New BS EN ISO 14971 Medical devices. Application of risk management to medical devices Corregendum 1 for 2009 Edition

BS EN ISO 14971:2009 has been reissued with a new Corrigendum 1 as of February 2011.  The document is titled “Medical devices. Application of risk management to medical devices.”  It’s available for purchase from Document Center Inc.

The EN Corrigenda are corrections that are interfiled directly into the standard they modify.  For example, the Corrigendum 1 for  the BS EN ISO 14971:2009 corrects the pagination of the document.  So, there is no page within the document that describes the change.  It is just included by correcting the way the pages are numbered.

The EN ISO 14971 is a major European medical devices standard.  The BS EN ISO 14971 is the official English language edition.  It continues to adopt the ISO-14971:2007 Edition.

The 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 ISO 14971:2007 and its various adoptions are applicable to all stages of the life-cycle of a medical device.

The EN ISO 14971 is one of the “harmonised” standards for the Medical Devices Directive (93/42/eec), which means that by meeting the requirements of the standard there is the presumption of conformity with the essential requirements of the directive.

Both ISO 14971 and BS EN ISO 14971 are available for purchase from Document Center Inc.  Check out our website at www.document-center.com or send us an email at info@document-center.com, phone us at 650-591-7600 or send a fax to 650-591-7617.  We’re happy to help you with all your Standards Requirements.