Passive products related

1. Surface contact equipment

Electrodes, external prostheses, fixation bands, compression bandages, and various types of monitors, etc.

Contact lens, urinary catheter, intravaginal or digestive tract instruments (gastric tube, colonoscope, gastroscope), endotracheal intubation, bronchoscope, etc.

Used for dressings or nursing devices for ulcers, burns, granulation tissues, and closed dressings, etc.

2. External access equipment:

Blood transfusion, infusion set, extender, transfer device, etc.

Laparoscopy, arthroscopy, drainage system, dental filling materials, skin nails, etc.

Intravascular catheters, temporary pacing electrodes, diabetic devices, intravenous catheters and accessories, vascular absorbents, immunoadsorbents, etc.

3. Implanted devices:

Orthopedic nails, artificial joints, bone prostheses, bone cements and intraosseous devices, pacemakers, implantable implant devices, neuromuscular sensors and stimulators, artificial tendons, implants, artificial larynx, subperiosteal implants , Ligature clips, etc.

Pacemaker electrodes, artificial arteriovenous bag tubes, heart valves, artificial blood vessels, internal catheters and ventricular assist devices, etc.

Introduction

Huatongwei lab medical device testing business provides four aspects of business:1 material chemical characterization testing, 2 biocompatibility testing, 3 major animal experiments, 4 microbiology testing

The medical device testing items we provide are:

1. EMC electromagnetic compatibility for medical devices

2. ISO10993 biocompatibility full project (GB16886 biological evaluation)

3. Physical and chemical performance test

4. Bacterial endotoxin test

5. Packaging verification

6. Cleaning and disinfection verification

7. Wireless coexistence test

8. ROHS testing and certification

9. CFDA (NMPA domestic registration) CE European registration, FDA US registration, INMETRO Brazil registration, etc.

Standards