Is Your Medical Device RoHS Compliant?

By 22 July 2014 all medical devices must be compliant to the RoHS II legislative Directive (2011/65/EU). The key question is, are you ready? It may feel like the deadline crept up rather fast for some, but we’ve known since July 2011 when RoHS II was published. There has been plenty of time, but if you’ve only just started (or worse, done nothing) , it may not be as bad as you first thought.

The original RoHS I Directive (2002/95/EU) was published in February 2003 and came into force during June 2006. The original directive deliberately excluded medical devices, as it was recognized that banning the six substances might have an undesirable impact on reliability and durability. Problems in life-saving or -supporting medical devices would not have been tolerable. It was always understood that medical devices would be included with the scope once the consequences of changing to alternatives for the banned substances were better understood and the risks appreciated.

Medical device manufacturers can now make the switch to RoHS compliance more prepared than non-medical device manufacturers were 8 years ago. There is still an element of risk in change, but this risk may actually be quite small when one considers that many components in medical devices are already RoHS compliant. Products for the mass electronics market already RoHS compliant can make the process to become completely RoHS compliant less complicated than first thought.

For example, if one finds that the components on the BOM are RoHS compliant then the only thing that needs to be taken care of is the manufacturing technique. In the case of lead-free soldering, which requires approximately 40°C higher soldering temperatures, the concern in 2006 was that the higher temperatures would cause thermal stress on the components. If the components being used now are RoHS compliant, they already have the correct thermal properties. 

One of the most crucial components in a medical device is the power supply, which is in fact a collection of components in itself. As well as efficiently converting AC power to DC power the power supply is also the main safety isolation barrier. XP Power specializes in high-quality power conversion products for critical applications, such as medical devices, lasers, 3D printers, etc. A consequence of this approach was XP needed to fully embrace RoHS I directive in 2006 as virtually all the component suppliers were moving to RoHS components. If XP hadn’t switched then we would have been faced with higher component prices and in some cases obsolesce. Because of our proactive approach we were able to help our customers with the transition to RoHS I and we were in a position to deliver RoHS compliant power supplies in June 2006. The same can be said today, that XP has an extensive range of RoHS II complaint power supplies suitable for all sorts of medical devices.

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