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) EN ISO 15225:2000/A1:2004

General information

Current stage: 99.60 Withdrawal effective May 1, 2010

Originator: CEN/CENELEC

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

Type: European Norm

ICS: 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WITHDRAWN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WITHDRAWN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WITHDRAWN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