Left image Global certified toxicologist, pathologist, experienced veterinary team
Left image 270,000+ biocompatibility studies
Left image Holistic competency testing, including in vivo, in vitro testing

In vivo tests

Irritation tests：

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 tests:

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

Systemic toxicity tests:

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

Sensitization tests:

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

Thrombosis test:

Test system: Beagle

In vitro tests

Cytotoxicity

MEM elution method

MTT method

Agarose overlay method

Direct contact

Neutral Red Method

Genotoxicity

Chromosomal aberrations

Ames Test

Mouse lymphoma test

Micronucleus test

Haemocompatibility

Complement activation

Haemolysis

Partial thromboplastin time measurement

Leukocyte and platelet counts

BIO New Business Introduction

In vitro Irritation test

n 2021, the International Organization for Standardization (ISO) issued a new standard for irritation tests, ISO 10993-23, which enriched and optimized the section on alternative in vitro tests for Irritation tests 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：
Grade Ⅱ and Ⅲ Devices
ISO 10993-23

Immunotoxicity test

ISO10993-20 and GB/T16886.20 provide guidances for potential immunotoxicity test of medical devices. Biological materials such as collagen, albumin and animal tissue are known to stimulate immune responses, so tests must be taken to demonstrate such materials non-immunogenic.  Medical devices, as exogenous substances, affect the body through a variety of ways after contact with human body, especially animal products, allogeneic products and tissue engineering medical products
Rats、Mice、In Vivo、In Vitro
Range：
China
Medical Device：
Animal derived Materials(bovine/pig derived heart valves, sheep intestinal sutures, collagen)  
ISO10993-20 and GB/T16886.20 provide guidances for potential immunotoxicity test of medical devices. Biological materials such as collagen, albumin and animal tissue are known to stimulate immune responses, so tests must be taken to demonstrate such materials non-immunogenic.  Medical devices, as exogenous substances, affect the body through a variety of ways after contact with human body, especially animal products, allogeneic products and tissue engineering medical products
Rats、Mice、In Vivo、In Vitro
Range：
China
Medical Device：
Animal derived Materials(bovine/pig derived heart valves, sheep intestinal sutures, collagen)  

Brain implantation test

Implantation test is a regular test for biocompatibility testing of medical devices, which is graded by comparing the difference of tissue reaction degree between test sample and negative control sample.  Brain tissue is the most important central nervous tissue in human body, and it is very risky for patients to contact the instruments of brain clinically.  Therefore, all medical devices in contact with brain and nerve tissue need to be evaluated by brain implantation test.  
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
Implantation test is a regular test for biocompatibility testing of medical devices, which is graded by comparing the difference of tissue reaction degree between test sample and negative control sample.  Brain tissue is the most important central nervous tissue in human body, and it is very risky for patients to contact the instruments of brain clinically.  Therefore, all medical devices in contact with brain and nerve tissue need to be evaluated by brain implantation test.  

Brain implantation test

ISO 10993-6
Devices with animals tissue
virus plaque

Virus inactivation validation

The use of animal tissue makes medical devices have better performance, but on the other hand, their use in humans will increase the safety risk of virus transmission.   If the existing production process cannot meet the requirements for virus inactivation/removal, additional appropriate virus inactivation/removal steps should be added.
Range：
Global
Medical Devices：
Brain implant devices (brain implant electrodes, hydrocephalus shunt)
Guideline

Guidelines for technical Review of registration of medical devices of animal origin

Medical Devices Containing Materials Derived from Animal Sources Guidance

Guidelines for review of validation techniques for virus inactivation of allogeneic implantable medical devices  

Technical methods and guidelines for verification of virus removal/inactivation from blood products

VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN

To learn more about medical machinery testing, please contact us