Norma Uni En Iso 14971 Medical Devices
Norma Uni En Iso 14971 Medical Devices 2017
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Norma Uni En Iso 14971 Medical Devices Download
This Standard specifies a process for a manufacturer to identifythe hazards associated with medical devices, including invitro diagnostic (IVD) medical devices, to estimate andevaluate the associated risks, to control these risks, and tomonitor the effectiveness of the controls.The requirements of this Standard are applicable to all stagesof the life-cycle of a medical device.This Standard does not apply to clinical decision making.This Standard does not specify acceptable risk levels.This Standard does not require that the manufacturer have aquality management system in place. However, risk management can bean integral part of a quality management system.NOTE: The International Standard corresponding to this Standardand the symbol of degree of correspondence are as follows.ISO 14971: 2007 Medical devices-Application of riskmanagement to medical devices (IDT)In addition, symbols which denote the degree of correspondencein the contents between the relevant International Standard andJIS are IDT (identical), MOD (modified), and NEQ(not equivalent) according to ISO/IEC Guide21-1.Furthermore, JIS T 14971: 2003 is applicableuntil 28 February 2015.