Regulatory Open Forum

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  • 1.  CE marking and RoHS

    Posted 06-Feb-2018 11:49
    We are in the process of CE marking patient lifts. There are a lot of ideas about what components needs to meet RoHS compliance.

    Do we have to meet RoHS compliance for the tracks the lifts uses to move around in a room. Although there tracks don't contain any electronic components, it is still a part of a medical device system. 

    Any insights ?

    Thank you !

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    Rekha Janarthanan
    United States
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  • 2.  RE: CE marking and RoHS

    Posted 07-Feb-2018 05:32
    Rekha,

    From some of the applications of RoHS that I have seen many comment that you need to through the entire bill of materials for the device.  This can/should be done from a risk assessment perspective so base materials of components are reviewed and accepted as not falling under the requirements of the Directive.  As an example, many companies focus on electronic components or printed circuit boards, but who is to say some other metal component has some exotic (read restricted) material in it.  In your example of the rails, if is part of the system, would recommend including in your assessment according to RoHS.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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  • 3.  RE: CE marking and RoHS

    Posted 08-Feb-2018 11:18

    Dear Rekha,

    • RoHS applies to all Electrical and Electronic Equipment (EEE) that is sold in the EU.
    • Standalone items that are not part of an EEE device do not have to be RoHS complaint.
    • Standalone items that are part of an EEE device do have to be RoHS complaint.
    • Tools that are not sold to the customers and are used for the installation, repair, or testing are out of RoHS scope. In other words, do not have to be RoHS compliant.

    Non-electrical devices, with no current passing through them, do not have to be RoHS complaint

     

    Warm regards,

    Aurelia Brownridge

    Sr. Regulatory Affairs Specialist

    Tel: 858-291-6112

    Illumina, Inc.