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ILNAS-EN ISO 14971:2009 Edition 07/2009
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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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 - Active

Origin

Technical Committee :
CEN/CLC/TC 3 : Quality management and corresponding general aspects for medical devices

Directives

90/385/EEC : Active implantable medical devices
93/42/EEC : Medical devices
98/79/EC : In vitro diagnostic medical devices

Implementation

start of the vote on the project      date of ratification (dor)   
end of the vote on the project      date of anouncement (doa)    31/10/2009
start of the vote on the final project    12/02/2009   date of publication (dop)    31/01/2010
end of the vote on the final project    12/04/2009   date of withdrawal (dow)    21/03/2010


Publication Official Journal
of the Grand-Duchy of Luxembourg
14/03/2011
Reference Mémorial A N° 47

Relations

Evolutions
ILNAS-EN ISO 14971:2012

Relations to older standards
ILNAS-EN ISO 14971:2007
ILNAS-EN ISO 14971:2000/A1:2003
ILNAS-EN ISO 14971:2000

International Classification for Standards (ICS codes) :

11.040.01 : Medical equipment in general

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