Screening test for the presence of nickel in articles which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin

This document provides a screening test based upon the use of dimethylglyoxime for detecting the presence of nickel in articles that are inserted into pierced parts of the human body and those that are intended to come into direct and prolonged contact with the skin.
This screening test is suitable for manufacturers and importers as a qualitative method for detecting the presence of nickel in articles.
NOTE   The reference method for the measurement of nickel release is EN 1811, or for spectacle frames and sunglasses, EN 16128.

Screeningverfahren für die Nickelabgabe aus Erzeugnissen, die in durchstochene Körperteile eingeführt werden, und Erzeugnissen, die unmittelbar und länger mit der Haut in Berührung kommen

Méthode de détection qualitative du nickel dans les articles introduits dans les parties percées du corps humain et les produits destinés à entrer en contact direct et prolongé avec la peau

Le présent document spécifie une méthode de détection qualitative basée sur l’utilisation de la diméthylglyoxime pour détecter la présence de nickel dans les articles qui sont introduits dans les parties percées du corps humain et de ceux destinés à entrer en contact direct et prolongé avec la peau.
Cette méthode de détection qualitative convient aux fabricants et importateurs en tant que méthode qualitative pour détecter la présence de nickel dans les articles.
NOTE   La méthode de référence pour mesurer la libération de nickel est celle de l’EN 1811, ou celle de l’EN 16128 pour les montures de lunettes et les lunettes de soleil.

Presejalna metoda za prisotnost niklja v izdelkih, vstavljenih v prebodene dele človeškega telesa, in izdelkih, namenjenih neposrednemu in daljšemu stiku s kožo

General Information

Status
Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
23-Feb-2022
Completion Date
23-Feb-2022

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SLOVENSKI STANDARD
kSIST-TP FprCEN/TR 12471:2021
01-november-2021
Presejalna metoda za prisotnost niklja v izdelkih, vstavljenih v prebodene dele
človeškega telesa, in izdelkih, namenjenih neposrednemu in daljšemu stiku s kožo

Screening test for the presence of nickel in articles which are inserted into pierced parts

of the human body and articles intended to come into direct and prolonged contact with

the skin
Screeningverfahren für die Nickelabgabe aus Erzeugnissen, die in durchstochene

Körperteile eingeführt werden, und Erzeugnissen, die unmittelbar und länger mit der

Haut in Berührung kommen

Méthode de tri pour la libération du nickel sur les articles qui sont introduites dans les

parties percées du corps humain et les produits destinée à entrer en contact direct et

prolongé avec la peau
Ta slovenski standard je istoveten z: FprCEN/TR 12471
ICS:
39.060 Nakit Jewellery
kSIST-TP FprCEN/TR 12471:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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kSIST-TP FprCEN/TR 12471:2021
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kSIST-TP FprCEN/TR 12471:2021
FINAL DRAFT
TECHNICAL REPORT
FprCEN/TR 12471
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
September 2021
ICS 39.060 Will supersede CR 12471:2002
English Version
Screening test for the presence of nickel in articles which
are inserted into pierced parts of the human body and
articles intended to come into direct and prolonged
contact with the skin

Méthode de tri pour la libération du nickel sur les Screeningverfahren für die Nickelabgabe aus

articles qui sont introduites dans les parties percées du Erzeugnissen, die in durchstochene Körperteile

corps humain et les produits destinée à entrer en eingeführt werden, und Erzeugnissen, die unmittelbar

contact direct et prolongé avec la peau und länger mit der Haut in Berührung kommen

This draft Technical Report is submitted to CEN members for Vote. It has been drawn up by the Technical Committee CEN/TC

347.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are

aware and to provide supporting documentation.

Warning : This document is not a Technical Report. It is distributed for review and comments. It is subject to change without

notice and shall not be referred to as a Technical Report.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TR 12471:2021 E

worldwide for CEN national Members.
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kSIST-TP FprCEN/TR 12471:2021
Contents Page

European foreword ...................................................................................................................................................... 3

Introduction .................................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Normative references .................................................................................................................................... 5

3 Terms and definitions ................................................................................................................................... 5

4 Principle ............................................................................................................................................................. 5

5 Reagents ............................................................................................................................................................. 5

6 Apparatus .......................................................................................................................................................... 6

7 Procedure .......................................................................................................................................................... 7

7.1 Preparation of solutions ............................................................................................................................... 7

7.1.1 Dimethylglyoxime test solution ................................................................................................................. 7

7.1.2 Artificial sweat solution ............................................................................................................................... 7

7.1.3 Dithiooxamide test solution ........................................................................................................................ 7

7.1.4 Sodium acetate buffer solution .................................................................................................................. 8

7.1.5 Degreasing solution ....................................................................................................................................... 8

7.2 Sample preparation — Cleaning of the surfaces to be tested ......................................................... 8

7.3 Test procedure ................................................................................................................................................. 8

7.4 Testing of interlayers or substrates under outer coatings — Abrasion of surfaces ............... 9

8 Interpretation of results ............................................................................................................................. 10

9 Test report ....................................................................................................................................................... 10

Bibliography ................................................................................................................................................................. 12

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kSIST-TP FprCEN/TR 12471:2021
FprCEN/TR 12471:2021 (E)
European foreword

This document (FprCEN/TR 12471:2021) has been prepared by Technical Committee CEN/TC 347

“Methods for analysis of allergens”, the secretariat of which is held by SNV.
This document is currently submitted to the Vote on TR.
This document will supersede CR 12471:2002.
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kSIST-TP FprCEN/TR 12471:2021
FprCEN/TR 12471:2021 (E)
Introduction

This document provides a completely revised and restructured edition of CR 12471:2002 “Screening

tests for the presence of nickel on alloys and coatings in articles that come into direct and prolonged

contact with the skin”.

