ISO 15225:2016 PDF

Scope: This International Standard 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. This International Standard 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. This International Standard does not include the nomenclature itself, which is provided as a separate data file.

ISO 15225:2016 Referenced Document

IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

2016 ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
2010 ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
2004 ISO 15225:2000/Amd 1:2004 Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange; Amendment 1
2000 ISO 15225:2000 Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange