SIST-TS CEN/TS 16677:2014
(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 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 - Referenzprüfverfahren zur Bestimmung der Nickellässigkeit von Brillenfassungen und Sonnenbrillen
Dieses Dokument legt das Referenzverfahren für die Bestimmung der Nickellässigkeit von Brillenfassungen, 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
Le présent document spécifie la méthode d'essai de référence pour la libération du nickel par les montures de lunettes, les lunettes de vue, 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 indiquées 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 qui sont destinées à venir en contact direct et prolongé avec la peau du porteur. Il s'applique également aux parties en métal pertinentes des lunettes de vue, des lunettes de soleil et autres articles pour la protection des yeux et du visage.
NOTE La méthode de référence pour les articles autres que les montures de lunettes, les lunettes de vue, 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 referenčno preskusno metodo za ugotavljanje sproščanja niklja iz okvirjev očal in sončnih očal. Referenčna metoda omogoča dokazovanje skladnosti z mejno vrednostjo sproščanja niklja 0,5 μg/cm2/teden, ki je določena z evropskimi predpisi. Referenčna metoda vključuje postopkovne ukrepe, prikazane na sliki 1 in opisane v točki 4. Ta dokument velja za dele kovinskih okvirjev očal in kovinske dele okvirjev kombiniranih očal, ki so v neposrednem in dolgotrajnem stiku s kožo uporabnika. Ta dokument velja tudi za ustrezne kovinske dele konfekcijskih očal, sončnih očal in drugih pripomočkov za zaščito oči in obraza. OPOMBA Referenčna preskusna metoda za izdelke, ki niso okvirji očal, konfekcijska očala, sončna očala in drugi pripomočki za zaščito oči in obraza, je določena v standardu EN 1811.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TS CEN/TS 16677:2014
01-julij-2014
2þHVQDRSWLND5HIHUHQþQDSUHVNXVQDPHWRGD]DXJRWDYOMDQMHVSURãþDQMDQLNOMDL]
RNYLUMHYRþDOLQVRQþQLKRþDO
Ophthalmic optics - Reference method for the testing of spectacle frames and
sunglasses for nickel release
Augenoptik - Referenzprüfverfahren zur 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: CEN/TS 16677:2014
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST-TS CEN/TS 16677:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TS CEN/TS 16677:2014
TECHNICAL SPECIFICATION
CEN/TS 16677
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
May 2014
ICS 11.040.70
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 der
relative à la libération du nickel par les montures de lunettes Nickellässigkeit von Brillenfassungen und Sonnenbrillen
et les lunettes de soleil
This Technical Specification (CEN/TS) was approved by CEN on 15 March 2014 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 16677:2014 E
worldwide for CEN national Members.
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Contents Page
Foreword .4
Introduction .5
1 Scope .6
2 Normative references .6
3 Terms and definitions .6
4 Principle .7
5 Sampling and preparation of test samples .8
5.1 Selection of test samples .8
5.2 Preparation and conditioning of test samples .8
6 Simulation of wear and corrosion .9
7 Coating test .9
7.1 General .9
7.2 Apparatus and consumables .9
7.3 Preparation of test samples for coating test . 10
7.3.1 Parts to be tested . 10
7.3.2 Dismantling and/or cutting and/or masking . 11
7.3.3 Determination of test area . 12
7.3.4 Preparation of electrical contact area . 12
7.4 Preparation of saline solution . 13
7.5 Procedure . 13
7.5.1 Preparation of the electro-chemical cell . 13
7.5.2 Insertion and connection of the test part in the electro-chemical cell. 13
7.5.3 Determination of open circuit potential and measurement of electrochemical impedance
of samples . 14
7.5.4 Calibration of the potentiostat . 14
7.6 Calculation of results . 14
7.7 Test report . 15
8 Release of nickel and its quantitative analytical detection (migration test) . 15
8.1 General . 15
8.2 Apparatus and consumables . 16
8.3 Preparation of test samples for migration test . 17
8.3.1 Parts to be tested . 17
8.3.2 Guidance on selection of test areas on the parts to be tested . 18
8.3.3 Dismantling and degreasing . 18
8.4 Procedure . 18
8.4.1 Preparation of test paper including determination of its area . 18
8.4.2 Preparation of artificial sweat solution. 19
8.4.3 Applying artificial sweat to the test paper and attaching it to the test sample . 21
8.4.4 Incubation of test sample with test paper attached (release of nickel into paper) . 21
8.4.5 Retrieval of the test paper from the test samples . 22
8.4.6 Analysis of the paper for nickel present . 22
8.5 Calculation of results . 24
8.6 Interpretation of results . 25
8.6.1 General . 25
8.6.2 Assessment of non-compliance . 25
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8.7 Test report . 25
Annex A (informative) 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 wrapping (Migration test) . 29
B.1 Rims . 29
B.2 Bridge and brace bar . 30
B.3 Sides (temples) . 31
B.4 Wrapping with sealing film . 32
Bibliography . 33
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Foreword
This document (CEN/TS 16677:2014) has been prepared by Technical Committee CEN/TC 170 “Ophthalmic
optics”, the secretariat of which is held by DIN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: 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 the United Kingdom.
