Regulatory News

CEN Published EN 12472:2020 Method for Simulation of Accelerated Wear and Corrosion for Detection of Nickel Release from Coated Items

Nov. 2 2020

CEN has published the 2020 version of EN 12472 “Method for the simulation of accelerated wear and corrosion for the detection of nickel release from coated items.” This method is to be used prior to the detection of nickel release from coated articles that come into direct and prolonged contact with the skin. 

Major Changes: 
•    Clarification of articles covered by the scope of the standard – does not apply to articles with an outer coating containing nickel and those which are inserted into pierced ears and other parts of the human body
•    Clarification of concentration of the lactic acid stock solution – purity of DL-lactic acid shall be  > 88% for the preparation of corrosive medium 
•    Requirements for granules have been changed – out shells of coconuts, ground and sieved to give a mixture of particles having dimensions between 0.8 mm and 1.3 mm 
•    Update of normative references – 
    o    EN 1811 “Reference test method for release from nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin”
    o    EN 16128 “Ophthalmic optics – Reference method for the testing of spectacle frames and sunglasses for nickel release”
•    Include statement that testing can be performed according to CR 12471 if only indicative information on the extend of nickel release or the presence of nickel is required 

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2021, and conflicting national standards shall to be withdrawn at the latest by March 2021. 

This standard is expected to be harmonized under Regulation (EC) 1907/2006 when it is accepted by the European Commission and announced in the Official Journal of the European Union (OJEU).  

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