Gruber-Bzura Beata M
Zakład Biochemii I Biofarmaceutykow; Narodowy Instytut Lekow, Warszawa Polska.
Wiad Lek. 2017;70(5):977-981.
According to the Polish Ministry of Health decree, the medical devices and all raw materials used for their manufacturing are in force to be compatible with biological tissues, cells and body fluids regarding its clinical use. It is defined as biocompatibility. The scope of the methods proposed in the norm PN-EN ISO 10993-1 makes possible to get full preclinical characteristics of the medical device and allows to form the opinion about safety of it to the patients after its marketing. The test directed as the principal to make, independently on characteristics, kind, contact duration and clinical use of the device is cytotoxicity in vitro. This test defines the impact of the device on the cells through microscopic evaluation or through activities of the enzymes specific for living cells. Toxicity of the material to the cells may be reflected in: change of single cells or whole cell culture morphology, change of cellular metabolic activity, DNA damage or disadvantage of cell proliferation. Biocompatibility of the medical devices is one of the main elements considered in a risk management process at the stage of designing and manufacturing as well of the raw materials as the final product and the critical point in this matter is sterilization.
根据波兰卫生部的法令，用于制造医疗设备的所有医疗设备及其原材料在临床使用中必须与生物组织、细胞和体液相容。这被定义为生物相容性。标准PN-EN ISO 10993-1中提出的方法范围使得获得医疗设备的完整临床前特性成为可能，并允许在其上市后对患者形成关于其安全性的意见。作为主要测试的是体外细胞毒性，该测试独立于设备的特性、种类、接触持续时间和临床用途。该测试通过显微镜评估或通过活细胞特异性酶的活性来定义设备对细胞的影响。材料对细胞的毒性可能体现在：单细胞或全细胞培养形态的变化、细胞代谢活性的变化、DNA损伤或细胞增殖的不利影响。医疗设备的生物相容性是设计和制造阶段风险管理过程中考虑的主要因素之一，原材料和最终产品都是如此，而此事的关键点是灭菌。
