Circuits Assembly - November 2008 - (Page 26)

Cover Story SERIES RoHS Conversion for Medical Devices By Kim Sharpe Risks, considerations and impacts, plus several BoM analysis case studies. T he European Union’s Restriction of Hazardous Substances Directive was adopted in Febuary 2003 and took effect in July 2006. Exemption categories defined in the Waste Electrical and Electronic Equipment (WEEE) Directive under Annex IA and IB that also apply to the RoHS Directive include medical devices (Category 8) and monitoring and control instruments (Category 9). The EU recognized these products are typically manufactured in small numbers and have a long product life. Products within these categories are often used in critical applications where a failure may have a significant impact. Long-term effects of Pb-free solder and the associated new materials used in these products are not fully known. In the ERA Technology Final Report, researchers stated it is not yet possible, on the basis of accelerated test data, to predict accurately the field life of equipment used for more than 10 years in a hostile environment. This is because comparable field data for products made Table 1. Medical Compliance Dates Sector Other medical devices IVD AIMD Category 9 exempt Date for Inclusion in Scope 2012 2016 2020 (or never) 2012 with Pb-free solder are not yet available. Based on the concern for potential manufacturing defects, thermal fatigue, tin whiskers, vibration failures and corrosion, the EU established a temporary moratorium for Category 8 and 9 products. Working with the European Commission, ERA Technology recommended these products remain exempt from the RoHS Directive until 2012 or 2020, depending on specific product categories and applications (Table 1).1 This six-to-14-year window provides medical OEMs time to redesign products, undertake more reliability testing and obtain appropriate approvals.2 A number of additional countries are considering or deploying environmental regulations similar to RoHS and WEEE. With medical products exempt from the EU directives, medical companies are contemplating waiting versus compliance. Multiple factors should be taken into consideration. • Environmental laws – Medical products are still exempt from RoHS compliance; however, the official China Catalogue is not yet released, so medical product status there is unknown. Other countries developing or enacting environmental laws include Japan, South Korea and Australia. The process of medical product design, validation, clinicals and release is long; OEMs should keep this in mind. • Marketing – Consumers are becoming more aware of the environmental impact and “greening” of electronics. Some use “green” as a factor in product selection. Some companies reportedly have obtained a five to 10% market share increase by selling green products. circuitsassembly.com 26 Circuits Assembly NOVEMBER 2008 http://www.circuitsassembly.com

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Circuits Assembly - November 2008 Contents Caveat Lector Industry News Market Watch Talking Heads Focus on Business On the Forefront Screen Printing Better Manufacturing RoHS Conversion for Medical Devices Supporting Full-Service Customer Requirements at the Regional EMS Level Speed Thrills Tech Tips Wave Soldering Process Doctor Pb-Free Lessons Learned The Defects Database Getting Lean Materials World Product Spotlight Ad Index Assembly Insider Technical Abstracts

Circuits Assembly - November 2008

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