SIST EN 16128:2025
(Main)Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release
Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release
This document specifies the reference method for the testing of spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used 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·cm−2·week−1 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 near-vision spectacles, sunglasses and spectacle frames used for eye and face protection.
NOTE The reference method for articles apart from spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection is specified in EN 1811.
Augenoptik - Referenzverfahren für die Bestimmung der Nickellässigkeit von Brillenfassungen und Sonnenbrillen
Dieses Dokument legt das Referenzverfahren für die Prüfung der Nickellässigkeit von Brillenfassungen, Nah-Fertigbrillen, Sonnenbrillen sowie Brillenfassungen fest, die als Augen- und Gesichtsschutz angewendet werden.
Das Referenzverfahren unterstützt den Nachweis der Einhaltung des in der Europäischen Verordnung festgelegten Grenzwerts für die Nickellässigkeit von 0,5 µg·cm−2·Woche−1.
Das Referenzverfahren umfasst die in Bild 1 dargestellten und in Abschnitt 4 beschriebenen Verfahrensschritte.
Dieses Dokument gilt für diejenigen Teile von Metall-Brillenfassungen sowie diejenigen Metallteile von Kombinations-Brillenfassungen, die bestimmungsgemäß in direkten und länger dauernden Kontakt mit der Haut des Trägers kommen. Dieses Dokument gilt ebenfalls für die entsprechenden Metallteile von Nah-Fertigbrillen, Sonnenbrillen sowie Brillenfassungen zum Augen- und Gesichtsschutz.
ANMERKUNG Das Referenzverfahren für alle Produkte mit Ausnahme von Brillenfassungen, Nah-Fertigbrillen, Sonnenbrillen und Brillenfassungen 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
Le présent document spécifie la méthode d’essai de référence pour la libération du nickel par les montures de lunettes, les lunettes prémontées pour vision de près, les lunettes de soleil et les montures de lunettes utilisées 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·cm−2·semaine−1 fixée par le Règlement européen.
La méthode de référence implique les étapes de mode opératoire présentées sur 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 prémontées pour vision de près, les lunettes de soleil et les montures de lunettes utilisées pour la protection des yeux et du visage.
NOTE La méthode de référence pour les articles autres que les montures de lunettes, les lunettes prémontées pour vision de près, les lunettes de soleil et les montures de lunettes utilisées pour la protection des yeux et du visage, est spécifiée dans l’EN 1811.
Očesna optika - Referenčna preskusna metoda za ugotavljanje sproščanja niklja iz okvirjev očal in sončnih očal
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2025
Nadomešča:
SIST EN 16128:2016
Očesna optika - Referenčna preskusna metoda za ugotavljanje sproščanja niklja iz
okvirjev očal in sončnih očal
Ophthalmic optics - Reference method for the testing of spectacle frames and
sunglasses for nickel release
Augenoptik - Referenzverfahren für die Bestimmung der Nickellässigkeit von
Brillenfassungen und Sonnenbrillen
Optique ophtalmique - Méthode d'essai de référence relative à la libération du nickel par
les montures de lunettes et les lunettes de soleil
Ta slovenski standard je istoveten z: EN 16128:2025
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 16128
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2025
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN 16128:2015
English Version
Ophthalmic optics - Reference method for the testing of
spectacle frames and sunglasses for nickel release
Optique ophtalmique - Méthode d'essai de référence Augenoptik - Referenzverfahren für die Bestimmung
relative à la libération du nickel par les montures de der Nickellässigkeit von Brillenfassungen und
lunettes et les lunettes de soleil Sonnenbrillen
This European Standard was approved by CEN on 8 September 2025.
