医疗器械灭菌放行是生产环节的重要一部分,参数放行具有成本低、周期短的特点,风险前置能够最大程度保障医疗器械的无菌保证水平,但其实施过程中需要较高的设备配置、较强的技术能力、较高的生产质量管理水平等体系保障.通过引入智能制造系统,实现了环氧乙烷灭菌流程的全程智能化作业,显著提升了生产质量体系运行效果和灭菌生产的质量保证能力,达到参数放行的目的,并有效降低成本,对我国医疗器械监管逐步实施参数放行提供支持.

生物陶瓷因其生物相容性和力学稳定性而广泛应用于生物医学领域,但目前用于制造生物陶瓷产品的传统工艺较为耗时且成本昂贵.作为一种增材制造技术,三维(3D)打印更适合制备复杂形体.同时由于所需植入物形状各异,3D打印柔性化的特点为生物陶瓷植入物的制备提供了个性化定制的可能.综述陶瓷3D打印的材料、工艺及特点,阐述陶瓷3D打印研究现状及其在医疗领域的应用,阐述限制陶瓷3D打印技术发展与医疗领域中应用的瓶颈.

Objective To analyze the key links and technologies of medical dressing production, and to provide reference suggestions for the development and design of intelligent dressing manufacturing equipment and the optimization and upgrading of production line. Methods The key links included in the general production process of medical dressings were sorted out, and the key technology was analyzed from two aspects of the optimal design of the drying oven of the coating machine in the production of medical dressings and the intelligent control of tension in the coating assembly line. The characteristics of intelligent transformation were also analyzed. Results Dressing intelligent manufacturing production line scheme needs to focus on research and design:（1） The division of drying area. Dividing a drying tunnel into multiple drying areas can improve drying efficiency. According to different materials and drying processes, the optimal length of drying area can be selected to achieve the purpose of energy saving and emission reduction;（2） Real-time control of drying oven parameters, using simulation software to simulate the drying process to obtain the optimal drying temperature, air volume and return air ratio and other important control parameters, to solve the current control method relying on manual work, lack of scientific calculation and theoretical support;（3） The intelligent transformation of the tension control system should be targeted to improve the three main factors that produce tension: friction caused by transmission, torque of motor and linear speed difference between different motors. Conclusion The intelligent manufacturing of medical dressings can be upgraded from the aspects of coating drying system and tension control system. At the same time, the deployment of customized production execution system MES is also the development trend of intelligent manufacturing of dressings.