RoHS Compliance

RoHS Compliance

BTE is an international distributor of medical equipment and is required to stay compliant with international regulations.   From July 2014, BTE is conformant to the RoHS Directive which dictates that the raw materials used in our products may not contain certain substances (listed below).  RoHS stands for Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment and is being implemented worldwide.

For BTE to meet this directive, BTE works with our suppliers to verify they supply BTE with materials that conform to the specification. Please review the information below to verify that the materials your company supplies to BTE conform to the RoHS directive (RoHS 2011/65/EU +(EU)2015/863, Annex II).

According to the RoHS Directive, the six restricted substances and maximum concentration values tolerated by weight in homogeneous materials (this includes the raw materials and any processes performed to the raw materials during manufacture):

Material Max Limit
(wt%)
Lead [Pb] 0.1 %
As an alloying element in steel for machining purposes 0.35 %
In galvanized steel 0.35 %
In Copper Alloys 4 %
In Aluminum Alloys 0.4 %
Cadmium [Cd] 0.01 %
Mercury [Hg] 0.1 %
Hexavalent chromium [Cr+6] 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 %
Dibutyl phthalate [DBP] 0.1 %
Diisobutyl phthalate [DIBP] 0.1 %

 

A homogeneous material is either:

  • A material with a uniform composition throughout; or
  • A material that consists of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding or abrasive processes.
    • Examples of homogeneous materials include a plastic cover to a computer screen, a copper wire inside a cable, wiring insulation and the solder part of a solder joint.
    • All equipment consist of many different homogeneous materials and the maximum concentration values are applied to each of the homogeneous materials individually.

Suppliers cannot perform any substitutions for the materials on BTE drawings without pre-approval.

If you have any questions or concerns, please contact BTE.