RoHS Approaches for Medical Device Electronics

When the RoHS directive went into effect in 2006, medical devices  and industrial control equipment  were given a temporary exemption due to a lack of replacements, low usage levels, and their critical importance to specific applications.

But the European Union parliament voted late last year to remove those exemptions. Experts say the bill could become law sometime next year. Most medical devices would be covered by RoHS regulations three years after the effective date of the new law under the terms of the EU bill. There would be a delayed effectiveness date for in-vitro medical devices (five years) and industrial monitoring and control equipment (six years).

Some experts say that China may mirror the EU directive with its own regulations.

There was chatter in the halls of MD&M West in Anaheim, CA, that many medical electronics OEMs are already investigating or launching RoHS compliant products for medical devices. One reason is that product approval and design cycles can be much longer in the medical market than in other areas, particularly telecommunications.

Another is that it’s costly to maintain, lead-free production lines for most applications and lead-containing lines for medical. Even though lead is inexpensive at around $1.20 per pound it may be a better economic route to go with alternatives for supply chain (inventory-related) issues.