This document has been prepared for the detection of nickel release. The described method is cost-

effective. It has particular relevance in relation to nickel contact dermatitis. In order to decrease the

incidence of nickel contact dermatitis, the European Commission introduced in 1994 the Nickel

Directive (94/27/EC), which specified a limit value for nickel content in articles inserted into pierced

parts of the human body and a limit value for nickel release from articles intended to come into direct

and prolonged contact with the skin.

The Nickel Directive has been replaced by REACH regulation (EC) No 1907/2006 in 2006. According to

REACH regulation Annex XVII, entry no 27, the nickel release for articles inserted into pierced parts of

the human body, has to be less than 0,2 µg/cm /week, whereas for articles intended to come into direct

and prolonged contact with the skin, it is 0,5 µg/cm /week or less.

European Standard EN 1811, “Reference test method for release of 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”, is used to determine whether such articles are in compliance with the

Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH), Annex XVII,

entry no 27, as amended.
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kSIST-TP FprCEN/TR 12471:2021
FprCEN/TR 12471:2021 (E)
1 Scope

This document provides a screening test based upon the use of dimethylglyoxime for detecting the

presence of nickel in articles that are inserted into pierced parts of the human body and those that are

intended to come into direct and prolonged contact with the skin.

This screening test is suitable for manufacturers and importers as a qualitative method for detecting the

presence of nickel in articles.

NOTE The reference method for the measurement of nickel release is EN 1811, or for spectacle frames and

sunglasses, EN 16128.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

EN ISO 3696, Water for analytical laboratory use - Specification and test methods (ISO 3696)

3 Terms and definitions
No terms and definitions are listed in this document.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
4 Principle

The method is based on the formation of a red coloured metal complex when nickel ions react with a

solution of dimethylglyoxime in the presence of ammonia.

In order to increase the sensitivity of the screening test, pre-treatment with artificial sweat and heat is

used to induce corrosion of the surface, simulating the influence of sweat when the article is in contact

with the skin. This screening method provides a result in a short time.
5 Reagents
All reagents should be of pro analysis grade or better.
5.1 Deionized water, according to EN ISO 3696, grade 2.
5.2 Ammonia solution, 10 % ammonia.

This solution may be prepared from a more concentrated ammonia solution, for example, one with a

mass fraction of 24 % or 30 % NH .
5.3 Sodium chloride, NaCl.
5.4 DL-Lactic acid, CH CHOHCOOH, > 88 % (m/m).
5.5 Urea, CO(NH ) .
2 2
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kSIST-TP FprCEN/TR 12471:2021
FprCEN/TR 12471:2021 (E)

5.6 Dimethylglyoxime, C H N O , 99 % or test strips (5.8) containing dimethylglyoxime.

4 8 2 2
5.7 Ethanol, C H OH, > 95 % (V/V).
2 5
5.8 Sodium hydroxide, pellets, purity ≥ 98 %, anhydrous.
5.8.1 Preparation of 1 M sodium hydroxide solution:

Weigh 4 g ± 0,01 g sodium hydroxide (5.8), transfer to a 100 ml beaker and add 50 ml deionized

water (5.1). Stir and cool to room temperature. Transfer the solution to a 100 ml volumetric flask and

make up to volume with deionized water (5.1).
Alternatively, it is possible to use 1 M ready-to-use solution.
5.8.2 Preparation of 0,1 M sodium hydroxide solution:

Transfer 25 ml of the 1 M sodium hydroxide solution (5.8.1) to a 250 ml volumetric flask and make up

to volume with deionized water (5.1).
Alternatively, it is possible to use 0,1 M ready-to-use solution.
5.9 Hydrochloric acid, 32 % (m/m).
5.9.1 Preparation of 0,1 M hydrochloric acid:

Transfer 1 ml hydrochloric acid (5.9) to a 100 ml volumetric flask and make up to volume with

deionized water (5.1).
Alternatively, it is possible to use 0,1 M ready-to-use solution.

5.10 Sodium dodecyl sulfate or sodium alkyllauryl sulfate or another surface-active anionic

detergent.

Additionally, the following reagents are required for the test with dithiooxamide (7.3.8):

5.11 Dithiooxamide, C H N S .
2 4 2 2
5.12 Sodium acetate trihydrate, C H NaO ·3H O
2 3 2 2
5.13 Acetic acid, glacial acetic acid, C H O .
2 4 2
6 Apparatus
6.1 Appropriate laboratory apparatus.

6.2 Flat-bottomed dish, made of glass or another non-metallic material. Not required for the pre-

test.
6.3 Graduated pipette, volume 50 µl.
6.4 Cotton-woo
...

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