SIST EN 1811:2011/kFprA1:2015

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

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

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

General Information

• Status: Not Published
• Public Enquiry End Date: 09-Jun-2015
• ICS: 39.060 - Jewellery
• Technical Committee: KDS - Cosmetics, chemical disinfectants and surface active agents
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 25-Aug-2016
• Due Date: 30-Aug-2016
• Completion Date: 25-Aug-2016
• Directive: 1907/2006 - Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
• Mandate: M/414 - M/414 standardisation mandate addressed to CEN for revision of methods of analysis to detect the release of nickel from products intended to come into direct and prolonged contact with the skin (revision of the standard method EN 1811:1998).
• Ref Project: EN 1811:2011/FprA1:2015 - 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

Relations

• Consolidated By: SIST EN 1811:2011+A1:2015 - 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: 18-Jan-2023
• Amends: SIST EN 1811:2011 - 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
• Effective Date: 01-May-2015
• Consolidated By: SIST EN 1811:2011+A1:2015 - 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: 19-Jan-2023
• Consolidated By: SIST EN 1811:2011+A1:2015 - 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: 01-Oct-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 1811:2011/kFprA1:2015
01-maj-2015
3ULPHUMDOQDSUHVNXVQDPHWRGD]DVSURãþDQMHQLNOMDL]L]GHONRYYVWDYOMHQLKY
SUHERGHQHGHOHþORYHãNHJDWHOHVDLQL]GHONRYNLVRYQHSRVUHGQHPLQGDOMãHP
VWLNXVNRåR
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
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
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/FprA1:2015
ICS:
39.060 Nakit Jewellery
SIST EN 1811:2011/kFprA1:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 1811:2011/kFprA1:2015

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SIST EN 1811:2011/kFprA1:2015

EUROPEAN STANDARD
FINAL DRAFT
EN 1811:2011
NORME EUROPÉENNE

EUROPÄISCHE NORM
FprA1
February 2015
ICS 39.060
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 draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 347.

This draft amendment A1, if approved, will modify the European Standard EN 1811:2011. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.

This draft amendment was established by CEN 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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 European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1811:2011/FprA1:2015:2015 E
worldwide for CEN national Members.

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SIST EN 1811:2011/kFprA1:2015
EN 1811:2011/FprA1:2015 (E)
Foreword
This document (EN 1811:2011/FprA1:2015) 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 Unique Acceptance Procedure.
2

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SIST EN 1811:2011/kFprA1:2015
EN 1811:2011/FprA1:2015 (E)

1 Modifications to 9.2, Interpretation of results
Replace the header of 9.2.2 with "9.2.2 Conformity assessment"
Delete the existing text in 9.2.2.2 and replace it with the following:
"Because of the combined measurement uncertainty of 46 %, an article is non-compli
...