How to Submit Samples for Biocompatibility Testing

Introduction

JJR in China has a comprehensive range of facilities, including a biomechanics laboratory, microscopy room, scanning electron microscopy (SEM) room, fatigue testing laboratory, in vitro simulation laboratory, packaging performance testing laboratory, chromatography laboratory, spectroscopy laboratory, aging room, biocompatibility laboratory, and microbiology laboratory. These facilities provide biomechanical analysis, pharmacokinetic analysis, material characterization, product performance testing, and accelerated shelf-life aging studies for medical devices and raw materials. Additionally, the laboratory offers biocompatibility testing for devices and materials, as well as microbiological testing.

Hardware Facilities

Infrastructure:

- Biomechanics Laboratory

- Microscopy Room

- Scanning Electron Microscopy Room

- Fatigue Testing Laboratory

- In Vitro Simulation Laboratory

- Packaging Performance Testing Laboratory

- Chromatography Laboratory

- Spectroscopy Laboratory

- Aging Room

- Blood Analysis Laboratory

- Biocompatibility Laboratory

- Microbiology Laboratory

Basic Equipment:

- Balloon catheter simulation push device

- Valve fatigue tester

- Vascular stent fatigue tester

- Filter fatigue tester

- Forward and steady-state flow leakage tester (thrombosis interception rate test)

- Universal testing machine

- Sealing tester

- Particle tester

- Metallographic microscope

- Hardness tester

- Torque tester

- Dissolution tester

- 3D microscope

- Non-contact optical measurement device

- Scanning electron microscope

- Energy spectrometer

- Micro-CT

- Gas chromatograph

- Intrinsic viscosity automatic tester

- High-performance liquid chromatography (HPLC)

- Gel permeation chromatography – multi-angle laser light scattering system

- Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

- Aging box

Blood Testing Equipment:

- Blood gas analyzer

- Hematology analyzer

- Urinalysis analyzer

- Biochemistry analyzer

- Coagulation analyzer

Pathological Sectioning and Analysis Equipment:

- Heavy-duty microtome

- Cryostat

- Automatic staining machine

- Embedding machine

- Digital pathology scanner

- Upright microscope

- Inverted microscope

Quality Assurance

The laboratory follows the ISO/IEC 17025:2017 and U.S. FDA GLP (21CFR Part 58) quality management systems. It has received accreditation from the China National Accreditation Service for Conformity Assessment (CNAS) and holds over 190 national-level CMA certifications in the medical device field.

Testing Service Cases

1. Biocompatibility Testing:  

Biocompatibility tests are conducted according to GB/T16886 and ISO10993 standards.  

- In vitro testing items: Coagulation test, platelet adhesion test, complement activation test, in vitro cytotoxicity test, Ames test, mouse lymphoma gene mutation test, in vitro mammalian cell chromosome aberration test, peripheral blood cell micronucleus test.  

- In vivo testing items: Sensitization reaction test, irritation reaction test, acute systemic toxicity test, subacute toxicity test, in vivo thrombosis formation test, pyrogen test, muscle implantation test.  

The laboratory selects appropriate biological test items based on the contact nature of materials in the final product according to the client's medical device intended use. It offers biocompatibility evaluation programs and final reports that comply with CE, CFDA, and FDA standards.

2. Pharmacokinetic Studies:  

Providing high-quality data and fast turnaround to support the development and preclinical studies of pharmaceutical drugs and drug-eluting medical devices. Pharmacokinetic studies can be conducted in animals (including mice, rabbits, dogs, pigs, etc.), analyzing drug distribution and pharmacokinetics through blood and tissue/organ samples collected at different time points. LC/MS/MS analysis is used to study drug absorption, distribution, metabolism, and excretion.

3. Biomechanics Testing:  

- Cardiac Implant System Performance (Vascular Stent System, Heart Occluder System): Compatibility testing, processing anastomotic strength, radial and axial compression resistance testing, bending resistance, knotting performance testing, in vitro preclinical simulation use testing (custom vascular models accepted), product fixation effectiveness testing, and fatigue durability testing.  

- Delivery System Performance (Delivery Catheter): Compatibility testing, Luer cone connector performance testing, processing anastomotic strength testing, in vitro preclinical simulation use testing (custom vascular models accepted), bending resistance; balloon catheter compliance, inflation/deflation time, burst pressure, torque binding strength, etc.  

Testing Standards:  

YY/T0663, ISO 25539, YY 0285, YY 0450, ISO 10555, YY/T 0858, ASTM F2606-08, YY 0500-2004, ISO 7198, B/T 1962, YY/T 0808, ASTM F 2477, etc.

4. Material Characterization:  

Polymer material composition analysis, metal material microstructure, surface morphology characterization, thermal analysis characterization.