Biocompatibility test.
The most fundamental purpose of biocompatibility test is to verify the biological safety of medical devices that come into contact with or implant in the human body, mainly referring to the interaction between the material and the human body without toxicity to the human body, no sensitization, and no adverse reaction to the human immune system. After the biological material is implanted into the human body, it has an impact and effect on the specific biological tissue environment, and the biological tissue will also have an impact and effect on the biological material, and the cyclic effect of the two continues until equilibrium is reached or the implant is removed.
Biocompatibility can be divided into two parts: biological reaction and material reaction, in which biological reaction includes blood reaction, immune reaction and tissue reaction; Material reactions are mainly manifested in the change of 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, toxic low molecular substances left in the polymerization or preparation process of materials, pollution of material processing technology, and degradation products of materials in vivo are all related to their biocompatibility. Short-term contact between the material and the body will cause toxicity, irritation, teratogenicity and local inflammation to cells and the whole body; Long-term exposure may be mutagenic, teratogenic, and carcinogenic; Coagulation abnormalities and hemolysis caused by contact with blood, etc., so when considering the use of materials in the biomedical field, their biocompatibility is an important indicator to consider and evaluate.
1. Active products
Multi-parameter monitors, ultrasound diagnostic equipment, infusion pumps and infusion controllers, thermometers, non-invasive blood pressure testing equipment, pulsatile photoelectric oximeter equipment, high-frequency electrosurgical equipment, nerve and muscle stimulators, endoscopes, electroencephalogram machines, surgery, makeup, diagnosis and laser equipment, electrocardiogram diagnostic equipment, clinical chemistry analysis instruments, immunochemical analysis instruments, automatic blood analysis instruments, microbial analysis instruments, automatic protein analyzers, biochemical analyzers, blood cell analyzers, blood gas analyzers, Chemiluminescence immunoassay analyzer, urine sediment analyzer, blood coagulation instrument, automatic blood rheometer, automatic internal bacterial culture analyzer, microbial identification and bacterial susceptibility analyzer, nucleic acid purification instrument, blood tissue culture instrument, frozen microtome, biological tissue dehydrator, tissue embedding machine, centrifuge, mixer, dyeing machine, high temperature pulsating vacuum sterilizer, high temperature steam sterilizer, infrared electric sterilizer, high temperature disinfection cleaning machine, biological safety cabinet, etc.
2. Passive products
2.1. Surface contact equipment:
1) Electrodes, extracorporeal prostheses, fixation straps, compression bandages, and various types of monitors, etc.;
2) Contact lenses, urinary catheters, internal or digestive tract instruments (gastric tubes, colonoscopies, gastroscopes), endotracheal intubation, bronchoscopes, etc.;
3) Dressings or nursing instruments and occlusive dressings for ulcers, burns, granulation tissues, etc.
2.2. External access equipment
1) Blood transfusion, infusion set, extender, transfer device, etc.;
2) Laparoscopy, arthroscopy, drainage system, dental filling materials, nails, etc.;
3) Intravascular catheters, temporary pacing electrodes, dialyzers, dialysis tubing and accessories, vascular adsorbents, immunosorbents, etc.
2.3. Implanted devices
1) Orthopedic nails, artificial joints, bone prostheses, bone cement and intraosseous instruments, pacemakers, implantable drug delivery devices, neuromuscular sensors and stimulators, artificial tendons, breast implants, artificial larynx, subperiosteal implants, ligation clips, etc.;
2) Pacemaker electrodes, artificial arteriovenous fistulas, heart valves, artificial blood vessels, in vivo drug delivery catheters and ventricular assist devices, etc.