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      CN EN

      Product Testing

      Applicable Products

      Which products need to be tested for biocompatibility?

      Medical equipment products that have direct contact with the human body (dedicated for surgery and other medical products that indirectly contact the human body) such as scalpels, gauze, masks, protective clothing, dental instruments, etc.

      Introduction

      China Medical Equipment Biocompatibility Testing Laboratory"CCIC Shenzhen Huatongwei"is an authorised medical testing laboratory in China, providing ISO10993 testing for medical equipment&dental materials and other biocompatibility testing, such as cytotoxicity, sensitization testing, Skin irritation testing etc. Our company has a fully equipped biological laboratory, safety EMC laboratory, battery laboratory, radio frequency laboratory, etc.,  worldwide medical device manufacturers are welcome to submit testing application to our company, and the project time will be as fast as you need!

      Biocompatibility email: peifeng.chen@szhtw.com.cn

      Standards

      Biocompatibility evaluation can be classified according to the part of the medical device that contacts the human body (such as skin, mucous membrane, tissue, blood, etc.), method (direct, indirect contact or implantation), time (short-term, long-term and long-lasting) and use classification, general The evaluated biocompatibility test items are as follows.


      1. Cytotoxicity test

      This method is to directly contact the cells with the medical device materials, or add the material extract to the monolayer cultured cells to observe the toxic effects of the device, material and/or extract caused by cell lysis, cell growth inhibition and other toxic effects.

      2. Stimulus and delayed hypersensitivity test

      This test is used to evaluate the possible contact hazards caused by chemical substances released from medical devices, including skin and mucous membrane irritation, oral and eye irritation, and delayed-type contact hypersensitivity.

      Commonly used test animals are rabbits, guinea pigs and golden ground squirrels.

      3. Systemic toxicity test

      The material is doped with the extract, and the animal model is used for testing through a single route or multiple routes (venous, abdominal cavity).

      Mice are commonly used as test animals.

      4. Subchronic toxicity (subacute toxicity)

      Through a variety of methods, less than 10% of the life of the laboratory animal (for example, up to 90 days for rats), the harmful effects of the material are determined.

      Rabbits and rats are commonly used as test animals.

      5. Genotoxicity test

      The test includes bacterial gene mutation test, mammalian gene aberration test and mammalian gene mutation test.

      Use mammalian or non-mammalian cells, bacteria, yeasts or microorganisms to determine whether materials, instruments or extracts can cause genetic mutations, chromosomal structural aberrations, and other DNA or genetic changes.

      6. Implantation test

      The material is implanted into the appropriate part of the animal (such as muscle or bone), and after a period of observation, the local toxicity of the material on the living tissue is evaluated.

      Rabbits and rats are commonly used as test animals.

      7. Blood compatibility test

      Hemocompatibility is to evaluate the effect of materials on blood clot formation, plasma proteins, blood constituents and complement system by contacting materials with blood (in vivo or semi-in vivo).

      8. Chronic toxicity test

      Through a variety of ways, in most of the living body of more than experimental animals (for example, rats are usually 6 months), one or more exposures to medical devices, materials and/or extracts.

      Rats are commonly used as test animals.

      9. Carcinogenicity test

      Through a single approach or multiple approaches, the potential carcinogenic effects of medical devices can be determined throughout the life of the test animal.

      10. Reproductive and developmental toxicity test

      Evaluate the potential effects of medical devices or extracts on reproductive function, developmental development (teratogenicity), and early development of fetuses and infants.

      11. Biodegradation test

      This test is aimed at medical materials that may produce degradation products, such as polymers, ceramics, metals, and alloys, to determine their potential degradation products.

      12. Toxicokinetic research test

      Adopt GB/T16886.16 standard method.

      13. Immunotoxicity test

      According to the chemical properties of the device material, the original data of immunotoxicological effects, or the immunotoxicity test should be considered when the potential immunogenicity of the chemical is unknown.

      14. EO residue

      It is often caused by incomplete analysis or material adsorption. Refer to related standard methods of ISO10993, GB/T16886.

      Others

      Biocompatibility email: peifeng.chen@szhtw.com.cn
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