Biocompatibility testing ensures that devices do not contain materials or substances that could be harmful to patients during initial use or over the course of time. Biocompatibility is an essential aspect of the medical device industry. Biocompatibility tests can be used to detect many possible negative side effects of a product on patient. These may include effects on cells and physiological systems, tissue irritation and inflammation, immunological and allergic reactions and the possibility of cellular mutations leading to cancer. According to the interpretation of the International Standards Organization (ISO) meeting, biocompatibility refers to the ability of living organisms to react to inactive materials, and generally refers to the compatibility between the material and the host. After the biomaterial is implanted in the human body, it will have an impact and effect on the specific biological tissue environment, and the biological tissue will also have an impact and effect on the biomaterial. The cyclic effect of the two continues until equilibrium is reached or the implant is removed. Biocompatibility is a theme that runs through in the research of biomaterials.
Biocompatibility simply refers to the properties of materials being biologically compatible but not eliciting local or systemic responses from a living system or tissue. From a regulatory stance, biocompatibility is a series of tests that are used to determine the potential toxicity resulting from contact of the components of medical devices or combination products with the body.
In fact, regulatory guidelines mandate that leachates of a device should not produce adverse local, systemic, tumorgenic, reproductive or developmental effects. Evaluations of biocompatibility, which are spelled out in ISO 10993, are all part of the overall safety and efficacy assessment of medical devices, including pacemakers, hip replacements and stents, and combination products like syringes, inhalers and patches.
Biocompatibility can be divided into two parts: biological reaction and material reaction. The biological reaction includes blood reaction, immune reaction and tissue reaction; material reaction is mainly manifested in the change of the physical and chemical properties of materials.
Biocompatibility is mainly determined by the nature and use of the material. The properties of materials and products themselves, including shape, size and surface roughness, residual toxic low-molecular substances during material polymerization or preparation, material processing pollution, material degradation products in the body, etc. are all related to their biocompatibility. The short-term contact between the material and the body will cause toxicity, irritation, teratogenicity and local inflammation to the cells and the whole body; long-term contact may have mutagenic, teratogenic and carcinogenic effects; contact with blood can cause abnormal blood coagulation and hemolysis. Therefore, when When considering the use of materials in the field of biomedicine, their biocompatibility is an important indicator that needs to be considered and evaluated.
The evaluation of the biocompatibility of materials follows the two principles of biosafety and biofunctionality, which not only requires biomaterials to have low toxicity, but also requires biomaterials to properly stimulate the body’s corresponding functions in specific applications. The evaluation of biocompatibility mainly refers to the requirements of International Standards Organization (ISO) 10993 and the national standard GB/T16886, through a series of in vitro and in vivo experiments.
The immune response and tissue repair process in the body are very complicated, and it is not enough to determine the biocompatibility of a certain material through a cell or tissue. To evaluate and analyze the biocompatibility of a certain material, three key points must be clarified: First, no material is completely inert; second, biocompatibility is a dynamic process, not static; Third, biocompatibility is not simply the nature of the material itself, but the result of the interaction between the material and the body environment.
1) Most of the biological test samples in the body and in vitro are extracted under the extraction conditions specified in the text, and the experiment is carried out
2) Directly implant materials and medical equipment into the body, and carry out experiments in contact with tissues, blood or body surface tissues and blood. The vast majority of in-body experiments are carried out through surgical aseptic operation methods.
3) Carry out in vitro cell culture, observe the cytotoxicity of samples, and determine the toxic effects of extracts or materials on cell lysis (cell death) and growth inhibition.
4) The carcinogen experiment involves implanting materials of different shapes, sizes, and surface conditions into a certain part of the body to observe the effects of materials and medical equipment on the body’s potential carcinogens during the entire life of the animal.
5) The blood compatibility test is to directly contact the blood through materials and medical equipment, firstly observe the coagulation effect on platelet activation and thrombosis, and secondly observe the effects of plasma protein, blood formed elements, complement system, and cytokine.
6) The implantation test is to embed biological materials and medical devices in certain parts of the animal body, and embed the materials for different time to change the local histopathology.
7) Degradation test is to use various in vivo and in vitro methods to measure the degree of degradation of materials and medical devices, changes in mechanical strength, to understand the absorption, distribution, and metabolism of degradation products in the body, and to evaluate the harmful effects of materials on the body.
The two major principles followed by biocompatibility testing are the biosafety principle and the biofunctional principle. The purpose of the biological safety principle is to eliminate the destructive effects of biological materials on human organs, such as cytotoxicity and carcinogenicity. Biological materials are foreign to the host and will inevitably produce some kind of response or rejection in the body. Therefore, biosafety evaluation of biological materials must be carried out to ensure that the materials are accepted by the host and do not produce harmful effects.
Supporting our biocompatibility testing program is an infrastructure built on years of being a leader in the industry and at the forefront of cutting-edge biocompatibility testing.
Regulatory Expertise: Industry-recognized experts who actively participate in regulatory committees and transfer that knowledge into program designs.
Customization Capabilities: Customizing of standard protocols to fit specific product development needs.
Experienced Technical Staff: In-house surgeons and veterinarians, highly trained technicians and the experience that comes from performing thousands of biocompatibility assays.
On-Site Ancillary Labs: Including histopathology and clinical pathology.
Operational Excellence: A sustained commitment to continual process improvement to ensure better performance and maximum flexibility.
There are many biocompatibility test items, mainly including cytotoxicity, sensitization, irritation, systemic toxicity (acute toxicity), subchronic toxicity (subacute toxicity), genetic toxicity, implantation, chronic toxicity, carcinogenicity, reproduction and development Toxicity and biodegradation, etc. Not all medical equipment products require a full set of test items. The industry only needs to search for items that match its own products based on the use characteristics of its own products, combined with the parts that touch the body and the length of time, and carry out judgments. In fact, for medical devices with low safety risks such as touching the body skin, mucous membranes and damaged surfaces, the three items that need to be tested are: in vitro cytotoxicity test, skin sensitization test, irritation test, also known as biology Three items are the basis of judgment. When the product is in contact with the body for a long time or when the risk of the touched part is high, the product needs additional subacute/chronic toxicity, genetic toxicity, implantation and other experiments.
Cytotoxicity
Irritation
Sensitization
Toxicity
Genetic Toxicology (Genetic Toxicology using Prokaryotics; Genetic Toxicology using Eukaryotics)
Hemocompatibility (In vitro assays, Biological endpoints)
Functional Implantation Studies
Local Tolerance
Non-Clinical Safety Test In Vivo
Physico-Chemical Tests
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