scope:

This guideline applies to all medical devices requiring maintenance and/or management. It can assist the users, consultants, and personnel in the management, and, in particular, in the maintenance of medical devices, in the planning of databases, and it can provide guidance to the manufacturers of medical devices in the compilation of their device documentations.

Purpose of the guideline

This guideline is intended to provide assistance in the identification, management, and maintenance of medical devices.

It is a basic requirement of the efficient maintenance and management of devices that the actual operation of a device is monitored as comprehensively as required, using a continuously updated database system. This database system shall not only allow data acquisition, but also, and in particular, the search for, and the evaluation of, the data stored. The most important aid here is the device catalogue listing all existing device categories. The designation of the product category/device category allows access to the data of all devices of any selected category (e.g. all "baby incubators"). However, such access is only ensured if the device designations entered in the device catalogue are unambiguous, and if the device designa¬ tions used in the master and dynamic data are identical with those in the catalogue. Any inaccuracy in cataloguing will make searches more difficult.

The Standardized Device Catalogue (SGK) is meant to replace the existing multitude of device catalogues. The unified application of the Standardized Device Catalogue is indispensable if device information is to be used by more than one user/company.