EN 16128:2015

Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release

This European Standard specifies the reference method for the testing of spectacle frames, ready-to-wear spectacles, sunglasses and other items for eye and face protection for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg/cm2/week set forth by European Regulation.
The reference method involves the procedural steps shown in Figure 1 and described in Clause 4.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear spectacles, sunglasses and other items for eye and face protection.
NOTE   The reference method for articles apart from spectacle frames, ready-to-wear spectacles, sunglasses and other items for eye and face protection is specified in EN 1811.

Augenoptik - Referenzverfahren für die Bestimmung der Nickellässigkeit von Brillenfassungen und Sonnenbrillen

Diese Europäische Norm legt das Referenzverfahren für die Bestimmung der Nickellässigkeit von Brillen-fassungen, Fertigbrillen, Sonnenbrillen und anderen Produkten zum Augen- und Gesichtsschutz fest.
Das Referenzverfahren unterstützt den Nachweis der Einhaltung des in der Europäischen Verordnung festgelegten Grenzwerts von 0,5 µg/cm2/Woche für die Nickellässigkeit.
Das Referenzverfahren umfasst die in Bild 1 dargestellten und in Abschnitt 4 beschriebenen Schritte.
Dieses Dokument gilt für diejenigen Teile von Metall-Brillenfassungen sowie diejenigen Teile von Kombinations-Brillenfassungen, die bestimmungsgemäß in direkten und länger dauernden Kontakt mit der Haut des Trägers kommen. Dieses Dokument gilt weiterhin für die entsprechenden Metallteile von Fertigbrillen, Sonnenbrillen und anderen Produkten zum Augen- und Gesichtsschutz.
ANMERKUNG   Das Referenzverfahren für alle Produkte mit Ausnahme von Brillenfassungen, Fertigbrillen, Sonnen-brillen und anderen Produkten zum Augen- und Gesichtsschutz ist in EN 1811 festgelegt.

Optique ophtalmique - Méthode d'essai de référence relative à la libération du nickel par les montures de lunettes et les lunettes de soleil

La présente Norme européenne spécifie la méthode d'essai de référence pour la libération du nickel par les montures de lunettes, les lunettes pré-montées, les lunettes de soleil et autres articles pour la protection des yeux et du visage.
La méthode de référence soutient la démonstration de la conformité avec la valeur limite de libération du nickel de 0,5 µg/cm2/semaine fixée par le Règlement européen.
La méthode de référence implique les étapes illustrées à la Figure 1 et décrites à l'Article 4.
Le présent document s'applique aux parties des montures de lunettes en métal et aux parties en métal des montures de lunettes combinées destinées à venir en contact direct et prolongé avec la peau du porteur. Il s'applique également aux parties en métal pertinentes des articles pour les lunettes pré-montées, les lunettes de soleil et autres articles de protection pour les yeux et le visage.
NOTE   La méthode de référence pour les articles autres que les montures de lunettes, les lunettes pré-montées, les lunettes de soleil et autres articles de protection pour les yeux et le visage, est spécifiée dans l'EN 1811.

Očesna optika - Referenčna preskusna metoda za ugotavljanje sproščanja niklja iz okvirjev očal in sončnih očal

Ta dokument določa metodo za simulacijo sproščanja niklja iz delov okvirjev očal in sončnih očal, ki so v daljšem neposrednem stiku s kožo, za ugotavljanje, ali sproščajo nikelj s hitrostjo več kot 0,5 µg/cm2/teden.

General Information

• Status: Withdrawn
• Publication Date: 03-Nov-2015
• Withdrawal Date: 25-Oct-2025
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170/WG 8 - Nickel release testing of spectacle frames
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 22-Oct-2025
• Completion Date: 26-Oct-2025
• 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/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 16128:2016 - Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release

Relations

• Replaces: CEN/TS 16677:2014 - Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release
• Effective Date: 08-Jun-2022
• Replaces: 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: 17-Apr-2010
• Replaced By: EN 16128:2025 - Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release
• Effective Date: 23-Aug-2023

