Passive Medical Device Testing Laboratory

JJR Passive Medical Device testing laboratory, China

The JJR Passive Medical Device testing Laboratory in China focuses on medical devices that do not rely on electrical or other external energy sources. These include implants, interventional devices, surgical instruments, in vitro diagnostic (IVD) devices (partial), medical dressings, nursing instruments, dental materials, and more.

The center strictly adheres to regulatory requirements from major global markets such as China (NMPA), USA (FDA), EU (MDR/IVDR), and Japan (PMDA), as well as international and national standards including ISO, ASTM, and GB. We offer comprehensive testing services covering design validation, type testing, registration testing, and post-market surveillance.

With a deep understanding of the diversity and complexity of passive devices, we provide professional, efficient, and compliant testing solutions to accelerate product launch.

Comprehensive Testing Services Across the Lifecycle of Passive Medical Devices

Physical and Mechanical Performance Testing

Material Mechanical Properties:

Tensile, compression, bending, shear, creep, stress relaxation, fatigue, impact, hardness

(Universal testing machine, fatigue tester, impact tester, etc.)

Product Functionality:

Strength, stiffness, elasticity, wear resistance, flexural resistance, sharpness (surgical blades, needles), penetration force, sealing (catheters, packaging), connection strength, sliding performance, operating force

Dimensions and Tolerances:

Geometrical dimensions, form and position tolerance measurements (calipers, micrometers, optical microscopes, etc.)

Special Performances:

Spring function, valve performance, flow testing (liquid/gas), pressure testing (burst, leakage), torque testing, particle contamination, etc.

Chemical Performance Testing

Material Chemical Characterization:

Component analysis, additive identification, leachable/extractable studies (in cooperation with the Chemical Characterization Center)

Physicochemical Properties:

pH, heavy metals (Pb, Cd, Hg), residue on evaporation, reducing substances, UV absorbance, acidity/alkalinity, moisture content, ash residue

Stability:

Accelerated aging and real-time aging (to assess material performance over time)

Degradation Properties:

Degradation rate, analysis of degradation products (for absorbable materials)

Biological Evaluation

Based on the ISO 10993series, we offer:

1. Cytotoxicity

2. Irritation and sensitization

3. Systemic toxicity

4. Genotoxicity

5. Local effects after implantation

6. Hemocompatibility

(in collaboration with the Biological Evaluation Center)

Sterilization Validation & Residual Testing

1.Ethylene Oxide (EO)Sterilization Validation:

Half-cycle and full-cycle validation, EO residual testing

2.Radiation Sterilization Validation:

Gamma and E-beam

3.Moist Heat Sterilization Validation

4.Sterility Assurance Level (SAL) Testing

Packaging and Transport Validation

1.Package Integrity Testing:

Dye penetration, bubble emission, vacuum leak, etc.

2.Material Strength Testing:

Burst strength, seal strength

3.Aging Tests:

Accelerated and real-time aging of packaging

4.Transport Simulation:

Vibration, shock, drop, compression, temperature/humidity cycling

(based on YY/T 0681.15-2019)

Cleanroom & Clean Area Environmental Monitoring

1. Airborne particles

2. Viable airborne and surface microbes

3. Air velocity, differential pressure

4. Temperature and humidity

(in accordance with ISO 14644, GMP, etc.)

Device-Specific Standards Compliance Testing

For devices like infusion/blood transfusion sets, syringes, orthopedic implants, dental materials, surgical sutures, dressings, etc.

Representative standards include:

GB 8368, GB/T 15810, YY 0450.1, YY/T 0174, YY/T 0167, YY/T 0471, YY/T 0308

Regulatory Consultation and Registration Support

We provide support with:

1. Standard interpretation

2. Test strategy design

3. Report review

4. Preparation of registration documents (including test reports)

Key Standards Involved

General and Foundational Standards

1. ISO 13485: Medical devices – Quality management systems – Regulatory requirements

2. ISO 14971: Medical devices – Application of risk management

3. ISO 10993 / GB/T 16886 series: Biological evaluation of medical devices

4. ISO 11135 / ISO 11137 / ISO 17665: Sterilization of medical devices (EO, radiation, moist heat)

5. YY/T 0681 series: Packaging for terminally sterilized medical devices

6. YY/T 0681.1 / ASTM F1980: Accelerated aging guide for sterile barrier systems

7. YY/T 0681.15: Testing for transport packaging

Device-Specific Standards (Examples)

1.Surgical Instruments:

YY/T 0174 (scalpel blades), YY 0167 (non-absorbable sutures), YY 1116 (absorbable sutures), GB 18457 (stainless steel needles), GB/T 15811 (disposable syringes)

2.Dental Materials:

ISO 7405 (biocompatibility), ISO 4049 (resin-based materials), ISO 9917 (cements), ISO 6872 (ceramics)

3.Medical Catheters:

YY 0285.1 / ISO 10555 (intravascular catheters), GB 1962 / ISO 80369 (connectors), ASTM D6319 (extracorporeal blood circuits)

4.Dressings:

YY 0471 (water resistance), YY/T 0148 (moisture vapor transmission), EN 13726 (dressing test methods)

5.In Vitro Diagnostic (Passive):

ISO 18113 (label requirements), ISO 15223 (symbols)

6.Others:

ISO 1135 (infusion/blood transfusion sets), ISO 25539 (cardiovascular implants), ISO 7198 (vascular grafts)

World-Class Laboratory Environment & Equipment

The JJR Passive Medical Device Testing Center is equipped with state-of-the-art instrumentation and a strictly controlled laboratory environment:

Mechanical Performance Laboratory

1. Multi-channel electronic universal testing machines

2. High-frequency fatigue testers

3. Impact testers (pendulum/drop)

4. Torque testers

5. Hardness testers (Rockwell, Vickers, Shore)

6. Abrasion testers

7. Flexural testers

Physical Properties Laboratory

1. Precision measuring instruments (calipers, micrometers, height gauges, projectors, CMMs, optical profilometers)

2. Flow test systems (liquid/gas)

3. Pressure test systems (burst/leakage)

4. Seal integrity testers (vacuum decay, HVLD, dye penetration, etc.)

5. Particle contamination analyzers

6. Surface roughness testers

7. High-precision electronic balances

Chemical Analysis Laboratory (Basic Items)

1. pH meters, conductivity meters

2. UV-Vis spectrophotometers

3. Constant temperature and humidity chambers, drying ovens, muffle furnaces

4. Evaporation residue systems

5. Titration devices

Packaging and Transport Laboratory

1. Package seal strength testers (tensile machines)

2. Burst strength testers

3. Accelerated aging chambers (temperature/humidity)

4. Transport simulation systems (vibration, impact, drop)

Clean Environment Monitoring

1. Particle counters

2. Airborne microbial samplers

3. Anemometers, differential pressure gauges

4. Temperature and humidity recorders

Biological Sample Preparation Area

Compliant sample processing environment

Standardized Testing Environment

Constant temperature and humidity labs (e.g., 23 ± 1°C, 50 ± 5% RH) to ensure consistent test conditions