CN EN

Product Testing

Applicable Products

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.

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

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

Others

For medical device biocompatibility testing, please contact our CCIC Huatongwei directly. The corresponding testing cost is sent to customers in the form of a quotation for reference. You can call us 400-963-0755 and select "Medical Dedicated Line". Leave a message, or add emain:peifeng.chen@szhtw.com.cn, I will arrange for a medical engineer to add your quotation


Our test cost quotation is 30% lower than that of overseas laboratories; [understand that the cost does not affect you in fact]

Consult Telephone Order