Tiêu chuẩn quốc tế
Số hiệu
Standard Number
EN ISO 14971:2012
Năm ban hành 2012
Publication date
Tình trạng
A - Còn hiệu lực
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Tên tiếng Anh
Title in English Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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Giá:
Price Liên hệ / Contact us
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Phạm vi áp dụng
Scope of standard This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. 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 decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
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