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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

Wednesday 14th of April 2021

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

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

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EN ISO 11137-1:2015

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EN ISO 11135-1:2007

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