Proterial Cable America’s High-Performance Medical Solutions (PCA-HPMS) manufactures our components with safety, reliability, and sustainability in mind.
Meeting our expectations for quality and safety requires strict adherence to global regulatory standards like REACH, RoHS, and UL. Each of these standards guides our product development and gives us a north star to follow for both safety and environmental requirements.
REACH, or Registration, Evaluation, Authorization, and Restriction of Chemicals, is a European Union regulation that aims to protect human health and the environment from risks associated with chemical substances. PCA-HPMS follows REACH standards by documenting our chemical usage. That way our team and REACH work together to present products that are safe for our customers as well as valuable ecosystems.
As of November 2024, the Candidate List of Substances of Very High Concern (SVHC) contains 242 entries. At PCA-HPMS, we need to closely monitor materials used in medical devices to make sure we remain compliant. When new substances are added to the list, it can mean material reformulations. We’re proactive in our efforts to meet these ever-evolving standards.
Harmful substances like lead or mercury can be found in electronic equipment. The Restriction of Hazardous Substances (RoHS) directive limits the use of substances like these to make sure the public is kept safe.
Initially, the directive only covered a small list of substances but the list has grown over the years especially due to environmental concerns.
PCA-HPMS understands the importance of RoHS compliance. By adhering to these standards, we:
REACH and RoHS both look to keep people and the environment safe, but they are not the same thing. In fact, there are some key differences:
By following both guidelines, HPMS products are comprehensively compliant with regulatory expectations.
Accepted throughout the world as a premier safety standards organization Underwriters Laboratories (UL) ensures a product meets strict safety and performance criteria. Although not always a primary evaluator for medical devices, PCA-HPMS follows UL standards whenever necessary. 
UL introduces updates regularly addressing everything from electrical equipment used in labs to cleanroom standards. PCA-HPMS integrates these standards into our manufacturing processes to make sure our products are safe and high-quality.
The Proactive Approach of PCA-HPMS:
The commitment the team at PCA-HPMS shows to REACH, RoHS and UL standards highlights who we are. Our customers’ safety, our products’ reliability and our understanding of our responsibility to the environment are our expectations. Our dedication to each of these goals and industry leadership demonstrate why we are the right company to work with.
For more information about PCA-HPMS and our compliance initiatives, visit our website. For questions about our products, please contact us today!
