medical devices) Passiv e medic al device parison items 1. Basic principle 2. position 3. Manufacturing technology 4. Manufacturing material(such as material grade, animal derived materials, allograft material, ingredients, medicine ingredients, bioactive substances ,implemented standards and so on) 5.Performance requirements 6. Safety appraisal(such as patibility ,bio-safety and so on) 7. Implemented national/professional standards of the product 8.Application scope: (1)Applicable people (2)Applicable parts (3) Contact manner with human body (4)Indications (5)Applicable disease stage and level (6)Application environment 9.Use method 10. Contraindications 11.Prevention measures and warning 12.Delivery status 13. Sterilization/disinfection Method 14.Package 15.Label 16 Product instructions
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