Manufacturers whose medical products are imported to the European Union (EU) will need to comply with the environmental directive, Restriction of Hazardous Substances (RoHS), as of July 22, 2014. Often called the “lead-free” directive, RoHS covers electronic assemblies and equipment and restricts six dangerous substances: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyls. While medical products have long been exempt from this regulation, the RoHS directive was recently updated, changing the definition of electrical and electronic equipment, expanding the categories of products that need to comply and altering how the conformity must be declared. The EU will require RoHS compliance for all medical devices that are not implantable or critical to an implantable device’s operation. An incomplete list of products includes: anesthesia equipment, analyzers (blood, cholesterol and sugar), blood pressure meters, defibrillators, dental equipment……..See Testimonial PDF
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