Medical Device Compliance 60601-1-2 Editor's Note: Elliott Laboratories CTO David Bare published the following article in the March 2005 edition of Conformity Magazine. Medical Device Compliance IEC 60601-1-2 - Essential Performance, Risk Analysis And Immunity By David Bare, CTO, Elliott Laboratories When the second edition of Basic Standard: IEC/EN 60601-1-2 became the mandatory EMC standard for medical devices on November 1, 2004, the EMC landscape for medical electrical equipment was changed forever. Although EMC immunity test requirements for medical products are very similar to those applied to other product types, such as radio equipment, networking equipment, and information technology equipment, Basic Standard: IEC 60601-1-2 requires that the performance criteria address all "essential functions" of the medical device. Essential functions may be determined from a risk analysis. The outcome of this analysis should identify the performance associated with each function of the device that is "necessary to maintain the residual risk within acceptable limits". (Basic standard: IEC 60601-1-2 Edition 2, section 2.210. It may not be possible to assess multiple functions simultaneously; therefore each test may need to be repeated. Without the risk analysis, all functions are considered to be essential so a risk analysis is necessary to minimize the amount of testing. Having determined the functions, and their associated parameters, that need to be evaluated during immunity tests, the next step is to develop a test plan that addresses how each function will be evaluated, identify those functions that can be evaluated simultaneously and provide the cycle time for each of these functions... Read full article Microsoft Enacts Voluntary Xbox Recall Demonstrating good corporate responsibility and a healthy respect for the business risks of placing hazardous products on the market, Microsoft enacted a voluntary recall of 14 million Xbox power cords in February. The company says that the cords are a potential safety hazard, with at least 30 reports of burned hands and/or damaged property. The recall affects about 70 percent of the approximately 20 million game consoles sold. Microsoft states that failure rates have been very low, affecting less than 1 in every 10,000 Xboxes sold. Nevertheless, the company took a cautious position and decided to voluntarily recall the units before any additional problems could arise. The recall affects Xboxes manufactured before Oct. 23, 2003. Fortunately for Microsoft, the replacement cords can be easily installed by customers. Had the cords been fixed to the console clearly the costs of the recall would have been signficantly higher. As the power cords bear the marks of numerous safety certification authorities, the problem clearly seems to be a manufacturing error and not a design error. For more information on the Microsoft Xbox recall, please visit: Microsoft Xbox Recall Compliance Bulletin Enforcement Free EMC Directory FREE. Interference Technology's 2005 EMC Directory & Design Guide. This 272-page practical guide to EMC will be available shortly. Sign up for a copy now. For the first time, the 2005 edition will be available in both printed and digital (eGuide) formats. Subscription is FREE. To request your free copy of the Interference Technology's 2005 EMC Directory & Design Guide, please click here Existing subscribers: You must update your subscription for access to our new eGuide. SUBSCRIBE NOW! 684 W. Maude Avenue Sunnyvale, California 94085 www.elliottlabs.com