Accredited Medical Device Testing Lab

Active Products Related

Multi-parameter monitors, ultrasound diagnostic equipment, infusion pumps and controllers, thermometers, non-invasive blood pressure monitoring equipment, pulse oximeters, high-frequency electrosurgical devices, nerve and muscle stimulators, endoscopes, electroencephalographs, surgical, cosmetic, diagnostic, and therapeutic laser devices, electrocardiograph diagnostic equipment, clinical chemical analyzers, immunochemical analyzers, fully automatic blood analyzers, microbiological analyzers, fully automatic protein analyzers, biochemical analyzers, blood cell analyzers, blood gas analyzers, chemiluminescent immunoassay analyzers, urine sediment analyzers, coagulation analyzers, fully automatic blood rheology analyzers, fully automatic bacterial culture analyzers, microbiological identification and bacterial susceptibility testing analyzers, nucleic acid purification instruments, blood tissue culture instruments, cryostat machines, biological tissue dehydration machines, tissue embedding machines, centrifuges, mixers, staining machines, high-temperature pulsating vacuum sterilizers, high-temperature steam sterilizers, infrared electric sterilizers, high-temperature disinfection cleaning machines, biological safety cabinets, and more.

Passive Products Related

1. Surface Contact Devices

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

Contact lenses, urinary catheters, vaginal or digestive tract instruments (gastric tubes, colonoscopes, gastroscopes), tracheal intubation tubes, bronchoscopes, etc.

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

2. External Access Devices

Blood transfusion, infusion devices, extension tubes, transfer devices, etc.

Laparoscopes, joint endoscopes, drainage systems, dental filling materials, skin staples, etc.

Intravenous catheters, temporary pacing electrodes, dialysis machines, dialysis tubing and accessories, vascular adsorbents, immunoadsorbents, etc.

3. Implantable Devices

Orthopedic pins, artificial joints, bone prosthetics, bone cements, and internal bone devices, pacemakers, implantable drug delivery devices, neuro-muscular sensors and stimulators, artificial tendons, breast implants, artificial larynx, subperiosteal implants, ligating clips, etc.

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

4. In Vitro Diagnostic Reagents (Medical Testing Reagents)

Medical Device Testing Introduction

Medical devices are closely related to human health and safety, and related issues have become a focal point for both manufacturers and consumers. JJR Laboratory is a third-party laboratory in China engaged in testing active medical devices, providing long-term medical product testing services to domestic and international medical device manufacturers.

1. Testing Projects

Routine Safety Testing:

Temperature rise, dielectric strength, leakage current, defibrillation protection testing, mechanical testing, single fault testing, etc.

Electromagnetic Compatibility Testing:

Power terminal disturbance voltage, radiation disturbance, harmonic current, voltage fluctuation and flicker, electrostatic discharge immunity, radiofrequency radiation immunity, power frequency magnetic field immunity, electrical fast transient/burst immunity, RF conducted immunity, surge immunity, voltage dips, short interruptions, and voltage variations immunity.

Product-Specific Standard Testing:

For example: blood pressure accuracy, blood oxygen accuracy, infusion pump and controller accuracy testing, as well as performance testing for monitoring, nerve, and muscle stimulators, etc.

Biocompatibility:

- In vitro cytotoxicity testing

- Salmonella Typhimurium reverse mutation test

- Sensitization testing

- Genotoxicity testing

- Thrombosis testing

- Skin irritation testing

- Intradermal irritation testing

- Coagulation testing

- Acute systemic toxicity testing

- Subacute systemic toxicity testing

- Platelet adhesion testing

- Complement activation testing

- Subchronic systemic toxicity testing

- Chronic systemic toxicity testing

- Muscle implantation testing

- Hemolysis testing

- Pyrogen testing

- Chromosome aberration testing

- Bone implantation testing

- Bone marrow micronucleus testing

- Material characterization analysis

- Subcutaneous implantation testing

Endotoxin, Packaging Verification, Cleaning & Sterilization Validation, Biological Safety Evaluation

Preclinical Functional Evaluation, Microbiological Testing, Virus Inactivation, Chemical Performance Testing

Medical Device Testing Standards

1. Active | EMC, Safety, Performance, Environment:

1. Medical Electrical Equipment Electromagnetic Compatibility Requirements

 Testing Standard (Method) Name and Number: IEC/EN 60601-1-2; YY0505

2. Medical Electrical Equipment Safety Requirements

 Testing Standard (Method) Name and Number: IEC/EN 60601-1; GB 9706.1

3. Medical Electrical Equipment for Home Healthcare

 Testing Standard (Method) Name and Number: IEC/EN 60601-1-11

4. High Frequency Electrosurgical Equipment and Accessories

 Testing Standard (Method) Name and Number: IEC/EN 60601-2-2; GB9706.4

5. Nerve and Muscle Stimulators

 Testing Standard (Method) Name and Number: IEC/EN 60601-2-10; YY0607

6. Infusion Pumps and Controllers

 Testing Standard (Method) Name and Number: IEC/EN 60601-2-24; GB9706.27

7. Electrocardiographs

 Testing Standard (Method) Name and Number: IEC/EN 60601-2-25; GB10793

8. Electrocardiographic Monitoring Equipment

 Testing Standard (Method) Name and Number: IEC/EN 60601-2-27; EC13; GB9706.25; YY1079

