China Medical device Testing Lab

Which products are tested as medical devices?

1. Active product related

Multi-parameter monitors, ultrasonic diagnostic equipment, infusion pumps and infusion controllers, thermometers, non-invasive blood pressure monitoring equipment, pulse photoelectric oximeter equipment, high-frequency electrosurgery equipment, nerve and muscle stimulators, endoscopes, electroencephalogram machines, surgery, makeup, diagnostic and therapeutic laser equipment, electrocardiographic diagnostic equipment, etc., clinical chemistry analysis instruments, immunochemistry analysis instruments, fully automatic blood analysis instruments, microbiological analysis instruments, fully automatic protein analyzers, biochemical analyzers, blood cell analyzers, blood gas analyzers, chemiluminescent immunoassay analyzers, urine sediment analyzers, coagulation analyzers, fully automatic blood rheometers, fully automatic bacterial culture analyzers, microbial identification and bacterial drug sensitivity analyzers, nucleic acid purification instruments, blood tissue culture instruments, cryosectioning machines, biological tissue dehydrators, tissue embedding machines, centrifuges, mixers, staining machines, high-temperature pulsating vacuum sterilizers, high-temperature steam sterilizers, infrared electric sterilizers, high-temperature disinfection and cleaning machines, biological safety cabinets, etc.

2. Passive products related

1. Surface contact instruments

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

Contact lenses, urinary catheters, intravaginal or digestive tract instruments (gastric tubes, colonoscopes, gastroscopes), endotracheal tubes, bronchoscopes, etc.

Dressings or care devices and closed dressings for ulcers, burns, granulation tissue, etc.

2. External access equipment

Blood transfusion, infusion set, extension set, transfer set, etc.

Laparoscopes, arthroscopy, drainage systems, dental filling materials, skin staples, etc.

Intravascular catheters, temporary pacing electrodes, dialyzers, dialysis tubing and accessories, vascular adsorbents, immunoadsorbents, etc.

3. Implantation of the device

Orthopedic nails, artificial joints, bone prostheses, bone cement and intraosseous devices, pacemakers, implantable drug delivery devices, neuromuscular sensors and stimulators, artificial tendons, breast implants, artificial larynx, subperiosteal implants, ligature clips, etc.

Pacemaker electrodes, artificial arteriovenous fistulas, heart valves, artificial blood vessels, in vivo drug delivery catheters and ventricular assist devices, etc.

4. In vitro diagnostic reagents (medical test reagents )

Medical devices are related to human health and safety, and related issues have become the focus of common concern for manufacturers and consumers. Shenzhen Huatongwei is one of the earliest third-party laboratories engaged in active medical device testing in China, and has long provided medical product testing services to domestic and foreign medical device manufacturers.

1. Medical devices Test items 

General safety testing:

Temperature rise, withstand voltage, leakage current, defibrillation protection test, mechanical test, single fault test, etc.

Electromagnetic compatibility test:

Power terminal interference voltage, radiated interference, harmonic current, voltage fluctuation and flicker, electrostatic discharge immunity, radio frequency radiation immunity, power frequency magnetic field immunity, electrical fast transient pulse group immunity, radio frequency conducted immunity, surge immunity, voltage sag, short interruption and voltage variation immunity.

Product specific testing:

For example: blood pressure accuracy, blood oxygen accuracy, accuracy testing of infusion pumps and infusion controllers, as well as performance testing of a series of products such as monitoring, nerve and muscle stimulators, etc.

Biocompatibility Test:

Endotoxin physics,Packaging VerificationCleaning and disinfection validationBiosafety Assessment

Preclinical functional evaluation

Microbiological testing

Virus inactivation

Chemical performance testing

Medical device testing standards

1. Active | EMC, safety, performance, environment: 

2. Passive | Biocompatibility:

Our company can apply for medical customers:

Medical device CFDA (NMPA) registration, EU CE, Australia TGA, UK UKCA and other national access services;

1. Early product development regulations guidance
3. Clinical evaluation
5. Quality management system construction

1. Service advantages

Professional medical device testing equipment

Relatively stable testing team

Experienced medical device testing and certification engineers

Maintain good communication with institutions and consulting companies

2. China JJR Solution

Our product test reports are widely used in EU CE registration, US FDA registration and Brazil ANVISA registration.

Rectification plan for electromagnetic compatibility testing.

Basic test of domestic medical device registration and certification general standards and special product standards.

3. Q&A

Q: How long is the testing cycle of medical device products?

A: The product's different power supply types and whether it involves special standards determine the product's test cycle. The general test cycle ranges from 4 weeks to 8 weeks .

Other supplements for medical device testing and certification :

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