EN IEC 63000 is the standard listed in the Official Journal that triggers a presumption of conformity with the RoHS Directive 2011/65/EU. This means that if manufacturers evaluate their devices according to the standard, it is assumed that they meet the RoHS requirements.
EN IEC 63000:2018 has been valid since May 18, 2020 and replaced the almost identical EN 50581:2012, which has triggered the presumption of conformity since November 23, 2012. The draft standardization mandate for EN IEC 63000 was published on November 21, 2024. The revision is intended to specify the requirements and adapt them to the current state of the art.
What is EN IEC 63000?
- EN IEC 63000 is the harmonized standard for the RoHS Directive 2011/65/EU
- Title: Technical documentation for the assessment of electrical and electronic equipment with regard to the restriction of hazardous substances
- Content: Risk assessment of suppliers and materials: Is the supplier trustworthy and is it likely that a RoHS-restricted substance is contained in the product under consideration
What is a standardization request and what is the general procedure?
- Standardization mandates are regulated in Regulation (EU) No. 1025/2012 on European standardization.
- The European Commission can commission one or more European standardization organizations (CEN, CENELEC, ETSI) to develop a European standard within a specified period. [See (EU) 1025/2012 Art. 10.]
- First, a draft standardization request is published, thus initiating a consultation phase.
- After the consultation phase, the Commission publishes the final standardization request.
- The Commission finalizes the requirements for the content of the mandated document and the deadline for its adoption.
- The European standardization organization concerned shall declare within one month of receiving the request whether it accepts it.
- The Commission's decision on a request for funding from the standardization organization is announced, where appropriate, within two months of acceptance of the request.
- The European standardization organization responsible draws up a work plan and prepares the standard in accordance with the Commission's requirements.
What should change?
- The revised EN IEC 63000 should be more in line with Decision No. 768/2008/EC. This regulated the "New Legislative Framework" (NLF). The NLF decision serves to create a common legal framework with the help of common definitions of terms and procedures that make it possible to harmonize sectoral legislation and implement it more easily. Responsibilities are to be clearly allocated and the conformity assessment procedures are to be made available to legislators for selection by means of standardized modules. The legislators select the appropriate module depending on the potential risk of the product. The modules are, for example, Module A: Internal production control, Module B: EU type examination, etc. The draft does not change the module; it continues to provide for internal production control (Module A).
- More specific requirements (and therefore also assistance) are to be formulated for economic operators.
- A naming of exceptions including justification and concentration of the relevant substance is required.
- More verifiable technical documentation, through mandatory test reports "where appropriate".
What is the current status?
- The draft standardization mandate has been published, but has not yet been adopted by the Commission.
- Open: A final standardization request will be published by the Commission, which will then be adopted by the standardization organization within one month.
- Open: CENELEC is envisaged as the European standardization organization that will then draw up a work plan.
- Open: The draft standardization mandate provides for CENELEC to submit an initial report to the Commission within 15 months of adoption and a final report within 32 months of adoption. The deadlines can be extended by CENELEC if necessary.
After acceptance of the standardization request by CENELEC, the organization has just a little over 2.5 years to develop a new standard.
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Author's note
This article has been machine translated into English.
TERMS AND ABBREVIATIONS
CEN: European Committee for Standardization
CENELEC: European Committee for Electrotechnical Standardization
ETSI: European Telecommunications Standards Institute
NLF: New Legislative Framework
