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Attention Medical Device Manufacturers: RoHS Affects You

The good news is RoHS compliance is much easier now

Grant Ramaley
Mon, 04/14/2014 - 16:59
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Electrically powered medical equipment will soon be subject to the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU.

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As of July 22, 2014, most powered equipment sold within the European Union (EU) must not contain more than the allowed quantities for each homogeneous material listed below:
• Lead (0.1 %)
• Mercury (0.1 %)
• Cadmium (0.01 %)
• Hexavalent chromium (0.1 %)
• Polybrominated biphenyls (PBB) (0.1 %)
• Polybrominated diphenyl ethers (PBDE) (0.1 %)

Homogeneous material means one material of uniform composition throughout or a material consisting of a combination of materials that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding, and abrasive processes. This is somewhat frightening, as even small electronic parts could be “ground” into a variety of homogenous materials.

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