Our Biocompatibility Testing Expertise

Left image Global certified toxicologist, pathologist, experienced veterinary team
Left image 270,000+ biocompatibility studies
Left image Full-scale in vivo & in vitro testing capacities

In Vivo Testing

Irritation test：

Intracutaneous reactivity test, Skin irritation test, Vaginal Irritation Test, Rectal Irritation Test, Oral Mucosa Irritation Test Test system: Rabbit, Syrian hamsters

Pyrogen test:

Chinese Pharmacopoeia, US Pharmacopoeia, Test system: Rabbit

Implantation test:

Subcutaneous implantation, Intramuscular implantation, Bone implantation, Test system: Rabbit, Rat

Systemic toxicity test:

Acute, Sub-acute, Sub-chronic, Chronic test system: Rat, Rabbit

Sensitization test:

Guinea pig maximization sensitization test (GPMT)., Closed-patch test (Buehler test) Test system: Guinea-pig

Thrombosis test:

Test system: Canine, Ovine, Swine

In Vitro Testing

Cytotoxicity

MEM Elution

MTT

Agarose Overlay

Direct Contact

Neutral Red Uptake

Genotoxicity

Chromosomal Aberration

Bacterial Reverse Mutation

Mouse Lymphoma Assay

Micronucleus Test

Hemocompatibility

Complement Activation

Hemolysis

Partial Thromboplastin Time (PTT)

Leukocyte and Platelet Counts

In Vitro Irritation Test

In 2021, the International Organization for Standardization (ISO) issued a new standard for irritation test, ISO 10993-23, which enriched and optimized the section on alternative in vitro test for irritation test based on ISO 10993-10.  SkinEthic™RHE is a 3D reconstruction epidermis model with organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The structure and functions of the model were very similar to those of human beings.  It has been validated by EURL ECVAM for determining skin irritation.
Range：
Europe CE generally
Medical Devices：
Class Ⅱ and Ⅲ Devices
ISO 10993-23

Immunotoxicity Test

ISO 10993-20 and GB/T 16886.20 provide guidance for evaluating the potential immunotoxicity test of medical devices. Biological materials, such as collagen, albumin, and animal tissues, are known to stimulate immune responses, so medical device biocompatibility testing is required to demonstrate that these materials are non-immunogenic. Medical devices, as exogenous substances, may affect the body through multiple ways after contact with human body, especially animal-derived products, allogeneic products, and tissue-engineered medical products.
Range：
China
Medical Device：
Animal derived Materials(bovine/pig derived heart valves, sheep intestinal sutures, collagen)  
ISO 10993-20 and GB/T 16886.20 provide guidance for evaluating the potential immunotoxicity test of medical devices. Biological materials, such as collagen, albumin, and animal tissues, are known to stimulate immune responses, so medical device biocompatibility testing is required to demonstrate that these materials are non-immunogenic. Medical devices, as exogenous substances, may affect the body through multiple ways after contact with human body, especially animal-derived products, allogeneic products, and tissue-engineered medical products.
Range：
China
Medical Device：
Animal derived Materials(bovine/pig derived heart valves, sheep intestinal sutures, collagen)  

Brain Implantation Test

The implantation test is a standard procedure in biocompatibility testing for medical devices, where tissue reaction differences between the test sample and the negative control sample are compared and graded. Brain tissue is the most important nervous tissue in the human body, and clinical contact with brain-related instruments presents significant risks for patients. Therefore, any medical devices that come into contact with brain or nerve tissue must undergo a comprehensive brain implantation test to ensure their safety and biocompatibility.
Range：
Global
Medical Devices：
Brain implant devices (brain implant electrodes, hydrocephalus shunt)
Stain and Biomarker Cell type or cellular component evaluated
Hematoxylin and eosin (H&E) All CNS and lymph node tissue
Fluoro-jade Degenerating neurons
Autofluorescence Neurodegeneration
Anti-glial fibrillary acidic protein (GFAP) antibody GFAP (astrocyte biomarker)
Anti-iba-1 antibody Ionized calcium binding adaptor molecule 1 (microglia-specific)
Luxol fast blue Myelin
The implantation test is a standard procedure in biocompatibility testing for medical devices, where tissue reaction differences between the test sample and the negative control sample are compared and graded. Brain tissue is the most important nervous tissue in the human body, and clinical contact with brain-related instruments presents significant risks for patients. Therefore, any medical devices that come into contact with brain or nerve tissue must undergo a comprehensive brain implantation test to ensure their safety and biocompatibility.

Brain Implantation Test

ISO 10993-6

To learn more about medical device testing, please contact us.