◉ ISO 9001 (Quality Management System): Aether-Tex maintains the strict quality management process, ensuring consistent product performance, process control, and traceability across every stage of development and production.

◉ ISO 13485 (Quality Management System to Medical Device ): ISO 13485 certification demonstrates that Aether-Tex strictly adhere to the highest safety, hygiene and reliability standards required by the medical industry. Focusing on medical-grade TPU coating fabrics to meet the strict requirements for biocompatibility, easy cleaning, water resistance and durability.

◉ ISO 10993 (Biocompatibility Testing): Essential certification. As medical fabrics often come into contact with patients' skin, each Aether-Tex medical-grade TPU products has passed the corresponding tests in this series, including: cytotoxicity, sensitization and irritation experiments.

◉ REACH & RoHS (Chemical Safety Certification): Our medical-grade TPU coated fabrics fully comply with the strict requirements of REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances), two core international chemical safety certifications that ensure the safety and environmental friendliness of materials used in medical applications.

◉ OEKO-TEX Standard 100 (Ecological Textile Certification): For medical-grade TPU coated fabrics, Aether-Tex strictly adhere to the standard, which sets the limit values for the content of over 200 harmful substances (such as heavy metals, formaldehyde, perfluorinated compounds, etc.)

The products have passed the ISO 10993 biocompatibility certification with all levels of cytotoxicity, skin irritation and sensitization being 0, is sterile and resistant to repeated disinfection (high temperature / alcohol / ethylene oxide), has low allergenicity and no odor. Suitable for medical oxygen masks, medical gloves and isolation suits and other medical products that will come into direct contact with the human body.

Our medical-grade TPU fabric can be used for medical sterile fluid bags (infusion bags, blood bags, drainage bags), flexible transfusion tube and drainage tube sleeves. It features excellent chemical corrosion resistance, stain resistance and hydrolysis resistance, maintains stable performance in sterile medical scenarios, and has a long service life, fully meeting the strict requirements of medical fluid transmission and storage.

Medical fabrics require frequent disinfection with high-concentration alcohol, sodium hypochlorite (bleach), or quaternary ammonium salts. The TPU of Aether-Tex exhibits extremely strong resistance to disinfectants and hydrolysis, ensuring the fabric does not crack, peel, or become sticky after repeated disinfections.