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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Original Message:
Sent: 06-Feb-2018 11:49
From: Rekha Janarthanan
Subject: CE marking and RoHS
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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