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The third edition of ISO 14971 was published in December 2019 and supersedes the second edition of ISO 14971. [ 5 ] Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and review, and also specifies a procedure for review and monitoring during production and post-production.
ISO/IEC 15444-8:2007 Secure JPEG 2000; ISO/IEC 15444-9:2005 Interactivity tools, APIs and protocols; ISO/IEC 15444-10:2011 Extensions for three-dimensional data; ISO/IEC 15444-11:2007 Wireless; ISO/IEC 15444-12:2015 Part 12: ISO base media file format [Withdrawn, no replacement] ISO/IEC 15444-13:2008 An entry level JPEG 2000 encoder
The European version of the risk management standard was updated in 2009 and again in 2012 to refer to the Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) revision in 2007, as well as the In Vitro Medical Device Directive (IVDD). The requirements of EN 14971:2012 are nearly identical to ISO 14971:2007.
ISO/IEC 24824-1:2007 Fast infoset; ISO/IEC 24824-2:2006 Fast Web Services; ISO/IEC 24824-3:2008 Fast infoset security; ISO/TR 24971:2013 Medical devices – Guidance on the application of ISO 14971; ISO 24978:2009 Intelligent transport systems – ITS Safety and emergency messages using any available wireless media – Data registry procedures
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices . [ 1 ]
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There is a book published in 2013: LMF Lexical Markup Framework [14] which is entirely dedicated to LMF. The first chapter deals with the history of lexicon models, the second chapter is a formal presentation of the data model and the third one deals with the relation with the data categories of the ISO-DCR.
Created Date: 8/30/2012 4:52:52 PM
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related to: iso 14971 2007 free pdf version of textbooks english