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New Standard - ISO 14971:2009?

Posted on December 15, 2011 in Articles

For those in the medical device industry, keeping up-to-date with standards for both product and system is essential for ensuring product compliance.  Have you heard about ISO 14971:2009?  If you wonder whether this is a new standard for risk management, you are only partly right.

First things first, ISO 14971:2007 Medical devices – Application of risk management to medical devices is the current standard in the ISO library.  There is no ISO 14971:2009 but there is a correction done to the ISO 14971:2007 on 1 Oct 2007 in which figure 1 was corrected.  Figure 1 is a schematic representation of the risk management process, whereby the left side arrow going back to the risk analysis process are from “risk control” and “production and post-production information” instead of “risk control” and “evaluation of overall residual risk acceptability”.

Secondly, the version 2009 is EN ISO 14971, the European version of the standard.  This standard is not available from ISO website but is available from the European national standards body such as BSI.

Thirdly, the difference between the EN ISO 14971:2009 and ISO 14971:2007 is in the first few pages, see below table which shows the content of the EN standard:

Cover page 


Approval of standard by CEN on 13 June 2009
Supersedes EN ISO 14971:2007
Published July 2009



This European standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2010, and conflicting national standards shall be withdrawn at the latest by March 2010.

For relationship with EU Directives, see information Annexes ZA, ZB and ZC, which are an integral part of this document.

Annex ZA

Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 
 Annex ZB
Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices
 Annex ZC
Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on In Vitro Diagnostic Devices
ISO14971:2007   The complete standard unchanged.

Fourthly, the content of ZA, ZB and ZC each contains five paragraphs and a warning.  Excerpts as follows:
This standard provides a process for managing risks associated with medical devices. 

Compliance with all the requirements clauses in this standard will ensure that general aspects of medical devices related to patient risk and safety have been addressed.

The risk management processes described in this standard could establish the need for collection of clinical or other experimental data for risk-benefit evaluation purposes.  It does not describe how this has to be carried out.  Relevant harmonized standards may be used for this purpose.

Warning – other requirements and other EU Directives may be applicable to a product falling within the scope of this standard.

Interested in discussing your requirements? Let’s talk.

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