EN 1811:2011
(Main)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
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
This European Standard specifies a method for simulating the release of nickel from all post assemblies which are inserted into pierced ears and other pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin in order to determine whether such articles are in compliance with the Commission Regulation (EC) No 552/2009 amending Regulation (EC) No 1907/2006 on REACH as regards Annex XVII.
Spectacle frames and sunglasses are excluded from the scope of this European Standard.
NOTE Spectacle frames and sunglasses are subject to the requirements of EN 16128:2011 which provides an unchanged re-publication of the technical requirements that had previously been specified in EN 1811:1998, but restricted in scope to apply only to spectacle frames and sunglasses.
Referenzprüfverfahren zur Bestimmung der Nickellässigkeit von sämtlichen Stäben, die in durchstochene Körperteile eingeführt werden und Erzeugnissen, die unmittelbar und länger mit der Haut in Berührung kommen
Diese Europäische Norm legt ein Verfahren fest, um die Nickellässigkeit von sämtlichen Stäben, die in durchstochene Ohren und in andere durchstochene Teile des menschlichen Körpers eingeführt werden sowie von Erzeugnissen, die unmittelbar und länger mit der Haut in Berührung kommen, zu bestimmen, um festzustellen, ob diese Erzeugnisse der Verordnung Nr. 552/2009, entsprechen, die die Verordnung (EG) Nr. 1907/2006 des Europäischen Parlaments und des Rates REACH, Anhang XVII, geändert hat.
Brillenfassungen und Sonnenbrillen sind von dem Anwendungsbereich dieser Europäischen Norm ausgeschlossen.
ANMERKUNG Brillenfassungen und Sonnenbrillen unterliegen den Anforderungen von EN 16128:201x, welche eine ungeänderte Neupublikation der technischen Anforderungen enthält, die ursprünglich in EN 1811:1998 enthalten waren, im Anwendungsbereich jedoch eingeschränkt auf Brillenfassungen und Sonnenbrillen ist.
Méthode d'essai de référence relative à la libération du nickel par les assemblages de tiges qui sont introduites dans les parties percées du corps humain et les produits destinés à entrer en contact direct et prolongé avec la peau
La présente Norme européenne spécifie une méthode pour simuler la libération du nickel par tous les assemblages de tiges insérés dans les oreilles percées et d’autres parties percées du corps humain et les articles destinés à venir en contact direct et prolongé avec la peau dans le but de déterminer si ces articles sont conformes au Règlement (CE) n° 1907/2006 du Parlement européen et du Conseil (REACH), en ce qui concerne le n° 27 de l'Annexe XVII. Les montures de lunettes et les lunettes de soleil sont exclues du domaine d’application de la présente Norme européenne. NOTE Les montures de lunettes et les lunettes de soleil sont soumises aux exigences de l’EN 16128:2011 qui est une réédition inchangée des exigences techniques qui ont été préalablement spécifiées dans l’EN 1811:1998, mais dont le domaine d’application est uniquement limité aux montures de lunettes et aux lunettes de soleil.
Primerjalna preskusna metoda za sproščanje niklja iz izdelkov, vstavljenih v prebodene dele človeškega telesa, in izdelkov, ki so v neposrednem in daljšem stiku s kožo
Ta evropski standard določa metodo za simulacijo sproščanja niklja iz vseh izdelkov, vstavljenih v prebodene dele človeškega telesa, in izdelkov, ki so v daljšem neposrednem stiku s kožo, da se določi, ali so ti izdelki v skladu z Evropsko direktivo 76/769/EGS, kot jo spreminjata direktivi 94/27/ES in 2004/96/ES. PRIPOMBA O PRIPRAVI OSNUTKA: CEN/TC 347/TG 1, ki je obravnavan v končni sprejeti odločitvi Evropske komisije, podpira vključitev naslednjega besedila v področje uporabe tega standarda: Okvirji očal in sončna očala so izključeni s področja uporabe tega evropskega standarda.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2011
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SIST EN 1811:1999
SIST EN 1811:1999+A1:2008
3ULPHUMDOQDSUHVNXVQDPHWRGD]DVSURãþDQMHQLNOMDL]L]GHONRYYVWDYOMHQLKY
SUHERGHQHGHOHþORYHãNHJDWHOHVDLQL]GHONRYNLVRYQHSRVUHGQHPLQGDOMãHP
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Reference test method for release of nickel from post assemblies which are inserted into
pierced parts of the human body and products intended to come into direct and
prolonged contact with the skin
Referenzprüfverfahren zur Bestimmung der Nickellässigkeit von sämtlichen Stäben, die
in durchstochene Körperteile eingeführt werden und Produkten, die unmittelbar und
länger mit der Haut in Berührung kommen
Méthode d'essai de référence relative à la libération du nickel par les assemblages de
tiges qui sont introduites dans les parties percées du corps humain et les produits
destinés à entrer en contact direct et prolongé avec la peau
Ta slovenski standard je istoveten z: EN 1811:2011
ICS:
39.060 Nakit Jewellery
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 1811
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2011
ICS 39.060 Supersedes EN 1811:1998+A1:2008
English Version
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
Méthode d'essai de référence relative à la libération du Referenzprüfverfahren zur Bestimmung der Nickellässigkeit
nickel par les assemblages de tiges qui sont introduites von sämtlichen Stäben, die in durchstochene Körperteile
dans les parties percées du corps humain et les produits eingeführt werden und Erzeugnissen, die unmittelbar und
destinés à entrer en contact direct et prolongé avec la peau länger mit der Haut in Berührung kommen
This European Standard was approved by CEN on 5 February 2011.
