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About EU nickel release new standard method EN 1811-2011+A1:2015

時間:2016-01-21 10:51 點擊:
20 July 2015, EU published the nickel release standard method EN 1811-2011+A1:2015, amending EN 1811-2011+A1:2015 which are mainly for presumption of conformity with nickel release in entry 27 under ANNEX XVII of REACH. The new standard will be more beneficial to help with the judgement
REACH nickel release requirements:
According to entry 27 of REACH Annex XVII, nickel shall not be used:
(a)  in any post assemblies which are inserted into pierced ears and other pierced parts of the human body unless the rate of nickel release from such post assemblies is less than 0,2 μg/cm2/week (migration limit);
(b)  in articles intended to come into direct and prolonged contact with the skin if the rate of nickel release from the parts of these articles coming into direct and prolonged contact with the skin is greater than 0,5 μg/cm2/week.
For the uncertainty of the test method, EN 1811:2011 introduced a ‘measurement of uncertainty’, dividing the test results into 3 categories: Compliant, Inconclusive, Non-compliant. The new document EN 1811:2011+A1:2015 deletes the inconclusive category and define that, if the test result of body piercing components are less than 0.35µg/cm2/week, and articles intended to come into direct and prolonged contact with the skin less than <0.88µg/cm2/week, then they are conform with the REACH ANNEX XVII requirements.
Comparison with the existing standard method are listed below:
  Post assemblies and body piercings Other components in direct and prolonged contact with the skin
REACH Annex XVII requirements (µg/cm2/week) 0.2 0.5
Nickel release (µg/cm2/week) <0.11 0.11-0.35 ≥0.35 <0.28 0.28-0.88 ≥0.88
EN 1811:2011 Compliant Inconclusive Non-compliant Compliant Inconclusive Non-compliant
EN 1811-2011+A1:2015 Compliant Non-compliant Compliant Non-compliant
HCT has the test capability of nickel release, could help provide nickel release test to enterprises.
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