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EN ISO 15225:2000/A1:2004

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange - Amendment 1 (ISO 15225:2000/A1:2004)

General information

99.60 Withdrawal effective   May 1, 2010

CEN/CENELEC

CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

European Norm

01.040.11   Health care technology (Vocabularies) | 11.040.01   Medical equipment in general | 11.120.01   Pharmaceutics in general

Scope

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. NOTE: This European Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases utilizing the nomenclature system described herein.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
Legislation 98/79/EC
93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 15225:2000

NOW

WITHDRAWN
EN ISO 15225:2000/A1:2004
99.60 Withdrawal effective
May 1, 2010

REVISED BY

WITHDRAWN
EN ISO 15225:2010