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-CENELEC 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-CENELEC Management Centre has the same
status as the official versions.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1811:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .4
Introduction .5
1 Scope .6
2 Normative references .6
3 Terms and definitions .6
4 Principle of the procedure .7
5 Reagents .7
6 Apparatus .8
7 Samples .9
7.1 Sample area .9
7.1.1 Definition of sample area .9
7.1.2 Determination of sample area .9
7.1.3 Masking of areas other than sample area .9
7.2 Sample degreasing before testing .9
7.3 Quality control samples .9
8 Procedure . 10
8.1 Preparation of test solution . 10
8.2 Release procedure . 10
8.3 Determination of nickel . 11
8.3.1 General . 11
8.3.2 Calibration solutions . 11
8.3.3 Detection limit and quantification limit . 11
8.3.4 Number of test samples . 11
8.3.5 Number of replicate measurements. 11
8.4 Blank tests . 11
9 Calculations . 11
9.1 Nickel release . 11
9.2 Interpretation of results . 12
9.2.1 General . 12
9.2.2 Assessment of non-compliance . 12
9.2.3 Uncertainty budget . 13
10 Test report . 13
Annex A (informative) Expanded measurement uncertainty of the test procedure and compliance
assessment . 14
Annex B (normative) Requirements for quality control material . 16
Annex C (normative) Requirements for preparation of 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 prior to nickel testing . 18
C.1 General . 18
C.2 Requirements and principle . 18
C.3 Determination of the nickel release test method . 18
C.4 Determination of surfaces coming into direct and prolonged contact with the skin or
pierced parts of the body . 18
C.4.1 Procedures for homogeneous and inhomogeneous articles . 18
C.4.2 Jewellery products . 20
C.4.3 Other articles such as textiles, footwear, garments, leather goods and mobile phones . 25
C.5 Methods of determining the surface areas . 26
C.5.1 Surface area measurements . 26
C.5.2 Minimum surface area . 26
C.5.3 Simplification of surface area determination using common shapes of consumer
products . 26
C.6 Testing apparatus prior to nickel release testing . 26
Annex D (informative) Articles made from composite materials . 28
Bibliography . 29
Foreword
This document (EN 1811:2011) has been prepared by Technical Committee CEN/TC 347 “Methods for
analysis of allergens”, the secretariat of which is held by DS.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by September 2011, and conflicting national standards shall be
withdrawn at the latest by March 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document, together with EN 16128:2011, supersedes EN 1811:1998 +A1:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
This document supports essential requirements of Commission Regulation (EC) No 1907/2006 (REACH) of
the European Parliament and the Council.
List of the significant technical changes that have been made in this new version of EN 1811 in comparison
with the former edition EN 1811:1998+A1:2008:
The scope of the former European Standard was divided: EN 1811:2011 is applicable for all products but
spectacle frames and sunglasses; EN 16128:2011 is applicable for spectacle frames and sunglasses;
List of the significant technical changes of EN 1811:2011 as compared to the former European Standard:
• The scope was expanded to include all post assemblies which are inserted into pierced parts of the
human body;
• The preparation of the test solution was tested and changed;
• The correction factor was eliminated and the concept of measurement uncertainty introduced;
• The Standard contains a new normative Annex C on the preparation of articles prior to nickel testing;
EN 16128:2011 is technically unchanged as compared to the former European Standard
EN 1811:1998+A1:2008.
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, Croatia, 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 the United Kingdom.,
Introduction
Adverse skin reaction to nickel has been known for many decades. Nickel is the most frequent cause of
contact allergy in Europe, and 10 % to 20 % of the patch tested female population and 1 % to 3 % of the patch
tested male population are allergic to nickel. Skin absorption of nickel ions, which are released from some
nickel-containing materials which are inserted into pierced ears or other pierced parts of the human body or
which are in direct and prolonged contact with the skin, causes sensitisation. Further exposure to soluble
nickel salts results in allergic contact dermatitis. It is known that sensitisation to nickel requires higher
exposure levels than does the elicitation in already sensitised individuals. There is a large variation in the
degree of sensitivity to nickel between i
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