Regulatories/Legal Basis

Since the RoHS has been adopted in 2002 a stepwise ban of environmental relevant substances has to be made in Europe. Meanwhile the RoHS has been adopted analogously by other countries. Over the time the RoHS has undergone even further extended preventions.

As for example the exemption for hazardous substances in medical devices which will be launched since July, 22 of 2014 was suspended. So far oxygen sensors even with lead containing Anodes are still exempted due to Annex IV of the recasted RoHS. This exemption however, can be cancelled through a resolution of the stakeholder value committee at every time. With it those are running the risk that will bring leaded sensors into the medical market after the effective date mentioned to be affected by the removal of the exemption which is fixed under Annex IV.

For any industrial application the removal of the exemption for oxygen sensors will take place in July 2017.
Only by a timely replacement of lead containing sensors manufactures can avert the risk being affected of an immediate cessation of previous exemptions.

Furthermore, in order to meet high environmental standards it is planned in 2015 to proof evidence of lead-free in terms of RoHS as being part of the conformity declaration of medical products.

IT Dr. Gambert GmbH .: Hinter dem Chor 21 .: 23966 Wismar .: Germany