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ISO 15225:2016 specifies 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, healthcare providers and end users. ISO 15225:2016 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 this International Standard are applicable to the development and maintenance of an international nomenclature for medical device identification. ISO 15225:2016 does not include the nomenclature itself, which is provided as a separate data file.
SN EN ISO 15225:2016
2016 10 01
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
Norm
SN EN ISO 15225:2010
2010 08 01
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
Norm
SN EN ISO 15225/A2:2005
2005 09 01
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regula...
Norm
SN EN ISO 15225/A1:2004
2004 05 01
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regula...
Norm
SN EN ISO 15225:2000
2000 04 01
Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regula...
Norm
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