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Hey there, I’m Steve!
I’m the sales manager of exnan medical silicone. I have been in this field for more than ten years. If you are looking for custom-made silicone rubber products, feel free to ask me any questions.
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Our certificate
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.
Class 10,000 cleanroom certification
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
Cooperating customers
Till now, Exnan products has been exports 35 countries, and more than 500 Medical equipment factory, health care companies, hospitals, clinics use our products, and win good reputation.
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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!
News
Our silicone accessories meet international medical standards through strict quality control.
Ensure patient safety with our premium products. Explore our catalog today!
What Makes Silicone Biocompatible?
Time： 2025-01-09 09:52:50
Author： Guangdong Exnan Technology Co.,Ltd
Click：
The biocompatibility of silicone is primarily due to its molecular structure, specifically the dimethylsiloxane chain (Table 14.9) [29]. From a toxicological perspective, the dimethylsiloxane chain is non-cytotoxic, meaning it does not harm living cells.
Q: What Makes Silicone Biocompatible?
A: The biocompatibility of silicone is primarily due to its molecular structure, specifically the dimethylsiloxane chain (Table 14.9) [29]. From a toxicological perspective, the dimethylsiloxane chain is non-cytotoxic, meaning it does not harm living cells.
Q: What is the Biocompatibility Standard for Medical Devices?
A: The ISO 10993 matrix is a crucial tool for manufacturers to determine the specific biological tests required for their medical devices. These tests are based on the device's nature, the duration of its contact with the body, and the type of body contact. It's important to note that different regulatory agencies may have their own distinct requirements.
Q: What is the 'Big Three' in Biocompatibility Testing of Medical Devices?
A: The 'Big Three' in biocompatibility testing refers to cytotoxicity, irritation, and sensitization testing. These three tests are essential for most medical devices, regardless of their category, patient contact, or duration of use (Lyons, 2022).
Q: Is 100% Medical Grade Silicone Safe?
A: Medical grade silicone is the purest form of silicone and is an industrially produced material. Due to its high purity, it is widely used in both the food and pharmaceutical industries. Medical grade silicone is 100% free from harmful ingredients such as BPA, PVC, and phthalates.
Q: What is the Best Biocompatible Material?
A: Here are 15 commonly used biocompatible materials:
1.Polypropylene (PP) (polymer)
2.Polytetrafluoroethylene (PTFE) (polymer)
3.Polymethylmethacrylate (PMMA) (polymer)
4.Stainless Steel (metal)
5.Trimethylcarbonate (TMC) (polymer)
6.TMC NAD-lactide (polymer)
7.Titanium & Titanium Alloys (metal)
8.Zirconia (ceramic biomaterial)
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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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