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X-ray Fluorescence Measurement For Medical Product Components

Medical Component users of commercial off the shelf components are faced with a potentially dangerous parts shortage. It is possible that electronics thought to contain a minimum percentage of tin lead specified for medical components will be mislabeled and replaced lead-free components. As a result, tin whiskers could occur resulting in dangerous consequences.

The EU Directives WEEE and RoHS drastically change the types of components supplied to many industries including electronic equipment, printed circuit boards and plastics. Those categories of electrical and electronic equipment that are exempt from WEEE and RoHS face an even tougher and more critical challenge. Long-term effects of lead free solder used in medical components are not known meaning without accurate reliability testing there is a concern regarding defects.

As of July 2006, the use of lead containing solders in some electronic and electrical equipment will be prohibited. Exempt from this ban are parts for medical products.

Since the medical product portion of the overall market for solder is quite small, many suppliers are converting their production lines to the manufacture of only lead free solder. As a result there are far fewer sources for the SnPb required by the medical component market that has for decades been the standard means of preventing tin whiskers. Without Sn/Pb solder, parts exposed to harsh environments such as high humidity, vibration, and temperature variation could short circuit causing critical failures.

How does one guarantee a critical part contains the required SnPb percentage?

Ensuring a critical part contains at least 3% lead or other alloying elements can be accomplished with X-ray fluorescence measurement instruments. A quick, reliable, and non-destructive method for critical component identification for SnPb has been developed by Fischer Technology. Using X-ray fluorescence combined with the state of the art Win FTM®6 Software components can be clearly identified. By using this method, one can avoid the risks that might result should a parts supplier change to lead-free solder while maintaining the same part number. In addition, XRF measurement eliminates the rist that mixed lots in which some parts contain the necessary lead while others are lead-free are shipped without being identified.

Our material analysis instruments FISCHERSCOPE® XDAL and XAN® help target components that are lead-free using X-ray fluorescence in many different fields of application. They provide an effective solution giving accurate levels of lead solder in products such as printed circuit boards and all electrical and electronic equipment. The instruments are easy to operate and safe. They provide fast, reliable, and easily readable results which can be obtained by operators with very little experience. If the part cointains the necessary percentage of lead, the part is immediately identified as passing.

A screeing process can be implemented to allieviate the risk of mixed lots. In addition, the Fischer X-ray fluorescence instruments are capable of identifying the contents of hazardous substances Pb, Hg, Cd, Cr, and Br described in the EU directives WEEE and RoHS. A high resolution video camara is included in the measuring instrument. This optical system, together with some variable collimators which control the X-ray beam, enables the analysis of the smallest specimen. The XDAL® instrument provides an extremely easy and user-friendly way to enable automatic measurements of specimens on a large scale. Apart from screening of the part, the XRF also enables an accurate quantitative analysis.

For additional information contact Fischer Technology at 860-683-0781 or visit online at www.fischer-techology.com info@fischer-technology.com