Kucharska-Jastrząbek Agnieszka, Chmal-Fudali Edyta, Rudnicka Daria, Kosińska Barbara
Institute of Security Technologies "MORATEX", Marii Sklodowskiej-Curie 3 Street, 90-505 Lodz, Poland.
Materials (Basel). 2023 Jul 31;16(15):5389. doi: 10.3390/ma16155389.
Medical devices intended for implantation must be, in accordance with the legal provisions in force in the European Union, sterile. The effect of sterilization on the structural and thermal properties of implants, made by 3D printing from biodegradable polylactide and hydroxyapatite in a proportion of 9/1 by weight, was evaluated. The implants were sterilized using three different methods, i.e., steam sterilization, ethylene oxide sterilization, and electron beam radiation sterilization. As a result of the assessment of the structural properties of the implants after sterilization, a change in the molecular weight of the raw material of the designed implants was found after each of the performed sterilization methods, while maintaining similar characteristics of the thermal properties and functional groups present.
根据欧盟现行法律规定,用于植入的医疗器械必须无菌。对由重量比为9/1的可生物降解聚丙交酯和羟基磷灰石通过3D打印制成的植入物进行了灭菌处理对其结构和热性能的影响评估。采用三种不同方法对植入物进行灭菌,即蒸汽灭菌、环氧乙烷灭菌和电子束辐射灭菌。在对灭菌后植入物的结构性能进行评估后发现,每种灭菌方法后设计植入物的原材料分子量均发生了变化,同时热性能和存在的官能团保持相似特征。