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

This European Standard specifies a method for simulating the release of nickel from those parts of spectacle frames and sunglasses intended to come into direct and prolonged contact with the skin in order to determine whether they release nickel at a rate greater than 0,5 µg/cm2/week.
NOTE 1   This European Standard, EN 16128, has been prepared in reply to the European Commission's Mandate M/448 addressed to CEN. From the technical point of view, this European Standard 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.
NOTE 2   Users of this European Standard may wish to note that, also in reply to the European Commission's Mandate M/448, this European Standard is currently subject to review with the objective of developing a new standardized method to supersede this European Standard when the new method becomes available.
NOTE 3   Nickel release testing of products other than spectacle frames and sunglasses is specified in prEN 1811:2009.

Referenzprüfverfahren zur Bestimmung der Nickellässigkeit derjenigen Teile von Brillenfassungen und Sonnenbrillen, die bestimmungsgemäß unmittelbar und länger mit der Haut in Berührung kommen

Diese Europäische Norm legt ein Verfahren fest, um die Nickelabgabe derjenigen Teile von Brillenfassungen und Sonnenbrillen, die bestimmungsgemäß in direkten und länger andauernden Kontakt mit der Haut zu kommen, zu simulieren, und um zu bestimmen, ob ihre Nickelabgabe größer als 0,5 µg/cm2/Woche ist.
ANMERKUNG 1   Diese Europäische Norm, FprEN 16128, wurde vom CEN aufgrund des Mandats M/448 der Europäischen Kommission erstellt. In technischer Hinsicht handelt es sich bei dieser Europäischen Norm um eine unveränderte Neuherausgabe der technischen Anforderungen, die bisher in EN 1811:1998 enthalten waren, wobei jedoch der Anwendungsbereich auf die Anwendung auf Brillenfassungen und Sonnenbrillen eingeschränkt wurde.
ANMERKUNG 2   Die Anwender dieser Europäischen Norm werden darauf hingewiesen, dass diese Europäische Norm – ebenfalls aufgrund des Mandats M/448 der Europäischen Kommission – derzeit einer Überprüfung unterzogen wird. Das Ziel ist, ein neues genormtes Prüfverfahren zu entwickeln, das diese Europäische Norm ersetzen wird, sobald die Erarbeitung abgeschlossen wurde.
ANMERKUNG 3   Die Bestimmung der Nickellässigkeit von anderen Gegenständen als Brillenfassungen und Sonnen¬brillen ist in prEN 1811:2009 festgelegt.

Méthode d'essai de référence relative à la libération du nickel par les parties des montures de lunettes et lunettes de soleil destinées à entrer en contact direct et prolongé avec la peau

La présente Norme européenne spécifie une méthode pour simuler la libération du nickel par les parties des
montures de lunettes et lunettes de soleil destinées à entrer en contact direct et prolongé avec la peau dans
le but de déterminer si elles libèrent du nickel à un taux supérieur à 0,5 µg/cm2/semaine.
NOTE 1 La présente Norme européenne, EN 16128, a été élaborée en réponse au Mandat M/448 de la Commission
Européenne adressé au CEN. Du point de vue technique, cette Norme européenne correspond à la publication sans
modification des exigences techniques précédemment spécifiées dans l’EN 1811:1998, mais le domaine d’application a
été restreint pour s’appliquer uniquement aux montures de lunettes et lunettes de soleil.
NOTE 2 Les utilisateurs de la présente Norme européenne sont informés que la présente Norme européenne est
actuellement soumise à une révision, également en réponse au Mandat M/448 de la Commission Européenne, dans le but
d’élaborer une nouvelle méthode normalisée destinée à remplacer la présente Norme européenne dès qu’elle sera
disponible.
NOTE 3 Les essais de libération de nickel par d’autres produits que les montures de lunettes et lunettes de soleil sont
spécifiés dans l’EN 1811:2011.

