标准号：ISO 14971-2000
实施状态：作废
中文名称：医疗器械 对医疗器械风险管理的应用
英文名称：Medical devices - Application of risk management to medical devices
发布日期：2000-12
被替代标准：ISO 14971-2007
代替标准：ISO/FDIS 14971-2000;ISO 14971-1-1998
采用标准：DIN EN 1441-1998,MOD;DIN EN ISO 14971-2001,IDT;ANSI/AAMI/ISO 14971-2000,IDT;BS EN ISO 14971-2001,IDT;EN ISO 14971-2000,IDT;NF S99-211-2001,IDT;JIS T 14971-2003,IDT;JIS T 14971-2003,IDT;SN EN ISO 14971-2001,IDT;OENORM EN ISO 14971-2001,IDT;OENORM EN ISO 14971-2003,IDT;UNE-EN ISO 14971-2001,IDT;GOST R ISO 14971-2006,IDT
起草单位：ISO/TC 210
标准简介：This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical devices, estimate and evaluate the risks, control these risks and monitor the effectiveness of the control.
The requirements of this International Standard are applicable to all stages of the life cycle of a medical device.
This International Standard does not apply to clinical judgements relating to the use of a medical device.
It does not specify acceptable risk levels.
This International Standard does not require that the manufacturer has a formal quality system in place. However, risk management can be an integral part of a quality system (see, for example, Table G.1).
文件格式：PDF
文件大小：1.72MB
文件页数：50
（以上信息更新时间为：2019-11-23）
ISO 14971-2000 医疗器械 对医疗器械风险管理的应用.pdf
(1.72 MB)
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