scope:

This guideline applies to medical devices requiring maintenance and/or management [8; 11].

Purpose of the guideline

The present guideline provides the framework for the development and use of catalogues in the maintenance and management of medical devices. The catalogues are intended to support identification, classification, maintenance, and management in medical technology, and to allow transparency independent of the user, as well as comparability of data stocks. Users, device managers, and, in particular, maintenance personnel can refer to this guideline when planning a database system for maintenance and management, and the manufacturers of any such de¬ vice are given guidance on the compilation of their device documentations.

Part 1 of this guideline provides the framework and serves to define the terms needed.

Part 2 et seq. of this guideline go into details about those catalogues, the use of which is not restricted to just one user.