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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 ...
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.
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.
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]
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 ...
CC originated out of three standards: ITSEC – The European standard, developed in the early 1990s by France, Germany, the Netherlands and the UK. It too was a unification of earlier work, such as the two UK approaches (the CESG UK Evaluation Scheme aimed at the defence/intelligence market and the DTI Green Book aimed at commercial use), and was adopted by some other countries, e.g. Australia.
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 ]