certification requires materials to pass rigorous testing for cytotoxicity (cell damage), skin sensitization (allergic reactions), and acute systemic toxicity to ensure safety in medical devices.
Q: What is food grade silicone standard?
A: Food-grade silicone meets standards set for safe, repeated contact with edible products. Its formulation minimizes flavor transfer (taint) and bacterial accumulation, ultimately lowering maintenance costs. These FDA-approved materials (like VMQ silicone) typically function across temperatures from -50 °C/-58 °F to +175 °C/+347 °F, with brief tolerance up to +230 °C/+446 °F.
Q: What is the difference between medical and industrial silicone?
A: The key difference lies in purity and additive composition. Medical-grade silicone uses highly purified base materials and avoids additives harmful to biological systems. Industrial silicone might contain fillers or compounds safe for machinery or construction but unsuitable (and potentially harmful) for direct, prolonged contact with body tissues or fluids.
Q: How to know if silicone is medical grade?
A: Look for compliance with specific biocompatibility standards like USP Class VI certification. Medical-grade silicone typically carries this designation or an equivalent (some older classifications include Class V). Manufacturers and material suppliers usually provide documentation confirming the grade and intended medical use.
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Hey there, I’m Steve!
15+ years in medical silicone accessories, linking manufacturers and healthcare providers for compliant, high-quality products. Trusted advisor focused on innovation and patient care. If you are looking for custom-made silicone rubber products, feel free to ask me any questions.
Hey there, I’m Steve!
15+ years in medical silicone accessories, linking manufacturers and healthcare providers for compliant, high-quality products. Trusted advisor focused on innovation and patient care. If you are looking for custom-made silicone rubber products, feel free to ask me any questions.
Welcome to contact us
If you have any questions, please fill in the relevant information. Weare very willing to provide more information and a full range ofservices for both you and your company
Welcome to contact us
If you have any questions, please fill in the relevant information. Weare very willing to provide more information and a full range ofservices for both you and your company
EXNAN
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