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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.
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.
IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.
The ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01. [34] [35] The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971. ISO 13485:2016 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of ...
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 ]
A fix for this had been suggested to ISO/IEC JTC 1/SC 34/WG 4, and was approved in June 2009 as a recommendation for the first revision to Office Open XML. [ 34 ] Applications capable of reading documents compliant to ECMA-376 Edition 1 would regard ISO/IEC 29500-4 Transitional documents containing ISO 8601 dates as corrupt.
The Industry Foundation Classes (IFC) is a CAD data exchange data schema intended for description of architectural, building and construction industry data.. It is a platform-neutral, open data schema specification that is not controlled by a single vendor or group of vendors.
ISO/IEC/IEEE 29119 Software and systems engineering -- Software testing [1] is a series of five international standards for software testing. First developed in 2007 [ 2 ] and released in 2013, the standard "defines vocabulary, processes, documentation, techniques, and a process assessment model for testing that can be used within any software ...