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Augenoptik - Referenzverfahren für die Bestimmung der Nickellässigkeit von Brillenfassungen und SonnenbrillenOptique ophtalmique - Méthode d'essai de référence relative à la libération du nickel par les montures de lunettes et les lunettes de soleilOphthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN 16128:2015SIST EN 16128:2016en,fr,de01-januar-2016SIST EN 16128:2016SLOVENSKI
STANDARDSIST-TS CEN/TS 16677:2014SIST EN 16128:20111DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16128
November
t r s w English Version
Ophthalmic optics æ Reference method for the testing of spectacle frames and sunglasses for nickel release Optique ophtalmique æ Méthode d 5essai de référence relative à la libération du nickel par les montures de lunettes et les lunettes de soleil
Augenoptik æ Referenzverfahren für die Bestimmung der Nickellässigkeit von Brillenfassungen und Sonnenbrillen This European Standard was approved by CEN on
s { September
t r s wä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
t r s w CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s x s t zã t r s w ESIST EN 16128:2016

Cutting and masking of test samples (Coating test) . 27 A.1 Fronts . 27 A.2 Sides (temples) . 28 Annex B (normative)
Selection of test areas and application of the test paper (Migration test) . 29 B.1 General . 29 B.2 Rims . 29 B.3 Bridge . 30 B.4 Brace bar . 31 B.5 Sides . 32 B.6 Trims . 34 Bibliography . 35
Formers (ISO 11380) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 model spectacle frame, ready-to-wear spectacles, sunglass or other item used for eye and face protection produced to a common design, using the same materials and surface treatment, and to which the scope of this document applies 3.2 test sample spectacle frame, ready-to-wear spectacles, sunglass or other item used for eye and face protection submitted for testing Note 1 to entry: Fronts or sides may be submitted separately for testing. 3.3 test part part of a test sample that is intended to come into direct and prolonged contact with the skin and is due to be tested Note 1 to entry: These parts are defined in 7.3.1 (for the coating test) and in 8.3.1 (for the migration test). SIST EN 16128:2016

Key a The coating test is not sensitive only to nickel ions, so a model can pass the migration test even though it failed the coating test. Figure 1 — Diagrammatic overview of the reference test method 6 Simulation of wear and corrosion 6.1 Preparation of test samples For spectacle frames, if not already fitted with dummy or demonstration lenses, the test samples shall be fitted with a pair of suitable organic lenses within the range of
« sá r r D to +1,00 D and with an edge thickness of between 1,5 mm and 2,5 mm. These test lenses shall be edged either in accordance with the manufacturer's electronic instructions or with a digitally controlled edging machine that uses the tracing made of the individual test sample or, where appropriate, using a mechanical former in accordance with EN ISO 11380ä The bevel angle of the edged lens shall be
s t r ¹
« t ¹
ª u ¹ for spectacle frames featuring a rim with a groove. For all test samples, sides and fronts shall be separated from each other. Removing end covers (side tips) from sides is optional. Unless they have a metal-bearing surface, nose pads shall be removed before the wear phase. Sides shall be dismantled from fronts, either by unscrewing the dowel (hinge) screw or by cutting the joint across the charniers. WARNING — Care shall be taken not to damage the coating on areas that are subsequently tested, particularly the coating near any cut. Ensure that all the separate test parts remain identified throughout all steps of the overall procedure. SIST EN 16128:2016

