Applicable Standards; Technical Inspection / Calibration Check - uebe visocor OM50 Instructions For Use Manual

E
Technical information
5.

Applicable standards

• EN 1060-1 : 1995 + A2 : 2009 Non-invasive sphygmomanometers - Part 1: General requirements
• EN 1060-3 : 1997 + A2 : 2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-
mechanical blood pressure measuring systems
• 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
EN-60
6.

Technical inspection / calibration check

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 responsible 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.
E
Technical information
EN-61