无菌加工医疗器械产品的风险管理研究摘要：随着我国当前社会快速发展，特别是人口老龄化比重增多，人们更加注重健康。在日常生活中接触医疗器械比重增加，作为这种与人体健康息息相关的设备，往往能够引起较大的关注的。社会公众需要隔年专业的医疗器械，无菌器械相比其他器械其更符合人们对健康和高质量医疗急切产品需求，因而也出生医疗器械企业在无菌加工领域的产品生产。部分医疗器械企业在无菌加工中容易因环境、设备、人员等因素引发产品生产风险，影响企业销售和口碑，由此，才有了对无菌加工医疗器械产品的风险管理研究。本文将会从无菌加工医疗器械产品风险管理基础层面入手，进一步分析无菌加工医疗器械产品风险管理现状和存在问题，最后给出符合无菌加工医疗器械产品发展的风险管理对策，希望能为无菌加工医疗器械产品提供今后制定风险管理的理论指导，促动我国医疗市场建立，进而促进国民经济稳步发展。另，希望本文的研究对其他地区无菌加工医疗器械风险管理也有理论参考价值。关键词：无菌加工；医疗器械产品；风险管理ABSTRACT: With the rapid development of our society, especially the increasing proportion of population aging, people pay more attention to health. In daily life, the proportion of contacting medical devices increases. As such equipment closely related to human health, it can often cause greater concern. The public needs professional medical devices every other year. Compared with other devices, sterile devices are more in line with people's urgent needs for health and high-quality medical products. Therefore, medical devices enterprises are also born in the field of sterile processing products. In aseptic processing, some medical device enterprises are prone to cause product production risks due to environment, equipment, personnel and other factors, which affect the sales and reputation of enterprises. Therefore, the risk management research of aseptic processing medical device products has been carried out. This paper will start with the basic level of risk management...