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CEN/TS 16677:2014 (E)
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 is the revision of the 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 from spectacle
frames and sunglasses will provide the reliable framework to enforce the limit value for nickel release of
2
0,5 µg/cm /week set forth by European Regulation. It will ensure a uniform application and control of the
European legislation in all member states.
Harmonising 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.
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1 Scope
This document 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
2
0,5 µg/cm /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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
EN 12472, Method for the simulation of wear and corrosion for the detection of nickel release from coated
items
EN ISO 3696:1995, Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
EN ISO 11380, Optics and optical instruments - Ophthalmic optics - Formers (ISO 11380)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
article
spectacle frame, ready-to-wear spectacles, sunglass or other item used for eye and face protection to which
the scope of this document applies
3.2
test sample
spectacle frame, ready-to-wear spectacle, 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
that part of a test sample that is intended to come into direct and prolonged contact with the skin and shall 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).
3.4
test paper
piece of paper used for testing, at any stage of the procedure
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3.5
extraction solution
solution obtained after extracting the test paper
3.6
appropriate tool
tool enabling the procedure to be performed without causing contamination by nickel or other metal ions,
either from the material of the tool or deposits on it
Note 1 to entry: Such tools could be made from plastics, titanium, or stainless steels.
3.7
appropriate equipment
equipment enabling the procedure to be performed without causing contamination by nickel or other metal
ions, either from the material of the equipment or deposits on it
4 Principle
Following the simulation of wear and corrosion for coated test parts, according to the method specified in
EN 12472, the reference method comprises the following procedural steps:
1) Coating test, applicable only to test parts with an organic coating, based on Electrochemical Impedance
Spectroscopy (EIS) and specified in Clause 7; the coating test aims at demonstrating that the coating of
the test sample is of sufficient quality to prevent the release of nickel, thereby ensuring that the test
sample's nickel release does not exceed the regulatory limit. The coating test is, however, sensitive to all
ions, so an article may pass the migration test even though it failed the coating test.
2) Migration test for nickel ion release, specified in Clause 8; the migration test makes provision for
quantitative testing for the amount of nickel released, to determine whether or not the article's nickel
release exceeds the regulatory limit. The migration test comprises two steps: Release of nickel by
artificial sweat into a test paper and the subsequent quantitative analytical detection of the nickel released
into the paper.
For an article that failed the coating test, either new test samples or, subject to the requirements of the person
ordering the test, the original test samples may be subjected to the migration test.
Figure 1 illustrates the procedure.
Requirements for sampling and guidance as to which parts of the articles shall be subject to testing (the test
parts) are given in 5.1, and in 7.3.1 (for the coating test) and 8.3.1 (for the migration test).
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a
The coating test is sensitive to all ions, so an article may pass the migration test even though it failed the coating test.
Figure 1 — Flowchart
5 Sampling and preparation of test samples
5.1 Selection of test samples
Two specimens of each article to be tested shall be selected at random for either the coating or the migration
test.
The selected specimens shall be identified as test sample 1 and test sample 2.
Subject to the agreement by the person ordering the test, test samples used for the coating test can be tested
in a subsequent migration test, but not vice versa.
If a test sample is likely to be subjected to the migration test after the coating test, it shall be washed in
deionised water immediately after the coating test and allowed to dry to avoid corrosion from sodium chloride.
It is preferable that new test samples are used for the migration test.
Prior to performing the coating test (see Clause 7) and the migration test (see Clause 8), as applicable, all test
samples shall be prepared and conditioned as specified in 5.2, then be subjected to the simulation of wear
and corrosion as specified in EN 12472 (see Clause 6).
5.2 Preparation and conditioning 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 -1,00 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 11380. The bevel
angle of the edged lens shall be 120° -2° +3° for spectacle frames featuring a rim with a groove.
Sides and fronts shall be separated from each other, and end covers (side tips) removed from sides where
appropriate. Unless they have a metal-bearing surface, remove nose pads before the wear phase.
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Dismantling of sides from fronts may be done either by unscrewing the joint screw or by cutting the joint
across the charniers.
WARNING: Care shall be taken not to damage the coating on the frame on areas that are subsequently
tested, particularly the coating near the cut.
