T/HYBX 0002-2023 Far infrared therapeutic shoes

Scope

Scope: This standard specifies the technical requirements, test methods, conformity assessment, inspection rules, and marking, packaging, transportation, and storage for far-infrared physiotherapy shoes classified as Class II medical devices. Main technical content: 3. Principle of far-infrared physiotherapy shoes; 4. Technical requirements: 4.1 General requirements; 4.2 Marking; 4.3 Sensory quality; 4.4 Physical and chemical performance requirements; 4.5 Functional requirements; 4.6 Chemical limit substances; 5. Test methods: 5.1 Shoe last size; 5.2 Sensory quality; 5.3 Peel strength; 5.4 Folding resistance of finished shoes; 5.5 Wear resistance of outsole; 5.6 Adhesion strength between outsole and midsole; 5.7 Friction fastness of lining and insole; 5.8 Hardness of foamed outsole; 5.9 Anti-slip performance; 5.10 Antibacterial performance; 5.11 Far-infrared performance; 5.12 Magnetic performance; 5.13 Testing for the content of decomposable carcinogenic aromatic amines in textiles; 5.14 Testing for the content of free or partially hydrolyzable formaldehyde in textiles; 6. Result evaluation; 7. Inspection rules, marking, packaging, transportation, and storage.

Development Information

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