The RoHS (Restriction of Hazardous Substances) Directive, which restricts the use of environmentally harmful substances in electrical and electronic products, has become one of the most important regulations that manufacturers and suppliers must comply with. The EN IEC 63000:2018 standard specifies the process for manufacturers to prepare technical documentation and defines the methods to be applied to assess whether products contain hazardous substances.
EN IEC 63000:2018 provides guidance on how manufacturers should establish their technical files to ensure compliance with Directives 2011/65/EU (RoHS 2) and 2015/863/EU (RoHS 3). This standard updates the previous EN 50581:2012 standard and clarifies the procedures required for RoHS compliance. Manufacturers must use specific methods to prove that hazardous substances such as lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (Cr6+), PBB and PBDE in their products are within limit values.
The standard specifies the steps manufacturers should follow in the technical documentation process:
- Product definition and identification of components – All materials and sub-assemblies should be examined to assess the presence of harmful substances.
- Collection of supplier declarations and material reports – Manufacturers should request documentation from their suppliers demonstrating RoHS compliance.
- Use of analytical test methods – Laboratory tests should be performed on particularly risky components using standard test methods such as IEC 62321.
- Update and validate technical documentation – Manufacturers should regularly review documentation to ensure compliance with current regulations.
EN IEC 63000:2018 allows manufacturers to create a technical dossier based not only on test results, but also supplier declarations, material analysis and past compliance records. This process not only ensures compliance with RoHS requirements, but is also a requirement for entry into the EU market. EN IEC 63000:2018, which is part of the RoHS compliance process, clearly sets out the path that companies should follow to document their compliance with legal regulations. Especially for companies operating in global markets, fulfilling the requirements of this standard is critical for both gaining competitive advantage and supporting sustainable production processes.
