Medical device product inspection

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Medical device product inspection

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 product inspection scope

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.

On-site inspection and inspection points of medical device products

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