Case Study: XRF for RoHS Testing of Medical Devices

RoHS Testing Benefits

The cost of non-compliance with RoHS regulations can be huge. 

These regulations are now affecting medical device manufacturers and a case study by Oxford Instruments highlights how one organization utilized the X-Met series of Handheld XRF to improve quality control and limit RoHS related costs.

RoHS compliance became law in 2006, requiring organizations in several industries to begin considering their approach to hazardous substance testing.  Regulations have since expanded to several countries and even individual states in the USA (Proposition 65 from California).  Therefore, many manufacturers (and supply chains) must develop and maintain proper protocols to insure that they have proper due diligence and screening in place to avoid fines or worse.

Despite the medical device industry having an exemption until 2014, many healthcare organizations took a proactive approach.  One leader in the medical device industry, highlighted in this case study, took a proactive approach to insure its products met compliance regulations in order to maintain its reputation of providing clients with high quality products and eliminate questions as the requirement approached.

Their initial investigation had shown that the use of independent contract laboratories to perform testing was not an option.  This decision was based on the large number of samples that would need to be tested...the cost was prohibitively expenseive and the time to get results back (potentially over two weeks) was unacceptable as their inventory was non-shippable during that time.  A company spokesperson said "In our search for the instrument of choice for our operation, Handheld XRF was identified as a suitable method that offered the required analytical results with speed and ease of use."  After a thorough review of handheld x-ray fluorescence analyzers, the organization selected the popular X-Met series from Oxford Instruments.  Several factors influenced the decision but Oxford Instruments knowledge of the regulations and the systems overall performance stood out against the other options.

What is the new procedure the client adopted?
"Our X-Met portable XRF analyzer is used to screen incoming components, whether they are plastics or electronic components used in assembling products and auditing our supply chain in order to insure these demands are met", the company spokesperson noted.

The X-Met is used in its portable position to analyzer large parts such as injection molded plastic housings, stuffed printed circuit board assemblies, cables, etc as well as for on-site auditing of their supply chain around the world.  They also utilize the X-Met in the option bench-top stand when they need to look at small components like electronic connectors and individual components (read about the new camera option).  Using the stand insures operator safety and proper alignment of the smaller sample pieces.

RoHS Test Results by XRF AnalyzerOnce measurements are complete, the results are displayed using a simple pass/fail scheme where a customized range for acceptable tolerances can be pre-defined, allowing operators to quickly identify problematic samples.  Once all testing for a given lot is completed, the data can be exported to a customized report that serves as a final inspection report.  While not being a final referee, x-ray fluorescence does provide a reliable screening method for quick decision making with regards to immediatley passing good material, failling bad, or submitting borderline goods onto wet chemistry testing methods.  This process has greatly reduced the volume of wet chemistry testing which resulted in additional cost savings and freeing up the laboratory to concentrate on truly problematic samples.

The client highlighted here has seen multiple benefits from their investment in the X-Met7500 analyzer - most identifiable it the cost and time savings from not outsourcing their testing.  Looking at costs alone, sending out samples would average between $75 and $200 per sample and they estimate payback of the analyzer in less than one year based on the volume of samples that would require screening.  In addition to long-term cost savings, the client saves time because of the immediate results, can audit suppliers, and has the additional ability of alloy analysis provided by every X-Met Handheld XRF analyzer.

"We can say we are comfortable with the selection of the Oxford Instruments X-Met to meet our RoHS testing needs.  It has become an integral part of our daily program and operation, and has saved us time and money."

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