1. Related to active products
Multi-parameter monitors, ultrasonic diagnostic equipment, infusion pumps and infusion controllers, clinical thermometers, non-invasive blood pressure monitoring equipment, pulse photoelectric oximeter equipment, high-frequency electrosurgery equipment, nerve and muscle stimulators, endoscopes, EEG Machines, surgery, cosmetics, diagnosis and treatment laser equipment, electrocardiogram diagnostic equipment, etc., clinical chemistry analysis equipment, immunochemical analysis equipment, automatic blood analysis equipment, microbial analysis equipment, automatic protein analyzer, biochemical analyzer, blood cell analyzer, Blood gas analyzer, chemiluminescence immunoassay analyzer, urine sediment analyzer, hemagglutination analyzer, automatic blood rheometer, automatic internal bacterial culture analyzer, microbial identification and bacterial susceptibility analyzer, nucleic acid purification instrument, blood tissue culture instrument, Frozen microtome, biological tissue dehydrator, tissue embedding machine, centrifuge, mixer, dyeing machine, high temperature pulse vacuum sterilizer, high temperature steam sterilizer, infrared electric sterilizer, high temperature disinfection cleaning machine, biological safety cabinet, etc.
2. 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.
1. EMC electromagnetic compatibility
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.
|
NO. |
Project |
Standard |
|
1 |
In vitro cytotoxicity test |
ISO10993-5，GB16886.5 |
|
2 |
Sensitization test |
ISO10993-10，GB16886.10 |
|
3 |
Skin, intradermal, oral mucosa irritation test |
ISO10993-10，GB16886.10 |
|
4 |
Stimulus test |
ISO10993-23 |
|
5 |
Acute systemic toxicity test |
ISO10993-11，GB16886.11 |
|
6 |
Subacute systemic toxicity test |
ISO10993-11，GB16886.11 |
|
7 |
Subchronic systemic toxicity test |
ISO10993-11，GB16886.11 |
|
8 |
Chronic systemic toxicity test |
ISO10993-11，GB16886.11 |
|
9 |
Heat source test |
ISO10993-11，GB16886.11 |
|
10 |
Chromosome aberration test |
ISO10993-3，GB16886.3 |
|
11 |
Micronucleus test |
ISO10993-3，GB16886.3 |
|
12 |
Gene mutation test |
ISO10993-3，GB16886.3 |
|
13 |
Ames test |
ISO10993-3，GB16886.3 |
|
14 |
Thrombosis test |
ISO10993-4，GB16886.4 |
|
15 |
Coagulation test |
ISO10993-4，GB16886.4 |
|
16 |
Platelet adhesion test |
ISO10993-4，GB16886.4 |
|
17 |
Complement activation test |
ISO10993-4，GB16886.4 |
|
18 |
Hemolysis test |
ISO10993-4，GB16886.4 |
|
19 |
Muscle implant test |
ISO10993-6，GB16886.6 |
|
20 |
Subcutaneous implantation test |
ISO10993-6，GB16886.6 |
|
21 |
Bone implantation test |
ISO10993-6，GB16886.6 |
|
22 |
Material characteristics analysis |
ISO10993-18 |
|
… |
… |
… |
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