b cm2). NOTE 1 A metal strip with approximate dimensions of 2 mm thick, 6 mm wide, and 100 mm long is suitable. It is useful if the masking agent is coloured or fluorescent, to make the masked areas more visible. NOTE 2 Lacomit is the trade name of a suitable product.1) 7.2.2 Deionized water, according to EN ISO 3696, grade 3 or to European Pharmacopaeia, for rinsing and preparation of the saline solution (7.4). 7.2.3 Sodium chloride of recognized pro analysis, p.a., grade or better, for preparation of the saline solution (7.4). 7.2.4 Degreasing solution, Sodium Dodecyl Sulfate (SDS) at a concentration of 0,5 % in deionized water, to clean the test samples after cutting, etc. and before testing. An appropriately diluted, neutral, commercially available detergent may also be used. 7.2.5 Apparatus for preparation of 1 % saline solution in deionized water.
1) Lacomit is an example of a suitable product available commercially. This information is given for the convenience of users of this document and does not constitute an endorsement by CEN of this product. Equivalent products may be used if they can be shown to lead to the same results.
2) Gamry apparatus series 600 with EIS 300 software package is an example of a suitable product available commercially. This information is given for the convenience of users of this document and does not constitute an endorsement by CEN of this product.
b cm2. Therefore, the method involves a need for determination of the test area, which is the immersed but unmasked surface area of the test sample. Determine the test area to the nearest cm2. Direct measurement of surface area may be used; CAD data from the frame manufacturer and/or classical picture analyser software may be helpful. 7.3.4 Preparation of electrical contact area The following serve as the electrical contact areas: — for sides: either the end furthest from the joint, or the joint; — for fronts: the joint end of the lug that is not masked. Abrade the electrical contact area e.g. with a hand-held rotary model-making tool, file, or emery or silicon carbide paper, so that the organic coating is completely removed. Take care not to damage the coating outside the contact area during this process. NOTE Wear suitable protective equipment, if appropriate. 7.4 Preparation of saline solution Prepare a solution of saline by dissolving 10 g ± 0,1 g of Sodium Chloride (7.2.3) in 1 l of deionized water (7.2.2). Ensure that the saline solution is at 25 °C ± 5 °C. Prepare a fresh saline solution after 7 d. 7.5 Procedure 7.5.1 Preparation of the electro-chemical cell Wash the electro-chemical cell with deionized water (7.2.2) or with saline solution (7.4). Fill the electro-chemical cell with saline solution (7.4). Change the solution at least once on each day of testing. SIST EN 16128:2016

reading impedance (highest− SIST EN 16128:2016

b cm2, in scientific notation to two significant figures. Some models of potentiostat allow the operator to enter the surface area of the sample into the software before starting the measurement. This type of equipment is likely to report the impedance in
b cm2. If the equipment reports
b cm2 is obtained by multiplying the 2. In the latter case, multiplication is necessary because this is effectively a calculation for resistances in parallel, not series. 7.6.2 Criteria for pass or fail of the test sample Classify the test part as pass or fail. A pass is considered to be an impedance greater or equal to the threshold limit of 3,0 b 105
b cm2, while a fail is considered to be an impedance lower than the threshold limit. For each of the two test samples, each of the two sides and the front shall be tested separately, and each test part shall pass in order for the model to pass. NOTE 1 This threshold limit was established by round robin tests, in which the impedance was compared with the nickel release. The threshold limit has been chosen both to allow a margin of safety and to include an allowance for uncertainty of measurement. NOTE 2 A pass result indicates compliance with the migration limits specified in paragraph 1(b) and (c) of entry 27 of Annex XVII to the REACH regulation. Because it is a coating test, Electrochemical Impedance Spectroscopy gives a result that includes all metal ions, not just nickel ions. Therefore, a failed model could demonstrate conformity with the regulatory limit by submission to the migration test. 7.7 Test report The test report for each determination shall include at least the following information: a) identification of the model or the test sample(s), respectively, including source, date of receipt, description, and, optionally, the assigned identification number(s) or code(s); b) a reference to this document, i.e. EN 16128:2015; c) documentation (verbal description and, optionally, photographs) of the parts of the test sample(s) and their preparation, including whether or not the test samples were subjected to the simulation of wear and corrosion according to EN 12472, and including the size of the test areas, expressed in cm2; d) test result and a statement on compliance or non-compliance of the model to the threshold value; SIST EN 16128:2016

left side
front
Second test sample right side
left side
front
Overall test resultb (pass or fail): a Defined by whether the impedance per unit area is greater than or equal to, or less than the threshold given in 7.6. b Defined by: Pass – all test parts pass, Fail – any (or all) test part(s) fails. 8 Release of nickel and its quantitative analytical detection (migration test) 8.1 General The analysis for nickel released from a test sample into a test paper is based on extraction followed by ICP-OES 3), or ICP-MS 4) or GFAAS 5). The parts of models needing consideration are only those intended to come into direct and prolonged contact with the skin of the wearer, see 8.3.1. Test papers impregnated with a known amount of nickel are used as control samples to monitor the extraction and the analysis procedure. A blank sample shall be tested with every batch of test samples. The blank sample shall consist of a piece of test paper impregnated with artificial sweat solution, which would then be extracted and analysed for nickel. 8.2 Apparatus and consumables 8.2.1 Laboratory cellulose paper, of highly-absorbing type, with one side covered with polyethylene (PE), capable of being cut into fine strips of width 0,15 cm without fraying, and for whi
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