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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!
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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 makes silicone biocompatible?
Time： 2025-02-19 14:00:24
Author： Guangdong Exnan Technology Co.,Ltd
Click：
The biocompatibility of silicones is primarily due to the molecular structure of dimethylsiloxane (Table 14.9) [29]. From a toxicological perspective, the dimethylsiloxane chain is non-cytotoxic. (Example: Silpuran medical adhesive tape with UV-curable silicone rubber adhesive coating, courtesy of Wacker Chemie AG.)
Q: What makes silicone biocompatible?
A: The biocompatibility of silicones is primarily due to the molecular structure of dimethylsiloxane (Table 14.9) [29]. From a toxicological perspective, the dimethylsiloxane chain is non-cytotoxic. (Example: Silpuran medical adhesive tape with UV-curable silicone rubber adhesive coating, courtesy of Wacker Chemie AG.)
Q: How do you ensure biocompatibility?
A: Ensuring biocompatibility involves three key steps:
1. Develop a Biological Evaluation Plan (BEP), which assesses the device and its materials, identifies potential risks, and recommends evaluations or tests to mitigate those risks.
2. Conduct device evaluation and testing.
3. Prepare a Biological Evaluation Report (BER).
Q: What is the medical grade silicone standard?
A: Medical grade silicone is specifically designed, manufactured, and purified to meet the stringent requirements of the healthcare industry. These products are produced under applicable GMP standards in facilities regulated directly or indirectly by the US FDA and are often supported by master access files.
Q: What are biocompatibility standards for medical devices?
A: The ISO 10993 matrix assists manufacturers in determining the necessary biological tests for their medical devices based on factors such as the device's nature, duration of body contact, and type of body contact. It is essential to note that regulatory agencies may have specific requirements.
Q: What defines medical grade silicone?
A: Medical grade silicone, classified as Class VI material, undergoes rigorous testing to ensure compliance with all required standards. It must be manufactured using proper medical silicone molding techniques, distinguishing it from food-grade silicone.
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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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