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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 16128:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Principle . 8
5 Selection of test samples . 9
6 Simulation of wear and corrosion . 10
6.1 Preparation of test samples . 10
6.2 Procedure. 11
7 Coating test . 11
7.1 General . 11
7.2 Apparatus and consumables . 12
7.3 Preparation of test samples for the coating test . 13
7.3.1 Parts to be tested . 13
7.3.2 Dismantling and/or cutting and/or masking . 13
7.3.3 Determination of test area . 15
7.3.4 Preparation of electrical contact area . 15
7.4 Preparation of saline solution . 15
7.5 Procedure. 15
7.5.1 Preparation of the electro-chemical cell . 15
7.5.2 Insertion and connection of the test part in the electro-chemical cell . 16
7.5.3 Determination of open circuit potential and measurement of electrochemical impedance
of test samples . 16
7.5.4 Calibration and verification of the equipment . 17
7.6 Calculation of results . 17
7.6.1 General . 17
7.6.2 Criteria for pass or fail of the test sample . 17
7.7 Test report . 17
8 Release of nickel and its quantitative analytical detection (migration test) . 19
8.1 General . 19
8.2 Apparatus and consumables . 19
8.3 Preparation of test samples for the migration test . 21
8.3.1 Parts to be tested – general . 21
8.3.2 Small parts to be tested . 21
8.3.3 Guidance on selection of test areas on the parts to be tested . 21
8.3.4 Dismantling and degreasing . 22
8.4 Procedure. 22
8.4.1 Preparation of test paper including determination of its area . 22
8.4.2 Preparation of artificial sweat solution . 23
8.4.3 Applying artificial sweat solution to the test paper and attaching it to the test sample . 24
8.4.4 Blank sample . 25
8.4.5 Incubation of test sample with test paper attached (release of nickel into paper) . 25
8.4.6 Retrieval of the test paper from the test samples . 25
8.4.7 Analysis of the test papers for nickel . 26
8.5 Calculation of migration test results . 27
8.6 Interpretation of migration test results . 28
8.6.1 General . 28
8.6.2 Assessment of compliance . 28
8.6.3 Retesting after a fail result with the migration test . 29
8.7 Test report . 29
Annex A (informative) Examples of mounting test samples in the EN 12472 tumbling barrel. 31
Annex B (normative) Measuring device and identifying where to test sides . 32
Annex C (informative) Cutting and masking of test samples (Coating test) . 38
Annex D (informative) Quality control material for the coating test . 42
Annex E (normative) Selection of test areas and application of the test paper (Migration test) . 43
Bibliography . 49
European foreword
This document (EN 16128:2025) has been prepared by Technical Committee CEN/TC 170 “Ophthalmic
optics”, the secretariat of which is held by DIN.
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 April 2026, and conflicting national standards shall be
withdrawn at the latest by April 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 16128:2015.
— Clause 4 has been modified to give a better scientific explanation of why a sample that fails the
coating test might pass the migration test. It also states that the coating test is not a screening test
since a pass allows a product to be labelled as compliant with REACH. A revised flowchart (Figure 1)
reinforces this. The warning about taking particular attention over handling samples to avoid
additional damage has been reinforced;
— Clause 5 emphasizes that if a sample fails the coating test, then all parts of the sample have to be
tested with the migration test, not just the part that failed;
— Clause 6 notes that the lenses are needed in the frame to protect the groove during the simulated
wear and corrosion procedure. Although it applies to EN 12472, new Annex A provides illustrations
of mounts that can be used to hold sample frames in the tumbling barrel;
— Clauses 7 and 8 refer to the new normative Annex B for advice on where to test sides. Both
recommend that the test or dummy lenses are kept in the frame for the tests;
— More detailed advice on where to mask frames before the coating test has been provided in Clause 7.
The new quality control samples are mentioned in the new Annex D. Photographic records of the
samples are now required in the test report;
— Clause 8 now permits the use of a hermetically-sealed cabinet and laboratory oven to be used for the
migration process as well as a climate chamber. The concentration of the control solution has been
doubled and the volume halved, to avoid overloading the piece of test paper, which is suggested to
be 10 % larger. Again, photographic records of the samples are now required in the test report;
— Annexes B, C and D have photographic figures to illustrate sample preparation since they give better
clarity than drawings. The examples pictured provide no manufacturer markings and are in no way
intended to promote a particular manufacturer or style;
— Annex E has been revised to recommend folding of the sealing film over the test or dummy lenses
rather than wrapping around the rim.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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