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ISO 22745 Industrial automation systems and integration - Open technical dictionaries and their application to master data ISO 22745-2:2010 Part 2: Vocabulary; ISO/IEC TR 22767:2005 Information technology – Telecommunications and information exchange between systems – Using CSTA for SIP phone user agents (uaCSTA)
An example SDS, including guidance for handling a hazardous substance and information on its composition and properties. A safety data sheet (SDS), [1] material safety data sheet (MSDS), or product safety data sheet (PSDS) is a document that lists information relating to occupational safety and health for the use of various substances and products.
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
The process of using concept identifiers from an external open technical dictionary is a form of semantic encoding compliant with the requirements of ISO 8000-110:2008, the international standard for the exchange of quality master data. The eOTD concept identifiers are in the public domain.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
ISO 15223 Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied ISO 15223-1:2016 Part 1: General requirements; ISO 15223-2:2010 Part 2: Symbol development, selection and validation; ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information of a technical documentation for a medical device. ISO 13485 is a voluntary standard that contains section 7.3 Design and ...
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.