We use cookies to enhance your browsing experience, serve personalized content, and analyze our traffic. Cookies are small files of information stored on your device that help us remember your preferences and improve your experience. By clicking ‘Accept All’, you consent to our use of cookies. You are able to reject all non-essential cookies or manage your preferences by . To learn more about our Online Digital and Cookie Notice,
click here.
Cookie Preference Center
Please manage your cookie choices by switching the consent toggles on or off under the Purposes below.
You may change your preference at any time as described in our Cookie Policy
Nomenclature - Specification for a Nomenclature System for Medical Devices for the Purpose of Regulatory Data Exchange (Adopted ISO 15225:2000, first edition, 2000-09-15)
Publication Year 2001
Published by CSA Group
Withdrawn
info Login or Register
A free user account is required to view this document.
This document is purchased as a PDF (Portable Document Format) and accessed via CSA OnDemand™, where you can view, navigate, and print it, or download it for offline use with Adobe Acrobat Viewer. This PDF contains Digital Rights Management protection and is intended for individual use. Please see Terms of Use for CSA’s copyright license and more information.
Pages: 18
PDF
SKU: 2414282
This document is purchased as a PDF (Portable Document Format) and accessed via CSA OnDemand™, where you can view, navigate, and print it, or download it for offline use with Adobe Acrobat Viewer. This PDF contains Digital Rights Management protection and is intended for individual use. Please see Terms of Use for CSA’s copyright license and more information.
This European Standard specifies requirements and guidance for the 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 IC 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.
Login or Register
View Access for this document is only available for viewers in Canada