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Impact Analytical offers RoHS Testing Services for restricted substances in many product streams, including medical devices.

RoHS stands for Restriction of Hazardous Substances and impacts the entire electronics industry and many electrical products as well. The original RoHS, also known as Directive 2002/95/EC, originated in the European Union in 2002 and restricted the use of six hazardous materials found in electrical and electronic products. All applicable products in the EU market since July 1, 2006 must pass RoHS compliance.

The EU RoHS Directive (2011/65/EU) restricts the maximum allowable levels of lead (Pb), cadmium (Cd), mercury (Hg), hexavalent chromium (Cr6+), polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants to 0.1% or 1000 ppm (except cadmium, which is limited to 0.01% or 100 ppm) by weight of homogeneous material in electrical equipment and electronic products. In order to manufacture these products within or import into the European Union, manufacturers are responsible for providing due diligence documentation.

Directive 2011/65/EU was published in 2011 by the EU, and is known as RoHS-Recast or RoHS 2. RoHS 2 includes the CE-marking directive, with the RoHS compliance now being required for CE marking of products. RoHS 2 added additional categories and compliance record keeping requirements.

RoHS 3 (EU Directive 2015/863) adds Category 11 (catchall) products and adds four new restricted substances - all phthalates. The four phthalates are mainly used as insulation plasticizers, and are on the REACH list of SVHC (Substances of Very High Concern). The expanded list for RoHS 3 is as follows:

• Cadmium (0.01%)

• Lead (0.1%)

• Mercury (0.1%)

• Hexavalent chromium (0.1%)

• Polybrominated biphenyls (PBB) (0.1%)

• Polybrominated diphenyl ethers (PBDE) (0.1%)

• Bis (2-ethylhexyl) phthalate (DEHP) (0.1%)

• Butyl benzyl phthalate (BBP) (0.1%)

• Disbutyl phthalate (DBP) (0.1%)

• Diisobutyl phthalate (DIBP) (0.1%)

During testing, each different component part is analyzed separately. The current restrictions apply to each different material, not the entire product.

“The restriction of DEHP, BBP, DBP, and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control, instruments, including industrial monitoring and control instruments, from 22 July 2021.”

Since the adoption of EU RoHS, a number of other jurisdictions have created, or are in the process of creating, similar Restriction of Hazardous Substances (RoHS) legislation including China RoHS, Korea RoHS, California RoHS, Taiwan RoHS, Turkey RoHS, India RoHS, and the United Arab Emirates (UAE) RoHS.

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