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ISO 14971 Ed. 2.0 Edition 03/2007
Medical devices - Application of risk management to medical devices
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Abstract

ISO 14971:2007 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 ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

Status

Standard - Inactive

Origin

Technical Committee :
62A : Common aspects of electrical equipment used in medical practice

Implementation

start of the vote on the project      date of ratification (dor)   
end of the vote on the project      date of anouncement (doa)   
start of the vote on the final project      date of publication (dop)   
end of the vote on the final project      date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Evolutions
IEC 60947-2 Ed. 4.2
IEC 60947-2 Ed. 4.2
IEC 60947-2 Ed. 4.2
IEC 60947-2 Ed. 4.2
IEC 60947-2 Ed. 4.2
IEC 60947-2 Ed. 4.2

International Classification for Standards (ICS codes) :

11.040.01 : Medical equipment in general

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