SR EN ISO 15225:2010

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)

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, which is provided as a data file.

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General information

Status : Withdrawn
Approval date : 10/31/2010
Withdrawal date : 9/30/2016
Number of pages : 28
ICS : 11.040.01 Medical equipmet in general,35.240.80 IT applications in health care technology
Technical Committee : 377 - Medical devices

Relations with other standards: