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About This Item
Full Description
This European Standard specifies requirements and guidance for the construction of a nomenclature for medical devices in order to facilitate co-operation and exchange of regulatory data on an international level between interested parties such as: Regulatory Authorities, Manufacturers, Suppliers, Health Care Providers, and End Users.
The requirements contained in this standard are applicable to the development and maintenance of a European nomenclature for medical device identification.
Document History
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ISO 15225:2016
Medical devices - Quality management - Medical device nomenclature data structure- Most Recent
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ISO 15225:2010
Medical devices - Quality management - Medical device nomenclature data structure- Historical Version
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ISO 15225:2000
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Nomenclature -- Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange- Historical Version