Dave, Ed, and others: The link I got from the NASA website and it is indeed broken. I found an article I'd downloaded from NASA that referenced this link which does work http://www.fda.gov/ICECI/Inspections/InspectionGuides/InspectionTechnicalGuides/ucm072921.htm Here are some details from the report: I am continuing to search for the mentioned CLASS I recall. -Bob Landman Tin Wiskers Problems, Causes, and Solutions DEPT. OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION *ORA/ORO/DEIO/IB*Date: 3/14/86 Number: 42 Related Program Areas: Medical Devices _______________________________________________________________ ITG SUBJECT: TIN WHISKERS - PROBLEMS, CAUSES, AND SOLUTIONS Recently, a little-known phenomenon called tin whiskering caused the recall of several models of a pacemaker. This incident revealed tin whiskers to be a general threat to all users and manufacturers of medical devices that incorporate electronic circuitry. To prevent future problems, field personnel will need to educate themselves and manufacturers. This guide is intended to help in this endeavor by describing the problems, causes, and solutions associated with tin whiskers. TIN WHISKERS later in the report: ment, and Criminal Investigations> Inspections> Inspection Guides Section Contents Menu Inspections Inspection Guides Inspection Technical Guides - Tin Wiskers Problems, Causes, and Solutions [Previous Chapter] [Table of Contents] [Next Chapter] DEPT. OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION *ORA/ORO/DEIO/IB*Date: 3/14/86 Number: 42 Related Program Areas: Medical Devices _______________________________________________________________ ITG SUBJECT: TIN WHISKERS - PROBLEMS, CAUSES, AND SOLUTIONS Recently, a little-known phenomenon called tin whiskering caused the recall of several models of a pacemaker. This incident revealed tin whiskers to be a general threat to all users and manufacturers of medical devices that incorporate electronic circuitry. To prevent future problems, field personnel will need to educate themselves and manufacturers. This guide is intended to help in this endeavor by describing the problems, causes, and solutions associated with tin whiskers. TIN WHISKERS Tin whiskers are metal filaments which grow from tin. They are extremely thin, 1-2uM typically, and grow as straight, kinked, or spiraled single crystals of tin. They can reach a length of 9mm (3/8") and carry 10mA of current before burning up. The electrical resistance of a tin whisker 3mm (1/8") long is about 50 ohms. Because of their current carrying ability and low electrical resistance, whiskers are a threat to electronic circuits. The ability of tin whiskers to cause electronic circuit problems was established in 1951. Many sudden failures and intermittent problems were associated with tin whiskers because of their ability to short closely spaced electronic circuits. Whiskers were found to grow across circuit connections and, because of their thin, brittle nature, would break free and lodge across circuits. Investigation into preventive measures was started, but solutions developed slowly due to the complex nature of tin whisker growth. The exact cause of tin whisker growth is still not fully understood. It is known that a whisker grows from its base and that the tin around the base does not thin as the whisker grows. It seems that the energy for growth comes from microstrains present in the tin or from externally applied pressure. Tin atoms appear to diffuse along screw dislocations within the tin and are pushed outwards by stresses. Growth rate varies tremendously, and it may be unsteady. Whiskers can fully develop in minutes or take decades to form. Spurts of growth may occur. The growth of tin whiskers is not directly related to the surrounding medium. Whiskers will grow in sealed components, under high vacuum, and in low or high humidity. Temperature has some effect on the rate of growth, and the thickness of tin deposits affects whisker density. An obvious factor affecting whisker growth is pressure. High-compression pressure from bolts or screws will always produce whiskers in tin deposits. It was 1974, two decades after the problem was recognized, that scientifically valid methods were established for controlling whisker growth. Two methods are currently used. The most common is to avoid using tin. Other metals or alloys of tin are used instead with solder (tin/lead) being the most popular. The other method is known as "reflow." After the tin is in place, the tin coated part is heated to a temperature above tin's melting point. This heating releases any stress that exists within the tin deposit. The FDA became interested in tin whiskers as the result of pacemaker failures. A group of pacemakers from a single manufacturer were found to have a high rate of failure due to tin whiskers growing from the tin-plated case of the pacemaker crystal component. An electrical bridge between the crystal and its case disabled the crystal component, resulting in the total loss of pacemaker output. The FDA issued a Class I recall for the affected devices and initiated a follow-up investigation. Examination of the manufacturing process revealed that the manufacturer's specification for the crystal component should have prevented tin-whisker growth. The crystal component specification called for gold, nickel, or solder plating. Any one of these case coatings would have prevented the tin whisker problem. The manufacturer, however, failed to test the crystal components for proper material composition. It relied on its vendor to deliver proper components. Unfortunately, a bad batch of crystal components resulted in 80 percent of the affected devices having tin-plated crystal components. From: ddhillma@xxxxxxxxxxxxxxxxxxx [mailto:ddhillma@xxxxxxxxxxxxxxxxxxx] Sent: Monday, January 25, 2010 1:15 PM To: Bob Landman Subject: Re: [LF] [tinwhiskers] FW: [SMART] Very useful RoHS review conference report Hi Bob - the link below did not work: ) FDA forced Medtronic to recall their implanted cardiac defibrilators (from patients bodies) when whiskers shorted the devices. http://www.fda.gov/ora/inspect_ref/itg/itg42.html Do you know what the valid link is? Dave