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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 15784-1:2008 Part 1: General principles and documentation framework of application profiles; ISO 15784-2:2015 Part 2: Centre to field device communications using SNMP; ISO 15784-3:2008 Part 3: Application profile-data exchange (AP-DATEX) ISO 15785:2002 Technical drawings – Symbolic presentation and indication of adhesive, fold and pressed ...
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 ...
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]
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 ]
The first step in hazard analysis is to identify the hazards. If an automobile is an object performing an activity such as driving over a bridge, and that bridge may become icy, then an icy bridge might be identified as a hazard.
ISO 10007 "Quality management — Guidelines for configuration management" is the ISO standard that gives guidance on the use of configuration management within an organization. [ 1 ] [ 2 ] "It is applicable to the support of products from concept to disposal ."
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