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

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
• ICS: 39.060 - Jewellery
• Technical Committee: CEN/TC 347 - Methods for analysis of allergens
• Drafting Committee: CEN/TC 347/WG 1 - Metals
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 19-May-2015
• Due Date: 07-Sep-2015
• Completion Date: 19-May-2015
• 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: 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

Relations

• Merged Into: 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
• Amends: 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: 26-Feb-2014

Overview

EN 1811:2011/FprA1:2015 is a CEN reference test method for measuring the release of nickel from post assemblies inserted into pierced parts of the human body and from articles intended for direct and prolonged contact with the skin. The standard defines a laboratory simulation to determine compliance with REACH restrictions (Commission Regulation (EC) No 552/2009 amending Annex XVII of REACH). Spectacle frames and sunglasses are excluded (see EN 16128:2011).

Key topics and technical requirements

• Scope of testing: All post assemblies for pierced ears and other pierced body parts, plus articles for prolonged skin contact (jewellery, metal components in wearables).
• Analytical procedure: Simulated extraction and measurement of nickel migration using validated laboratory methods; results expressed as µg/cm2/week.
• Limit values: Legal migration limits referenced are 0.5 µg/cm2/week and 0.2 µg/cm2/week (depending on article classification).
• Measurement uncertainty and conformity assessment:
  • An inter-laboratory study (ISO 5725) estimated a combined expanded measurement uncertainty (u_t,r) = 46%.
  • Because of this uncertainty, the amendment sets decision thresholds: articles are deemed non‑compliant only when measured nickel release ≥ 0.88 µg/cm2/week (for the 0.5 limit) or ≥ 0.35 µg/cm2/week (for the 0.2 limit).
  • A one-sided t-test with coverage factor k(α)=1.65 (significance 0.05) is applied for conformity decisions; distributions are treated as log‑normal for lower-limit regions.
• Annexes and guidance:
  • Annex A explains uncertainty, statistical decision rules and the derived thresholds.
  • References to ISO/IEC Guide 98-3 (GUM) and EURACHEM/CITAC guidance for uncertainty and compliance assessment.

Practical applications and users

• Who uses EN 1811:
  • Testing and calibration laboratories performing nickel release / nickel migration tests.
  • Manufacturers and designers of jewellery, body-piercing posts, wearables and metal accessories for material selection and supplier control.
  • Regulators, product safety officers and market surveillance authorities verifying REACH Annex XVII compliance.
  • Retailers and importers performing due diligence and pre-market testing.
• Typical uses:
  • Routine compliance testing against REACH nickel limits.
  • Supplier qualification and incoming inspection.
  • Root-cause analysis for nickel allergy complaints and material reformulation.
  • Supporting technical files for CE / market placement.

Related standards and guidance

• EN 16128:2011 - nickel requirements specifically for spectacle frames and sunglasses.
• ISO 5725 - inter-laboratory study methodology.
• ISO/IEC Guide 98-3 (GUM) and EURACHEM/CITAC Guides - measurement uncertainty and compliance assessment best practice.

Keywords: EN 1811:2011, nickel release testing, REACH Annex XVII, nickel migration, post assemblies, jewellery testing, measurement uncertainty, CEN.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2015
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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.
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
...