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EN ISO 14971:2012 Standard

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  Keywords:

#standard #international #devices #quality #system

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Thursday 15th 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

EN 14136:2004

In vitro diagnostic medical devices Directive (98/79/EC)

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

EN ISO 18113-2:2011

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EN ISO 11737-2:2020

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Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

EN 14820:2004

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Single-use containers for human venous blood specimen collection

EN ISO 14937:2009

In vitro diagnostic medical devices Directive (98/79/EC)

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

EN ISO 15193:2009

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and pre...

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