Medical devices - Quality management - Medical device nomenclature data structure (First Revision) (ISO 15225:2010, IDT)
This Malaysian Standard 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.
This 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 standard are applicable to the development and maintenance of an international nomenclature for medical device identification.
This standard does not include the nomenclature itself, which is provided as a data file.
Published
• (none) / (none) / (none)
PDF
22/01/2021
29
NSC 18 - Medical Devices and Facilities for Healthcare
