Standard

NS-EN ISO 15225:2000

Withdrawn

Note: This standard has a new edition: NS-EN ISO 15225:2016

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Abstract

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 1: 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. The requirements contained in this standard are applicable to the development and maintenance of a European nomenclature for medical device identification. NOTE 2: This European Standard will not include the nomenclature itself. The nomenclature will be supplied as a separate document. NOTE 3: It is intended to complement the specific requirements of the EC Directives on medical devices in the context of specifying means by which common identification can be achieved between bodies required to exchange data in conformity with the requirements of the Directives.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 1
  • Version: 1
  • Document type: NAT
  • ICS 01.040.11
  • ICS 11.040.01
  • ICS 11.120.01
  • National Committee CEN/TC 257

Legal references

EU law: 98/79/EC, 93/42/EEC

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