ISO13485新版标准在无菌医疗器械质量管理中的进展研究

The Research Process of the New Code ISO13485 on the Sterile Medical Device Quality Management

医疗器械产业事关人类生命健康,它交叉了多个不同的学科,是知识密集型的技术产业,它的发展水平体现了国家的综合实力,代表了科学技术的发展程度。随着全球市场发展的一体化,医疗器械产业蓬勃发展,它的生产形式、经营模式都在改变,供应链变得日趋冗长复杂。在这种情况下,各国的医疗器械监管部门对医疗器械的安全使用性及有效性越来越重视,医疗器械质量管理体系标准不断地更新,国际标准化组织发布了ISO13485:2016《医疗器械质量管理体系用于法规的要求》,在医疗器械的生产、经营过程中加强质量控制。

The medical device industry is a high technology industry that related to the health of human beings. It represents the comprehensive national power and the development of science and technology. With the process of global market integration, the medical device industry continues to thrive. The production and marketing model is changing, and the supply-chain is becoming more and more complex. In this situation, whether the medical devices are safe and effective causes the attention of regulators from all over the world, and the corresponding quality management system standards are constantly updated. The International Organization for Standardization issued ISO13485： ＂Medical devices Quality Management Systems Requirements for Regulatory Purposes＂ in 2016, which used to control the quality of medical devices products effectively.