oSIST prEN 16128:2024
(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
Specification of 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 [Regulation (EC) No 1907/2006, REACH, in particular Commission Regulation (EC) No 552/2009 of 22 June 2009 amending regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,
Authorization and restriction of Chemicals (REACH) as regards Annex XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES].
The standard 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. It also applies to those relevant metal parts of ready-towear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection.
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
Očesna optika - Referenčna preskusna metoda za ugotavljanje sproščanja niklja iz okvirjev očal in sončnih očal
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2024
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: prEN 16128
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2024
ICS Will supersede 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 draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 170.
If this draft becomes a European Standard, 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.
This draft European Standard 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, 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.
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: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 16128:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Principle . 7
5 Selection of test samples . 8
6 Simulation of wear and corrosion . 9
6.1 Preparation of test samples . 9
6.2 Procedure . 10
7 Coating test . 10
7.1 General. 10
7.2 Apparatus and consumables . 11
7.3 Preparation of test samples for the coating test . 12
7.4 Preparation of saline solution . 14
7.5 Procedure . 14
7.6 Calculation of results . 16
7.7 Test report . 16
8 Release of nickel and its quantitative analytical detection (migration test) . 17
8.1 General. 17
8.2 Apparatus and consumables . 18
8.3 Preparation of test samples for the migration test . 19
8.4 Procedure . 21
8.5 Calculation of migration test results . 26
8.6 Interpretation of migration test results . 27
8.7 Test report . 27
Annex A (informative) Examples of mounting test samples in the EN 12472 tumbling barrel
................................................................................................................................................................... 29
Annex B (normative) Where to test sides . 30
B.1 A measuring device . 30
B.2 Conventional frames . 31
B.3 Wrap frames . 32
B.4 Practical steps . 34
B.5 Rationale for the choice of 35 mm . 34
B.6 Springy jointless sides . 35
Annex C (informative) Cutting and masking of test samples (Coating test) . 36
C.1 Fronts . 36
C.2 Sides (temples) . 39
Annex D (informative) Quality control material for the coating test . 40
Annex E (normative) Selection of test areas and application of the test paper (Migration test)
................................................................................................................................................................... 41
E.1 General . 41
E.2 Rims . 41
E.3 Bridge . 42
E.4 Brace bar . 43
E.5 Sides . 44
E.6 Trims and nose pads with metal-bearing surfaces . 46
E.7 Screws . 46
Bibliography . 47
European foreword
This document (prEN 16128:2024) has been prepared by Technical Committee CEN/TC 170 “Ophthalmic
optics”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 16128:2015.
EN 16128:2024 includes the following significant technical changes with respect to 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;
— 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 informative 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.
Introduction
This document has been prepared under Mandate M/448 issued by the European Commission in the
framework of Regulation (EC) No 1907/2006, REACH, in particular Commission Regulation
(EC) No 552/2009 of 22 June 2009 amending regulation (EC) No 1907/2006 of the European Parliament
and of the Council on the Registration, Evaluation, Authorization and restriction of Chemicals (REACH)
as regards Annex XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF
CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES.
The aim of the mandate was the development of a new method of analysis to detect the release of nickel
from spectacle frames and sunglasses.
The availability of the new reference method for the determination of the release of nickel will provide
the reliable framework to enforce the limit value for nickel release set forth by the European Regulation
-2 -1 2
of 0,5 μg·cm ·week (expressed as 0,5 µg/cm /week in the Regulation). It will ensure a uniform
application and control of the European legislation in all member states.
Harmonizing the test method for nickel release in all member states is vital with a view to protecting
effectively the health of the end consumer, that is, the spectacle wearer. Nickel allergy is still the most
frequent contact allergy in Europe and a significant health issue.
prEN 161
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.