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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.
Ensure patient safety with our premium products. Explore our catalog today!
What is the quality control process of medical devices?
Time： 2025-02-21 10:24:41
Author： Guangdong Exnan Technology Co.,Ltd
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A prevalent technique for manufacturing medical grade silicone is injection molding. This involves forcing liquid silicone into a heated chamber made of metal or plastic under high pressure. The method ensures the production of a robust and resilient product by uniformly distributing heat across the material.
Q: What is the quality control process of medical devices?
A: The quality control process begins with the examination of raw materials and components to verify they comply with predefined quality criteria. Any materials that do not meet these standards are detected and corrected. Throughout the manufacturing phase, rigorous oversight is applied to ensure every procedure aligns with the set protocols and benchmarks.
Q: How is medical grade silicone manufactured?
A: A prevalent technique for manufacturing medical grade silicone is injection molding. This involves forcing liquid silicone into a heated chamber made of metal or plastic under high pressure. The method ensures the production of a robust and resilient product by uniformly distributing heat across the material.
Q: What are the medical properties of silicone?
A: Silicone is favored in the medical device industry for its versatile properties, including durability, moldability through various techniques, a broad operational temperature range, resistance to chemicals, high tensile strength, heat resistance, thermal stability, and a wide selection of hardness levels.
Q: Is medical grade silicone safe for the body?
A: Medical-Grade Silicone is a safe, non-toxic, and inert synthetic elastomer. It is subjected to biocompatibility tests to confirm its safety and stability when interacting with human tissues and bodily fluids.
Q: What is quality control in the production process?
A: Quality control (QC) refers to the systematic procedure of ensuring that manufactured products adhere to specific quality standards. These standards may be established internally, demanded by customers, or dictated by external bodies like the International Organization for Standardization (ISO).
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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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