SIST-TP CEN/TR 12471:2022

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 sceening test based upon the use of dimethylglyoxime to detect nickel release from 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.
The screening test is suitable for manufacturers and importers as a qualitative method for inspecting articles for nickel release.
NOTE     The reference method for the measurement of nickel release in 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

Dieses Dokument enthält einen Screening-Test basierend auf der Verwendung von Dimethylglyoxim zum Nachweis von Nickel in Gegenständen, die in durchstochene Teile des menschlichen Körpers eingeführt werden und die dazu bestimmt sind, in direkten und längeren Kontakt mit der Haut zu kommen.
Dieser Screening-Test ist für Hersteller und Importeure als qualitative Methode zum Nachweis der Anwesenheit von Nickel in Gegenständen geeignet.
ANMERKUNG   Das Referenzverfahren für die Messung der Nickelfreisetzung ist die EN 1811 bzw. für Brillengestelle und Sonnenbrillen die EN 16128.

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

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

Dokument zagotavlja presejalne preskuse, ki temeljijo na uporabi dimetilglioksima, za zaznavanje sproščanja niklja iz izdelkov, ki se vstavijo v prebodene dele človeškega telesa, in izdelkov, ki so v neposrednem in dolgotrajnem stiku s kožo.
Presejalni preskus je primeren za proizvajalce in uvoznike kot kvalitativna metoda za preverjanje sproščanja niklja iz izdelkov.
OPOMBA:   Primerjalna preskusna metoda za sproščanje niklja je v standardu EN 1811 oziroma za okvirje za očala in sončna očala v standardu EN 16128.

General Information

• Status: Published
• Public Enquiry End Date: 01-Dec-2021
• Publication Date: 17-Aug-2022
• ICS: 39.060 - Jewellery
• Technical Committee: KDS - Cosmetics, chemical disinfectants and surface active agents
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 21-Jun-2022
• Due Date: 26-Aug-2022
• Completion Date: 18-Aug-2022
• Ref Project: CEN/TR 12471:2022 - 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

Relations

• Replaces: SIST CR 12471:2004 - Screening tests for nickel release from alloys and coatings in items that come into direct and prolonged contact with the skin
• Effective Date: 01-Sep-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TP CEN/TR 12471:2022
01-september-2022
Nadomešča:
SIST CR 12471:2004
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: CEN/TR 12471:2022
ICS:
39.060 Nakit Jewellery
SIST-TP CEN/TR 12471:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 12471:2022

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SIST-TP CEN/TR 12471:2022


CEN/TR 12471
TECHNICAL REPORT

RAPPORT TECHNIQUE

February 2022
TECHNISCHER BERICHT
ICS 39.060 Supersedes 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 présence de nickel dans les Screeningverfahren für die Nickelabgabe aus
articles introduits dans les parties percées du corps Erzeugnissen, die in durchstochene Körperteile
humain et les produits destinés à entrer en contact eingeführt werden, und Erzeugnissen, die unmittelbar
direct et prolongé avec la peau und länger mit der Haut in Berührung kommen


This Technical Report was approved by CEN on 24 January 2022. 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.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 12471:2022 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST-TP CEN/TR 12471:2022

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 . 10
8 Interpretation of results . 10
9 Test report . 11
Bibliography . 12
2

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SIST-TP CEN/TR 12471:2022
CEN/TR 12471:2022 (E)
European foreword
This document (CEN/TR 12471:2022) has been prepared by Technical Committee CEN/TC 347
“Methods for analysis of allergens”, the secretariat of which is held by SNV.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CR 12471:2002.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
3

---------------------- Page: 5 ----------------------
SIST-TP CEN/TR 12471:2022
CEN/TR 12471:2022 (E)
Introduction
This document provides a completely revised and restructured edition of CR 12471:2002, Screening
tests for nickel release from alloys and coatings in items 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
2
the human body, has to be less than 0,2 µg/cm /week, whereas for articles intended to come into direct
2
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.
4

---------------------- Page: 6 ----------------------
SIST-TP CEN/TR 12471:2022
CEN/TR 12471:2022 (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:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
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 .
3
5.3 Sodium chloride, NaCl.
5.4 DL-Lactic acid, CH CHOHCOOH, > 88 % (m/m).
3
5.5 Urea, CO(NH ) .
2 2
5

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SIST-TP CEN/TR 12471:2022
CEN/TR 12471:2022 (E)
5.6 Dimethylglyoxime, C H N O , 99 % or test strips (6.8) 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-wool-tipped sticks (white cotton wool on
...

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.

---------------------- Page: 1 ----------------------
kSIST-TP FprCEN/TR 12471:2021

---------------------- Page: 2 ----------------------
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.

---------------------- Page: 3 ----------------------
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

2

---------------------- Page: 4 ----------------------
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.
3

---------------------- Page: 5 ----------------------
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
2
the human body, has to be less than 0,2 µg/cm /week, whereas for articles intended to come into direct
2
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.
4

---------------------- Page: 6 ----------------------
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 .
3
5.3 Sodium chloride, NaCl.
5.4 DL-Lactic acid, CH CHOHCOOH, > 88 % (m/m).
3
5.5 Urea, CO(NH ) .
2 2
5

---------------------- Page: 7 ----------------------
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
...