Tuesday, 12 June 2012

Medical OEM's Need To Get RoHS Compliant By 2014

Since it was introduced by the EU in 2003, the Restriction Of Hazardous Substances (RoHS) has been overseeing the large quantities of toxic waste caused by electronics. It sets out regulations for the collection and recycling of electrical goods as well as the materials that can be used in electronics manufacturing.

On June 8th 2011, there was an amendment to the legislation known as RoHS 2.0. The new guidelines recognise the sum of the problems with the original legislation. The new guidelines addresses six substances used in electrical and electronic products manufacturing. They are Lead (Pb), Hexavalent Chromium (Cr6+), Mercury (Hg), Polybrominated Biphenyls (PBB), Cadmium (Cd) and Polybrominated Diphenyl Ethers (PBDE).

One important factor of the updated legislation is that it now covers medical devices as well as monitoring and control instruments. Manufacturers of these products now have to become compliant by the deadline of July 22nd 2014.

OEM's must become compliant with a number of new guidelines:
  • CE markings will be required on all products in order to demonstrate compliance with the new RoHS directive.
  • OEM's will need to produce documentation as proof that their CE marking has been achieved in compliance. For example, certificates of conformity for each component and material used in the manufacturing of the product could be used to demonstrate proof of compliance.
Due to the long time it takes to design and get approval in the medical manufacturing industry, it is the OEM's of Medical devices who are going to be the first affected by the new directive and therefore the ones who need to take action sooner rather than later.

For more detailed information on RoHS, please check out our Free Guide on How Major Manufacturers Denote RoHS Components.

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