Views: 0 Author: Site Editor Publish Time: 2022-11-01 Origin: Site
Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other types or related items that are directly or indirectly used in the human body, including required computer software.
Medical device classification, the state implements classified management of medical devices according to the degree of risk:
Ⅰ. Medical devices that are sufficient to ensure their safety and effectiveness through routine management
Such as surgical instruments (knives, scissors, forceps, forceps, hooks), scraping boards, medical X-ray films, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc.
Ⅱ. Medical devices whose safety and effectiveness should be controlled
Such as medical suture needles, blood pressure needles, thermometers, electrocardiographs, EEG machines, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasonic disinfection equipment, non-absorbable sutures, condoms, etc.
Ⅲ. Medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled
Such as implantable cardiac pacemakers, corneal contact lenses, intraocular lenses, ultra-saving tumor focusing knives, hemodialysis devices, implanted equipment, vascular stents, comprehensive anesthesia machines, dental implant materials, medical absorbable sutures, blood vessels Inner catheter, etc.
1. Visual inspection
2. Product size/weight check
3. Barcode Scanning Check
4. Assembly/Installation Inspection
5. Assembly Test
6. Full function test
7. Coating adhesion test
8. Color fastness inspection
9. Silkscreen Test
10. Transport drop test
11. Stability Test
12. High Voltage Test
13. Power-on inspection
14. Ground test
15. Functional or Input Power/Current Check
16. Power cord pull test
17. Internal workmanship and inspection of key components
13. Product drop test
14. Burn-in test
15. Disassembly test