Design Article
Reliability testing enables medical devices to meet RoHS lead-free mandates
Randy Schueller, PhD, and Cheryl Tulkoff
10/12/2011 11:17 PM EDT
The first Restriction of Hazardous Substance (RoHS) legislation out of Europe, in 2006, provided an exemption for medical electronics. However, a second version that modifies this exemption has been released. Medical devices will be covered as of 2014, in vitro diagnostic equipment as of 2016, and industrial monitoring and control instruments as of 2017. The importance of planning for lead-free products is evident, especially considering the high reliability requirements, long development, and product run times in the medical device field. Many products being developed today will be sold beyond 2014.
Fortunately, the medical electronics industry can benefit from experience gained by other industries that have eliminated lead over the past several years. There are difficulties and risks associated with this significant change, but they can be managed. Experience from the consumer electronics industry shows that it is important to dedicate resources to the lead-free transition effort and to support it from the top down within an organization. Some companies have also used the opportunity to implement other best practices, such as improved process control and more thorough reliability testing. Eliminating lead also provides the chance to clean house and remove old test procedures that are no longer relevant.
This article addresses the reliability testing aspects of a lead-free conversion and provides a foundation for developing a lead-free reliability test plan. It covers:
•Structure of qualification document
•Product levels and types
•Reliability test plan
•Reliability tests, including thermal cycle testing, mechanical shock and vibration testing (S&V), highly accelerated life testing (HALT), and corrosion testing
•Reliability audit
To read the article, click here.
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ndancer
10/19/2011 12:39 PM EDT
It's actually funny, this ... I just finished reading several complaints in an adjacent article about how much more reliable older (analog) devices were. And now, RoHS is mandating medical devices be compliant based on "Well, all the rest of the industry has figured out how to handle lead free."
Sorry, idiots. It's the consumer that has learned how to handle it. They just throw it away. That means, if a pacemaker fails due to a tin whisker, well, we just follow suit and throw it away - into the cemetery! That's what I call, "Progress by uninformed legislation."
Of course, maybe that's part of the plan - reduce medical costs by forcing the old and infirm to die because of planned obsolescence? I can think of no other reason they'd take this attitude.
I mean, of course, if they really cared about science, they could actually investigate it rather than legislate by pseudo-statistics.
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