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Requirements of the US FDA for stainless steel materials

Stainless steel materials are extremely important metal materials widely used in medical devices and food processing industries. The US FDA has strict requirements for stainless steel materials, mainly concerning their material composition, surface treatment, oxide film, and microbiological cleanliness.

Firstly, the composition of stainless steel materials must comply with the FDA’s requirements and not contain harmful substances such as lead or cadmium. Additionally, the surface treatment of stainless steel materials must meet FDA standards, requiring the surface to be smooth, seamless, and free from burrs and any contaminants such as oil or iron particles.

The FDA considers stainless steel materials with a chromium (Cr) content greater than 16% to be Generally Recognized as Safe (GRAS) materials.

The Culinary Institute of America (CIA) also confirms that stainless steel with a chromium content greater than 16% is suitable for food contact in cooking applications. For stainless steel intended for cooking, the CIA requires it to meet the specific compositional requirements of the corresponding grade.

Furthermore, the International Stainless Steel Forum (ISSF) suggests that stainless steel must have a chromium content exceeding 10.5% to exhibit its stainless properties.

Secondly, the oxide film of stainless steel materials must also meet FDA standards, meaning it must possess sufficient corrosion resistance while not compromising the material’s mechanical properties.

Additionally, the microbiological cleanliness of stainless steel materials is crucial. They must effectively kill bacteria, viruses, and other microorganisms to ensure hygiene and safety during usage.