EN-74
english
Technical information
E
EN-75
english
Technical information
E
IEC 60601-1:2005 Medical electrical equipment - Part 1: General
requirements for basic safety
•
IEC 60601-1-2 : 2007 Medical electrical equipment Electromagnetic
compatibility
•
ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical
validation of automated version
•
DIN EN ISO 10993-1:2009 Biological evaluation of medical devices
- Part 1: Evaluation and testing
•
Manufacturer:
UEBE Medical GmbH
Zum Ottersberg 9
97877 Wertheim
Germany
Technical inspection / calibration check
6.
Basically, a metrological inspection is recommended at intervals of 2 years.
However, professional users in Germany are obligated to comply with
the aforementioned according to “Regulation for Operators of Medical
Devices”.
This can be implemented either by UEBE Medical GmbH, an authority re-
sponsible for metrology, or authorised maintenance services. For this, please
observe your national provisions.
Upon request, responsible authorities or authorised maintenance
services receive a “Test instruction for metrological inspection” from the
manufacturer.
Important: No modifications, e.g. opening the unit (except to replace
the batteries) may be made to this unit without the manufacturer’s prior
permission.
