ISO 14971: medical devices - application of risk management to medical devices
ISO 14971: medical devices - application of risk management to medical devices
复制标题
ISO 14971：医疗器械 - 风险管理在医疗器械中的应用
DOI：
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发表时间：
2018
期刊：
影响因子：
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通讯作者：
A. Coronato
中科院分区：
文献类型：
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作者：
A. Coronato
本文讨论了ISO 14971标准。ISO 14971是专门为医疗器械开发设计的风险管理国际标准。该标准旨在帮助制造商建立一个完整的风险管理过程，包括危害的识别，相关风险的评估和风险控制措施的实施。
The paper discussed the ISO 14971 standards. ISO 14971 is an international standard for risk management specifically devised for the development of medical devices. The standard is intended to help manufacturers to establish a full risk-management process that includes the identification of hazards, the assessment of the related risks, and the implementation of risk control measures.