This European Prestandard specifies the necessary requirements(clauses 5,6 and 7) for the categorical structure of systems of concepts for medical device groups(clause 4).This prestandard is meant to be used by organizations involves with the development or maintenance of nomenclatures and coding systems for medical devices, and by designers of databases or information systems involving medical device.
ENV 12611-1997由欧洲标准化委员会 IX-CEN 发布于 1997-04-01。
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