If you think RoHS is in your rear-view mirror, think again. A significant electronics market is going to feel the impact of RoHS within the next few years and may be caught unprepared.
Medical devices will fall under the RoHS scope starting in 2014, according to Gary Nevison of Newark/element14. Medical devices have so far been exempt from RoHS because of the critical nature of the devices and the necessary use of hazardous materials such as lead to protect users from radiation.
Medical devices fall under its regulations in 2014 but the sale of non-compliant devices into the EU won't be halted until 2019.
The manufacture of medical devices is still a very tightly held business. It is highly regulated, and it is difficult to quality for the various approvals required by law. Medical electronics companies have also been slow to outsource manufacturing, preferring to retain quality control in-house. Now that medical falls under the RoHS, it is likely the industry will experience many of the same issues the broader electronics industry has in terms of interpreting and implementing RoHS.
Nevison noted of a recent meeting in Belgium:
- During the meeting it was confirmed that passenger lifts will be considered large-scale fixed installations and would therefore be excluded from the scope of the RoHS Recast. It was also recommended to exclude pipe organs and electric bicycles from scope in the future. However, petrol engine powered garden equipment and toys with secondary electrical functions are expected to fall within scope.
While no change to the definition of homogeneous material was deemed necessary further clarification was requested on both thin coatings and CrVI passivation coatings.
Medical equipment companies can continue to ask for exemptions to the rule.