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ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
Commission Regulation (EC) No 1474/2007 of 13 December 2007 amending Regulation (EEC) No 1538/91 introducing detailed rules for implementing Council Regulation (EEC) No 1906/90 on certain marketing standards for poultrymeat: Image title: Author: www.legislation.gov.uk: Software used: FOP 1.0: Conversion program: Apache FOP Version 2.1 ...
ISO 21500, Guidance on Project Management, is an international standard developed by the International Organization for Standardization, or ISO starting in 2007 and released in 2012. It was intended to provide generic guidance, explain core principles and what constitutes good practice in project management. [ 1 ]
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.
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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ISO 24617-1:2009, ISO-TimeML is the International Organization for Standardization ISO/TC37 standard for time and event markup and annotation. [1] The scope is standardization of principles and methods relating to the annotation of temporal events in the contexts of electronic documentation and language.
ISO 14698-2 became available to the public in October 2003. ISO 14698-2 gives guidance on basic principles and methodological requirements for all microbiological data evaluation, and the estimation of biocontamination data obtained from sampling for viable particles in zones at risk, as specified by the system selected. This is not intended ...