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Amended RoHS Directive to Include Phthalates Comes into Effect for Medical Device Manufacturers



As of July 22nd 2021, medical device manufacturers must be able to demonstrate compliance to the delegated RoHS Directive 2015/863/EU to include the four RoHS phthalates BBP, DEHP, DBP, and DIBP. The delegated RoHS Directive in an amendment to RoHS 2 (Directive 2011/65/EU), which originally restricted six substances used in the manufacture of many types of electronic and electrical equipment (EEE).

Together, the ten substances listed below have been found to be hazardous to the environment and dangerous in terms of occupational exposure that can occur during the manufacture and disposal of EEE.

RoHS 2 (2011/65/EU)

Lead (Pb)

Mercury (Hg)

Cadmium (Cd)

Hexavalent Chromium (Cr6+)

Polybrominated biphenyl (PBB)

Polybrominated diphenyl ether (PBDE)

RoHS 2 (2015/863/EU)

Benzyl butyl phthalate (BBP)

Bis (2-ethylhexyl)phthalate (DEHP)

Dibutyl phthalate (DBP)

Diisobutyl phthalate (DIBP)

The four phthalates added to the RoHS Directive are most often used as plasticizers, which are substances that are added to materials to increase flexibility and reduce brittleness. These RoHS-regulated plasticizers are commonly found in PVC, adhesives, inks, and acrylics and are also found on the REACH SVHC Candidate List due to their endocrine-disrupting properties.

Some examples of medical devices which are now required to be RoHS compliant (to include the four phthalates are:

Blood pressure meters

Defibrillators

Dental equipment

Dialysis equipment

Hearing aids

Intravenous drug infusion pumps

Medical lasers

Oxygen analyzers

Surgical microscopes

Ventilators

X-ray devices

Total Parts Plus has pre-emptively worked to obtain RoHS compliance to include BBP, DEHP, DBP, and DIBP for all our medical customers, and continues to have an extensive and ever-expanding compliance database covering EU RoHS, EU REACH, Conflict Minerals, Prop 65, POPs, material declarations, and more. Reach out to our team of industry and regulatory experts today to request a demonstration of our suite of compliance software tools.