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Legal Requirements

  • Inspection and CE marking

    Each manufacturer of laboratory instruments and medical devices bear a heavy responsibility for its products. These have to comply with legal requirements and EU regulations.

    The products under the labels Q. Instruments and BioShake be developed and produced according to applicable European directives and requirements in conformity with legal provisions, such as the WEEE/RoHS2 directive and product safety law (GPSG).

    The sign GS (tested safety) and CE (Conformité Européenne) are the only statutory marks in Europe for product safety.

  • CE Declaration of Conformity

    BioShake devices meet the basic health and safety requirements and applicable standards of:

    • EMC Directive 2004/108/EC
    • Low Voltage Directive 2006/95/EC
    • DIN EN 61010-1:2002-08 + B1:2002-11 + B2:2004-11
    • DIN EN 61010-2-010:2004-06
    • DIN EN 61010-2-051:2004-07
    • EN 61326-1:2006