99.60 Withdrawal effective Dec 20, 2017
CEN/CENELEC
CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices
European Norm
01.040.11 Health care technology (Vocabularies) | 01.040.35 Information technology (Vocabularies) | 11.040.01 Medical equipment in general | 35.240.80 IT applications in health care technology
Withdrawn
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.
WITHDRAWN
EN ISO 15225:2010
WITHDRAWN
EN ISO 15225:2016
99.60
Withdrawal effective
Dec 20, 2017
