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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 International Organization for Standardization (ISO / ˈ aɪ s oʊ /; [3] French: Organisation internationale de normalisation; Russian: Международная организация по стандартизации) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member ...
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]
Download QR code; Print/export Download as PDF; Printable version; In other projects Wikimedia Commons; ... ISO 1 – ISO 1999; ISO 2000 – ISO 2999; ISO 3000 ...
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 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 ]
ISO 13849 is a safety standard which applies to parts of machinery control systems that are assigned to providing safety functions (called safety-related parts of a control system). [1] The standard is one of a group of sector-specific functional safety standards that were created to tailor the generic system reliability approaches, e.g., IEC ...
The first edition of ISO 20671 was published in March 2019. [ 6 ] in November 2021 the international standard has been renumbered in ISO 20671-1. AS International, headquartered in Vienna, have certified so far several brand evaluation agencies to ISO 20671 via its mandated ISO auditing entity.