EN 1811 is updated for Methods to Analyse Allergens Related to Nickel

Clause(s)

Changes

General

Unit for nickel release “µg·cm-2·week-1” is used, which is equivalent to the unit “µg/cm2/week” used in the REACH

5.5, 5.6

Added permission for ready-to-use solutions (sodium hydroxide & hydrochloric acid solutions)

5.9

Added notes for the application of wax or lacquer for masking. Samples are dipped into molten wax when using wax; 2 to 3 coats of lacquer might be required when using lacquer

8.2

A note is added for rinsing sample with test solution

8.2

Permission is given for the clarification of filtering release solution, which could be done with syringe filter to avoid damage to the analytical spectrometer or the blocking of instrument’s capillary

9.2.2.1

It is now clarified that the nickel release result of each sample has to be compliant with the migration limit when more than one sample of the same article is tested

9.2.2.2

Update the result interpretation for articles with a migration limit of 0.5 µg·cm-2·week-1: the result is compliant when it is ≤ 0.88 µg·cm-2·week-1, instead of <0.88 µg·cm-2·week-1 as in the previous version

10

In the new test report requirements, sample area used for calculation and volume test solution could be reported per request

General

Deleted the requirements for quality control material (reference discs)

Annex B.3

Clarified that both test methods should be applied (EN 1811 with and without EN 12472) when uncertainty exists about the presence of nickel in the outer coating

Annex B

Summarized the preparation of samples in table form with added examples. Each individual sub-part shall comply with the requirement of nickel released when it is in direct and prolonged contact with skin. Homogenous sub-part could be obtained by disassembling, cutting or masking

Annex B.4.2.6

There is now a flowchart for sample preparation and test procedure for complete watches