RoHS CONVERSION FOR MEDICAL DEVICES: RISKS, CONSIDERATIONS AND COMPANY IMPACT PLUS SEVERAL BOM ANALYSIS CASE STUDIES

摘要

Medical products are exempt under the EU RoHS Directive; however, product marketing and component supply chain concerns are pushing many medical companies to assess whether or not to convert their products to RoHS compliance (Lead-Free). As an example, some components are only being offered in a Pb-free configuration, which makes SnPb assembly more difficult to sustain. Companies face risks associated with either converting or not converting to RoHS compliance. This paper will discuss some of those risks and what considerations should be taken into account. Some areas covered will be tin whisker mitigation, analysis and criteria/rating methods; design changes and verification; material availability and cost; and component obsolescent and sourcing. When a company converts products to RoHS compliance, there is an impact on their internal procedures and processes. Some key areas to address include product documentation, supplier requirements, Broker parts, and due diligence methodology.