EN 1811:1998+A1:2008

Reference test method for release of nickel from products intended to come into direct and prolonged contact with the skin

This European Standard specifies a method for simulating the release of nickel from articles intended to come
into direct and prolonged contact with the skin in order to determine whether such items release nickel at a
rate greater than 0,5 µg/cm2/week.

Referenzprüfverfahren zur Bestimmung der Nickellässigkeit von Produkten die in direkten und länger andauernden Kontakt mit der Haut kommen

Diese Europäische Norm legt ein Verfahren fest, um die Nickelabgabe von Gegenständen, die dafür bestimmt sind, in direkten und länger andauernden Kontakt mit der Haut zu kommen, zu simulieren, und um zu bestimmen, ob die Nickelabgabe solcher Gegenstände größer als 0,5 µg/cm2/Woche ist.

Méthode d'essai de référence pour la libération du nickel par les produits qui sont destinés à venir en contact direct et prolongé avec la peau

La présente norme européenne spécifie une méthode pour simuler la libération du nickel par les articles venant en
contact direct et prolongé avec la peau dans le but de déterminer si ces produits libèrent du nickel à un taux
supérieur à 0,5 μg/ cm2/semaine.

Primerjalna preskusna metoda za sproščanje niklja iz izdelkov, ki so v neposrednem in daljšem stiku s kožo

General Information

• Status: Withdrawn
• Publication Date: 01-Apr-2008
• Withdrawal Date: 08-Mar-2011
• ICS: 39.060 - Jewellery
• Technical Committee: CEN/TC 347 - Methods for analysis of allergens
• Drafting Committee: CEN/TC 347 - Methods for analysis of allergens
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 09-Mar-2011
• Completion Date: 09-Mar-2011
• Directive: 2004/96/EC - Commission Directive 2004/96/EC amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of nickel for piercing post assemblies for the purpose of adapting its Annex I to technical progress
• Directive: 76/769/EEC - Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations
• Directive: 94/27/EC - Restrictions on the marketing and use of certain dangerous substances and preparations (Dir. 76/769/EEC 12th amendment)
• Mandate: M/004 - Mandate by CEN for a standard concerning the analysis for nickel and for nickel release
• Ref Project: SIST EN 1811:1999+A1:2008 - Reference test method for release of nickel from products intended to come into direct and prolonged contact with the skin

Relations

• Merged From: EN 1811:1998 - Reference test method for release of nickel from products intended to come into direct and prolonged contact with the skin
• Effective Date: 18-Jan-2023
• Replaced By: EN 1811:2011 - 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
• Effective Date: 08-Jun-2022
• Replaced By: EN 16128:2011 - 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
• Effective Date: 08-Jun-2022

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Reference test method for release of nickel from products intended to come into direct and prolonged contact with the skinMéthode d'essai de référence pour la libération du nickel par les produits qui sont destinés à venir en contact direct et prolongé avec la peauReferenzprüfverfahren zur Bestimmung der Nickellässigkeit von Produkten die in direkten und länger andauernden Kontakt mit der Haut kommen39.060NakitJewelleryICS:SIST EN 1811:1999+A1:2008en,fr,deTa slovenski standard je istoveten z:EN 1811:1998+A1:200801-julij-2008SIST EN 1811:1999+A1:2008SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1811:1998+A1
April 2008 ICS 39.060 Supersedes EN 1811:1998 English Version
Reference test method for release of nickel from products intended to come into direct and prolonged contact with the skin Méthode d'essai de référence pour la libération du nickel par les produits qui sont destinés à venir en contact direct et prolongé avec la peau
Referenzprüfverfahren zur Bestimmung der Nickellässigkeit von Produkten die in direkten und länger andauernden Kontakt mit der Haut kommen This European Standard was approved by CEN on 10 October 1998 and includes Amendment 1 approved by CEN on 4 February 2008.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36
B-1050 Brussels © 2008 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1811:1998+A1:2008: E

Statistical uncertainty of the test procedure and interpretation of results.10 Annex B (informative)
Rules for production and preparation of reference material.12 Annex C (informative)
Identification and determination of sample area; and coating of non-significant areas.14 C.1 Identification and determination of sample area.14 C.2 Coating of non-significant areas.14 Annex D (informative)
Articles made from materials that can release small amounts of nickel.15 Bibliography.16

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Clinical patch-testing of a small selection of nickel-containing alloys and coatings on nickel-sensitized persons indicates that high and low results achieved with the present analytical method correspond closely with patch-test reactivity. Moreover, a nickel release rate threshold of 0,5 µg/cm2/week has been set in European Parliament and Council Directive 94/27/EC (OJ No. L188 of 22.7.94). In order to ensure that articles yielding values near this figure are not unnecessarily excluded from European trade as a result of the difficulties inherent in the test method, particularly when applied to intricately-shaped articles, the measured release figures are multiplied by a factor of 0,1. Materials recognized as causing sensitisation to nickel would not become acceptable by use of this adjustment. Application of this standard is confidently expected to reduce significantly the development of allergic contact dermatitis due to nickel. Experience of its use and further epidemiological and clinical research may justify changes to test procedure and/or interpretation of the test result.
1 Scope This European Standard specifies a method for simulating the release of nickel from articles intended to come into direct and prolonged contact with the skin in order to determine whether such items release nickel at a rate greater than 0,5 µg/cm2/week.
2 Principle The item to be tested for nickel release is placed in an artificial sweat test solution for 1 week. The concentration of dissolved nickel in the solution is determined by atomic absorption spectrometry, inductively-coupled plasma spectrometry or other appropriate analytical method. The nickel release is expressed in micrograms per square centimetre per week (µg/cm2/week).
3 Reagents Except where indicated, all reagents shall be of recognized pro analysis, p.a., grade or better and shall be free of nickel.

5 Samples 5.1 Sample area 5.1.1 Definition of sample area Only the surface(s) of an item that comes into direct and prolonged contact with the skin shall be analyzed. In this standard such surfaces are defined as "sample area". 5.1.2 Determination of sample area Determination of the sample area (a) in square centimetres is achieved by marking the contour of the sample area assuming that the item is worn or used as intended (see Annex C). In order to achieve the required degree of analytical sensitivity, a minimum sample area of 0,2 cm2 shall be tested. If necessary, identical items may be treated together to obtain this minimum area.
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