In May 2012, the European Commission included EN 16128:2011 as a harmonised standard for Entry 27 Nickel release in Annex XVII under REACH. The standard is almost the same as EN 1811:1998+A1:2008 technically. CEN passed the EU amendment for nickel release (EN 1811-2011+A1:2015) and amended EN 16128:2015 correspondingly in June.
Here is a comparison list between the new standard EN 16128:2015 and EN 16128:2011:
EN 16128:2015 | EN 16128:2011 | |
Title | Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release | Reference test method for release of nickel from those parts of spectacle frames and sunglasses intended to come into close and prolonged contact with the skin |
Test Method | For parts with organic coating: the test is based on Electrochemical Impedance Spectroscopy (EIS) For parts without organic coating: a migration test using artificial sweat solution into a test paper (incubation at defined conditions for 1 week) and subsequent quantitative analytical detection of nickel released into the test paper | Parts to be tested are placed in an artificial sweat solution for 1 week follow by analytical detection |
Result Assessment | EIS Test Impedance ≥ 3.0 x 105 Ω.cm² is deemed compliant Migration Test < 0.76 μg/cm²/week is deemed compliant | Test result x 0.1 (adjusted value) follow by comparison with regulatory requirements |
Requirement | Entry 27 Nickel release in Annex XVII under REACH≤ 0,5 μg/cm²/week | |
Implementation | It becomes a national standard by May 2016; All conflicting standards will be repelled by November 2018. | It became a harmonised standard in May 2015. |
【中文版】
Further information
Download EN 16128:2015