ISO 15225:2010 provides rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers, health care providers and end users.
ISO 15225:2010 includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases that utilize the nomenclature system described herein.
The requirements contained in ISO 15225:2010 are applicable to the development and maintenance of an international nomenclature for medical device identification.
ISO 15225:2010 does not include the nomenclature itself.
Document identifier
ISO 15225:2010
Title
Medical devices - Quality management - Medical device nomenclature data structure
ISO Category
TC 210: Quality management and corresponding general aspects for medical devices, TC 210/WG 3: Symbols and nomenclature for medical devices
Publication date
2010-05-01
International Relationship
BS EN ISO 15225:2010 * AAMI/ISO 15225:2010 * DIN EN ISO 15225
History of version
ISO 15225:2010 * ISO 15225:2000
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