9. Automatic Oscillometric Blood Pressure Monitoring Equipment

 Testing Standard (Method) Name and Number: EN1060-1; EN1060-3; ISO 81060-1; IEC/EN 80601-2-30; YY0667; YY0670

10. Invasive Blood Pressure Monitoring Equipment

Testing Standard (Method) Name and Number: IEC 60601-2-34; YY0783

11. Heating Devices for Blankets, Cushions, and Mattresses

Testing Standard (Method) Name and Number: IEC/EN 80601-2-35; YY0834

12. Ultrasound Medical Diagnostic and Monitoring Equipment

Testing Standard (Method) Name and Number: IEC/EN 60601-2-37; GB9706.9

13. Electronic Muscle Stimulators and Evoked Response Devices

Testing Standard (Method) Name and Number: IEC/EN 60601-2-40

14. Surgical Tables

Testing Standard (Method) Name and Number: IEC/EN 60601-2-46; YY0570

15. Portable Electrocardiographic Systems

Testing Standard (Method) Name and Number: IEC/EN 60601-2-47; YY0885

16. Multifunctional Patient Monitoring Equipment

Testing Standard (Method) Name and Number: IEC 80601-2-49; IEC/EN 60601-2-49; YY0668

17. Medical Beds

Testing Standard (Method) Name and Number: IEC/EN 60601-2-52; YY0571

18. Dental Equipment

Testing Standard (Method) Name and Number: IEC/EN 60601-2-60

19. Medical Pulse Oximeter Equipment

Testing Standard (Method) Name and Number: ISO80601-2-61; YY0784

20. Hearing Aids and Systems

Testing Standard (Method) Name and Number: IEC/EN 60601-2-66

21. Body Temperature Monitoring Devices

Testing Standard (Method) Name and Number: EN12470-3; EN12470-4; EN12470-5; ISO80601-2-56; IEC/EN80601-2-59

22. Medical Supply Units (Overhead Bridges, Arms)

Testing Standard (Method) Name and Number: ISO11197

23. Environmental Requirements and Test Methods for Medical Electrical Equipment

Testing Standard (Method) Name and Number: GB/T14710

24. Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use

Testing Standard (Method) Name and Number: IEC/EN 61326-1; IEC/EN 61326-2-6; GB/T18268.1; GB/T18268.26

25. Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use

Testing Standard (Method) Name and Number: IEC/EN 61010-1; GB4793.1

26. Laboratory Diagnostic (IVD) Medical Equipment

Testing Standard (Method) Name and Number: IEC/EN 61010-2-101; YY 0648

27. Laboratory Equipment for Material Heating

Testing Standard (Method) Name and Number: IEC/EN 61010-2-010; GB 4793.6

2. Passive | Biocompatibility:

1. In vitro Cytotoxicity Testing

 Standard: ISO10993-5, GB16886.5

2. Sensitization Testing

 Standard: ISO10993-10, GB16886.10

3. Skin, Intradermal, Oral Mucosal Irritation Testing

 Standard: ISO10993-10, GB16886.10

4. Acute Systemic Toxicity Testing

 Standard: ISO10993-11, GB16886.11

5. Subacute Systemic Toxicity Testing

 Standard: ISO10993-11, GB16886.11

6. Chronic Systemic Toxicity Testing

 Standard: ISO10993-11, GB16886.11

7. Hemolysis Testing

 Standard: ISO10993-4, GB16886.4

8. Muscle Implantation Testing

 Standard: ISO10993-6, GB16886.6

9. Bone Implantation Testing

 Standard: ISO10993-6, GB16886.6

10. Chromosome Aberration Testing

Standard: ISO10993-3, GB16886.3

11. Blood Thrombosis Testing

Standard: ISO10993-4, GB16886.4

12. Platelet Adhesion Testing

Standard: ISO10993-4, GB16886.4

13. Complement Activation Testing

Standard: ISO10993-4, GB16886.4

Our Services for Medical Clients:

- Medical Device CFDA (NMPA) Registration, FDA (Listing, 510k), EU CE, Brazil ANVISA (INMETRO, ANATEL), Australia TGA, Canada CMACAS, UK ukca, and other national market access services.

- Consulting Services:

- Early-stage product R&D regulatory guidance

- Product technical requirements review services

- Clinical evaluations

- Factory setup

- Quality management system establishment

Other Services

Service Advantages:

- Professional medical device testing equipment

- Stable testing team

- Experienced medical device testing and certification engineers

- Maintaining good communication with organizations and consulting firms

JJR Laboratory Solutions:

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

Electromagnetic compatibility testing rectification solutions.

Preliminary testing of general and special product standards for domestic medical device registration.

Q&A

Q: How long does it take to test medical device products?

A: The testing period depends on the type of power supply and whether it involves special standards. The regular testing period ranges from 4 to 8 weeks.