ISO13485认证 新版ISO13485认证标准修订的背景
发布时间: 2020-12-14 15:55 点击：
ISO13485认证 新版ISO13485认证标准修订的背景
Background of revision of ISO13485 certification standard
ISO13485标准的诞生是和医疗器械法规紧密联系、相伴而生的；ISO13485标准的发展必然也是和医疗器械法规紧密结合、相伴而行的。
The birth of ISO13485 standard is closely linked with medical device regulations, and the development of ISO13485 standard is bound to be closely combined with medical device regulations.
随着社会变革、经济发展、新一轮科技产业革命的兴起、全球市场一体化进程的提速，医疗器械产业的生产方式、营销模式正在改变，导致医疗器械产业链延伸和日趋复杂，公众对医疗器械安全有效提出了新的需求。
With social change, economic development, the rise of a new round of scientific and technological industry revolution, and the acceleration of global market integration, the production mode and marketing mode of medical device industry are changing, which leads to the extension and increasingly complex of the medical device industry chain, and the public puts forward new demands for the safety and effectiveness of medical devices.
因此ISO依据世界各国医疗器械法规的重大变化和调整、质量管理技术发展的实践、医疗器械产业发展的需要以及ISO13485标准用户调查的反馈意见，决定启动ISO13485标准的修订工作，以加强新版标准和医疗器械法规的兼容性，满足用户不断增长的需求和期望，实现ISO13485标准的价值。
Therefore, according to the major changes and adjustments of medical device regulations in the world, the practice of quality management technology development, the needs of medical device industry development and the feedback from users' survey of ISO13485 standard, ISO decided to start the revision of ISO13485 standard, so as to strengthen the compatibility between the new standard and medical device regulations, meet the growing needs and expectations of users, and realize iso134 85 standard value.
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