Primerjalna preskusna metoda za sproščanje niklja iz tistih delov okvirjev očal in sončnih očal, ki so predvideni za neposredni in daljši stik s kožo

Ta evropski standard določa metodo za posnemanje sproščanja niklja iz tistih delov okvirjev očal in sončnih očal, ki so predvideni za neposredni in daljši stik s kožo, s katero se ugotavlja, ali sproščajo nikelj s hitrostjo, ki presega 0,5 µg/cm2/teden.
OPOMBA 1: Ta evropski standard FprEN 16128 je pripravljen kot odgovor na pooblastilo Evropske komisije M/448, namenjen CEN. S tehničnega vidika ta evropski standard zagotavlja nespremenjeno ponovno objavo tehničnih zahtev, predhodno določenih v EN 1811:1998, vendar je omejen glede obsega uporabe, tako da velja samo za okvire za očala in sončna očala.
OPOMBA 2: Uporabniki tega evropskega standarda lahko opazijo, da se ta evropski standard tudi kot odziv na pooblastilo Evropske komisije M/448 trenutno preučuje zato, da bi se razvila nova standardizirana metoda, ki bo nadomestila ta evropski standard, ko bo nova metoda na voljo.
OPOMBA 3: Preskušanje sproščanja niklja iz proizvodov, ki niso okvirji za očala in sončna očala, določa prEN 1811:2009.

General Information

• Status: Withdrawn
• Publication Date: 08-Mar-2011
• Withdrawal Date: 03-Nov-2015
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 04-Nov-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
• 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
• Mandate: M/448 - Standardisation mandate assigned to CEN concerning the revision of methods of analysis to detect the release of nickel from spectacle frames and sunglasses (Revision of EN 1811:1998)
• Ref Project: SIST 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

Relations

• Replaces: 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
• Effective Date: 08-Jun-2022
• Replaced By: EN 16128:2015 - Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release
• Effective Date: 17-Apr-2010

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.RReferenzprüfverfahren zur Bestimmung der Nickellässigkeit derjenigen Teile von Brillenfassungen und Sonnenbrillen, die bestimmungsgemäß unmittelbar und länger mit der Haut in Berührung kommenMéthode d'essai de référence relative à la libération du nickel par les parties des montures de lunettes et lunettes de soleil destinées à entrer en contact direct et prolongé avec la peauReference test method for release of nickel from those parts of spectacle frames and sunglasses intended to come into close and prolonged contact with the skin11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN 16128:2011SIST EN 16128:2011en,fr,de01-september-2011SIST EN 16128:2011SLOVENSKI
STANDARDSIST EN 1811:1999+A1:20081DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16128
March 2011 ICS 11.040.70 Supersedes EN 1811:1998+A1:2008English Version
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
Méthode d'essai de référence relative à la libération du nickel par les parties des montures de lunettes et lunettes de soleil destinées à entrer en contact direct et prolongé avec la peau
Referenzprüfverfahren zur Bestimmung der Nickellässigkeit derjenigen Teile von Brillenfassungen und Sonnenbrillen, die bestimmungsgemäß unmittelbar und länger mit der Haut in Berührung kommen This European Standard was approved by CEN on 9 January 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 worldwide for CEN national Members. Ref. No. EN 16128:2011: ESIST EN 16128:2011

Statistical uncertainty of the test procedure and interpretation of results . 11Annex B (informative)
Rules for production and preparation of reference material . 13Annex C (informative)
Identification and determination of sample area; and coating of non-significant areas. 15C.1Identification and determination of sample area . 15C.2Coating of non-significant areas . 15Annex D (informative)
Articles made from materials that can release small amounts of nickel . 16Bibliography . 17 SIST EN 16128:2011

NOTE 2 Users of this European Standard may wish to note that, also in reply to the European Commission's Mandate M/448, this European Standard is currently subject to review with the objective of developing a new standardized method to supersede this European Standard when the new method becomes available. NOTE 3 Nickel release testing of products other than spectacle frames and sunglasses is specified in EN 1811:2011.
2 Principle The parts to be tested for nickel release are 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. 3.1 Deionized and aerated water. Fill a tall-form 2-l beaker with deionized water, specific conductivity max. 1 µS/cm. Saturate with air by attaching a gas distribution tube (porosity 1) to a cork and positioning the lower end of the tube on the bottom of the beaker. Allow grease-free air to flow at a rate of 150 ml/min. for 30 min. 3.2 Sodium chloride. 3.3 DL-Lactic acid, ρ = 1,21 g/ml, >88 % (m/m). 3.4 Urea. 3.5 Ammonia solution, ρ = 0,91 g/ml, 25 % (m/m). 3.6 Dilute ammonia solution, 1 % (m/m). Transfer 10 ml of ammonia solution (3.5) into a 250-ml beaker containing 100 ml of deionized water. Stir and cool to room temperature. Transfer the solution to a 250-ml volumetric flask and make up to volume with deionized water.
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