RoHS Directive- Steps to Compliance and Exemptions -- MEDICA - World Forum for Medicine


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RoHS Directive- Steps to Compliance and Exemptions

The Restriction of the use of certain Hazardous Substances specifies maximum levels for use of 6 restricted hazardous substances in the manufacture of various types of Electrical and Electronic Equipment (EEE).

RoHS Compliance

1. Introduce Product
2. Determine if your product contains more than the specified levels of restricted substances
3. Determine your compliance systems and data quality systems
4. Self Declaration
5. Identify EU Member states requirements for complying with RoHS
6. Comply with individual members state requirements, including certificate of testing and Bill of Materials

RoHS coincides with the WEEE Directive as part of a legislative initiative to solve the problems and risks associated with large amounts of electric waste.
The WEEE Directive lists 10 categories that define the different groups of Electronic Electric and Electronic Equipment (EEE). These categories are also the groups specified for the RoHS Directive.
However, there are 3 categories in the WEEE section that are exempt from RoHS, specifically Category 8, which covers Medical Devices. These products remain exempt from the RoHS directive until 2012 or 2018, depending upon specific product sub-categories and applications. Since the EU has not yet adopted this recommendation, the exact timing of RoHS application to these products remains uncertain.

Category 1: Large and small household appliances
Category 2: IT equipment
Category 3:Telecommunications equipment (infrastructure equipment is exempt from RoHS in some countries)
Category 4: Consumer equipment
Category 5: Lighting equipment (including electric light bulbs and luminaries in households)
Category 6: Electronic and electrical tools
Category 7: Toys, leisure and sports equipment
Category 8: Medical Devices (EXEMPT FROM ROHS)
Category 9: Monitoring and control instruments (exempt from RoHS)
Category 10: Automatic dispensers

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