Millions of patients worldwide depend on the ever-expanding world of medical devices, ranging from those that monitor blood pressure to those that diagnosis disease. These patients depend on medical equipment to be safe for use inside and outside of the body. Accordingly, the Federal Drug Administration, European Union, and other regulatory bodies around the world require medical devices to meet certain requirements before being sold within their countries.
PlasticsOne products are designed to conform to the demands and requirements of safety, health, and environmental regulations worldwide. We are dedicated to serving our customers by providing high quality products that meet these environmental regulations, including REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances). Our company works daily to stay abreast of new and changing regulations because we understand how important compliance is to our customers.
'RoHS Compliant' means that the substances restricted by the EU Directive 200295/EC and the subsequent amendments of the European Parliament are not contained in a finished product above threshold limits stated below.
Starting in 2007, the European Union Regulation (EC) 1907/2006 concerning the REACH, began regulating the substances that are manufactured or imported within the EU. Plastics One is constantly monitoring the substances of very high concern (SVHCs), as defined by REACH, in our products. This is an ongoing process since the complete list of SVHC’s are released every six months. Additional information can be found on the European Chemicals Agency’s website.
PlasticsOne complies with RoHS and REACH, as well as, other Environmental Regulations. We welcome the opportunity to discuss your company’s specific requirements.