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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for three-dimensional data; ISO/IEC 15444-11:2007 Wireless; ISO/IEC 15444-12:2015 Part 12: ISO base media file format [Withdrawn, no replacement] ISO/IEC 15444-13:2008 An entry level JPEG 2000 encoder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.
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Commission Regulation (EC) No 1474/2007 of 13 December 2007 amending Regulation (EEC) No 1538/91 introducing detailed rules for implementing Council Regulation (EEC) No 1906/90 on certain marketing standards for poultrymeat: Image title: Author: www.legislation.gov.uk: Software used: FOP 1.0: Conversion program: Apache FOP Version 2.1 ...
Commission Regulation (EC) No 787/2007 of 4 July 2007 amending Commission Regulation (EC) No 474/2006 establishing the Community list of air carriers which are subject to an operating ban within the Community (Text with EEA relevance) Image title: Author: www.legislation.gov.uk: Software used: FOP 1.0: Conversion program: Apache FOP Version 2.1 ...
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 ]
PDF/UA (PDF/Universal Accessibility), [1] formally ISO 14289, is an International Organization for Standardization (ISO) standard for accessible PDF technology. A technical specification intended for developers implementing PDF writing and processing software, PDF/UA provides definitive terms and requirements for accessibility in PDF documents and applications. [2]