Making Sense of the RoHS2 Directive for Medical Devices

Learn more today about non-electrical items and if they are included in the RoHS2 directive.

10 February 2014

Have you ever wondered if non-electrical items such as blood pressure cuffs are included in the RoHS2 directive? Today, these types of questions are common. But why? It comes down to what constitutes an electrical product.

If the blood pressure cuff is used as part of an electrical product, then it is considered part of an electrical product's system and is (in fact) included in the scope of the directive – even if it is sold individually. More specifically, it's important to note that a comprehensive supply chain verification must address all aspects of the product and its packaging, not just the electronic components.

Examples of non-electronic peripheral items that may be considered to be part of the medical electronic device include:

  • enclosures
  • connectors
  • interconnects
  • accessories

With the rapidly approaching compliance deadline of July 22, 2014, what other areas of the directive need clarification? Please leave your question or comment below and one of our experts will get back to you.

Today's expert is Joe Langton, Business Service Line Leader within Intertek's Chemical unit. For the past five years, he has provided comprehensive compliance solutions related to the RoHS Directive, Restricted Substances, CPSIA, REACH, End of Life Management and Electronics Recycling, Environmentally Preferable Materials, and California Proposition 65. Joe is based out of the Allentown, Pennsylvania office.