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New Harmonized Standard EN IEC 63000:2018 Announced by EU Commission

SafeGuardSEE Restricted Substances, Electrical Medical Devices, EcodesignJune 10, 2020

New harmonized standard EN IEC 63000:2018 – Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances (IEC 63000:2016), replaces standard EN 50581:2012 for assessing the technical documentation in support of compliance assessment of Directive 2011/65/EU (RoHS 2).

According to the Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS), manufacturers need to provide technical documentation and carry out an internal production control procedure in line with Module A of Annex II of Decision 768/2008/EC to demonstrate RoHS compliance. The EU commission initiated a process to develop a harmonized standard to guide manufacturers on their way to correct technical documentation. The first harmonized standard EN 50581:2012 was made available on September 21, 2012 by the European Committee for Electrotechnical Standardization (Cenelec). Recently, Cenelec has revised the existing harmonized standard EN 50581:2012, leading to the adoption of standard EN IEC 63000:2018, which sets out specifications for the technical documentation required for assessing materials, components and electrical and electronic equipment with respect to the restriction of the use of certain hazardous substances. The new standard EN IEC 63000:2018 is based on the existing international standard IEC 63000:2016, which itself is based on the harmonized standard EN 50581:2012.

In setting the necessary technical documentation requirements, EN IEC 63000 is almost identical to the EN 50581. However, the wording specific to the EU RoHS Directive has been removed: it aims at addressing different substance regulations worldwide while ensuring the same approach from manufacturers everywhere. The normative references of EN 50581:2012 were updated in EN IEC 63000 in order to reflect the latest international development of analytical test methods and material declaration. The implementation of the standard ensures the assessment of electrical and electronic equipment, with respect to the restriction of hazardous substances, and therefore increases trust in electronic and electrical equipment (EEE) manufacturers.

Since the later standard EN IEC 63000:2018 replaces EN 50581:2012 as the harmonized standard, it is necessary to withdraw the reference of standard EN 50581:2012 from the Official Journal of the European Union. In order to give manufacturers sufficient time to adapt their products to the new standard, the commission implementing decision (EU) 2020/659 of 15 May 2020 stipulates that the harmonized standard EN 50581:2012 will be withdrawn from November 18, 2021.

Considering that the withdrawal date of existing harmonized standard EN 50581:2012 is coming soon, and a large number of products on the market are referring to it in their Declaration of Conformity, manufacturers need to update their processes referencing EN IEC 63000:2018 to demonstrate RoHS 2 compliance.

As the world’s leader in third party testing, SGS has the global knowledge and local expertise to help you achieve compliance with electrical and electronic regulations covering product safety, electromagnetic compatibility (EMC), hazardous substances (RoHS, REACH, SVHC etc), energy efficiency, ecodesign, ErP, performance and reliability, as well as with many other consumer product related requirements. Whether you are in need of testing or services in the fields of inspection, certification, compliance assurance, outsourcing, training or auditing, SGS is ideally positioned to satisfy your needs.

For enquiries, please contact:

Martin Du
Technical Supervisor, EET RSTS
t: (86) 755 2532 8761 

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