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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.
4 Notes. 5 References. 6 External links. ... Download as PDF; Printable version; In other projects ... ISO 1 – ISO 1999; ISO 2000 – ISO 2999;
Geometrical Product Specification and Verification (GPS&V) [1] is a set of ISO standards developed by ISO Technical Committee 213. [2] The aim of those standards is to develop a common language to specify macro geometry (size, form, orientation, location) and micro-geometry (surface texture) of products or parts of products so that the language can be used consistently worldwide.
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 ...
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]
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.
IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not address clinical decision-making related to use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
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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