Question: My company is in the process of certifying a product as compliant with the EU Restriction of Hazardous Substances (RoHS) Directive. We are performing due diligence and collecting compliance information. Part of the process refers to preparing a "technical file." What should go in this technical file, and how can I find out more about it?
Answer: Preparing a technical file is a necessary step to ensure EU RoHS compliance for your product (along with preparing a Declaration of Compliance and affixing the CE marking). A technical file is a collection of specific technical information about the product.
Article 7 of RoHS 2 (Directive 2011/65/EU) refers manufacturers to technical file standards in Module A within Annex II of Decision 768/2008/CE. This states that the following elements should be included in a product's technical documentation, wherever applicable:
- “A general description of the product.
- Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
- Descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product.
- A list of the harmonised standards and/or other relevant technical specifications that apply (either completely or in part) to the product, and descriptions of any solutions applied to meet legislative requirements in cases where harmonised standards to not apply.
- Results of design calculations made, examinations carried out, etc.
- Test reports from any appropriate testing that has been conducted.”
The global harmonized standard for assessing technical documentation with respect to EU RoHS compliance is IEC 63000:2018. This standard is available for purchase through various European countries' national standards organizations, and from other organizations such as the American National Standards Institute (ANSI, BS EN IEC 63000:2018).
This article is current as of 2021-07-09.