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EN ISO 14971:2012 Standard

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  Keywords:

#standard #international #devices #quality #system

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Friday 17th of November 2017

  Description:

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

  Purpose

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.

  Publication

Friday 17th of November 2017

  Reference

This standard superseed the "EN ISO 14971:2009".

Anyway is still possible use the "EN ISO 14971:2009" until August 30th, 2012

  Related Standards

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EN ISO 11737-2:2009

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Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

EN ISO 13408-1:2015

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Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

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