Ensure that all the separate test parts remain identified throughout all steps of the overall procedure.
6 Simulation of wear and corrosion
Prior to submission to the selected test, the test samples shall be subject to the method for simulation of wear
and corrosion according to EN 12472.
Fix fronts and sides separately onto the retaining system and slide into the rotating barrel.
When the accelerated wear and corrosion process is completed, remove the test samples. Gently swirl the
sample(s) for 2 min in degreasing solution at room temperature. Rinse thoroughly with de-ionised water.
Gently dry in a clean air stream or allow to dry on absorbent paper. After degreasing, handle the samples with
appropriate tools or clean laboratory gloves.
Remove lenses from fronts by unscrewing the closing block joint.
NOTE Pushing dummy lenses out is very likely to damage the coating, while the alternative test lenses specified in
EN ISO 12870 can be removed only by unscrewing.
Disassemble three-piece rimless fronts. Disassemble fronts of combination frames and remove any plastics
parts.
Then subject the test parts to the selected test: Coating test, see Clause 7, and/or migration test, see
Clause 8.
7 Coating test
7.1 General
The purpose of the coating test is to verify if the surface treatment of an article is able to limit the release of
metal ions (hence including nickel), in order to identify good quality coatings. Test samples that are not
identified as "pass" may be subjected to the migration test, see Clauses 4 and 5.
The parts of spectacle frames needing consideration are only those intended to come into direct and
prolonged contact with the skin of the wearer, see 7.3.1.
7.2 Apparatus and consumables
7.2.1 Masking agent, suitable for electroplating purposes and capable of electrically insulating the test part
from the saline solution. Application of more than one coat is acceptable, and may be preferable.
Test the masking agent to verify that it is suitable by using it to coat a metal rod without an organic coating
and show that the adhesion is good and impedance results are high (greater than 50 MΩ).
It is recommended that the masking agent be coloured or fluorescent, to make the masked areas more visible.
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1)
NOTE Lacomit is the trade name of a suitable product.
7.2.2 Deionised water, according to EN ISO 3696:1995, grade 3 or to Ph.Eur., for rinsing and preparation
of the saline solution (7.4).
7.2.3 Sodium chloride of recognised pro analysis, p.a., grade or better, for preparation of the saline
solution (7.4);
7.2.4 Degreasing solution, Sodium Dodecyl Sulphate (SDS) at a concentration of 2 % in deionised 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 deionised water.
7.2.6 Electro-chemical cell, made of glass, suitable for mounting firstly a Standard Calomel (SCE) or
Ag/AgCl Reference Electrode, secondly a Graphite or Platinum Counter Electrode and thirdly, the test part.
NOTE The recommended counter electrode is a high density pure graphite rod, approximately 6 mm in diameter.
7.2.7 Laboratory clamps, suitable for holding the (cut) test sample, as required to immerse the selected
area in electrolyte in the electro-chemical cell, but keeping the electrical contact area dry.
7.2.8 Potentiostat, having the ability to perform A.C. Electrochemical Impedance Spectroscopy (EIS) at
1 Hz and having a current sensitivity of better than 1 pA.
2)
NOTE An example of suitable apparatus is Gamry apparatus series 600 with EIS 300 software package.
7.2.9 Electrical clamps, e.g. small crocodile clips, capable of providing secure electrical contact with the
test sample, reference and counter electrodes.
7.2.10 Calibration (dummy) cell, usually supplied by the potentiostat manufacturer together with the
instrument, appropriate to test the potentiostat in the impedance range expected.
7.2.11 Appropriate tools, needed to perform the procedure. See 3.6 for the definition of "appropriate" tools.
To prevent possible contamination by nickel or other metal ions, clean all tools well before use.
7.2.12 Laboratory gloves, e.g. latex or PVC, but not cotton.
7.2.13 Faraday cage; either an earthed Faraday cage, aluminium foil or conductive cloth to house the
electro-chemical cell during measurement.
7.3 Preparation of test samples for coating test
7.3.1 Parts to be tested
See subclause 5.1 for sampling requirements.
For testing of articles with the coating test, the parts to be tested are:
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.
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a) the front, comprising the rims including the groove, the bridge and the brace bar (if applicable) but
excluding the pad arms and pad boxes, lugs and closing block joints;
b) sides (temples), including metal collets, but excluding the joints, a zone (ideally 10 mm) around the joints,
and areas intended to be protected by plastic end covers (tips).
For each of the two test samples, the front and the two sides shall be tested separately; all three parts shall
pass in order for the article to pass.
7.3.2 Dismantling and/or cutting and/or masking
7.3.2.1 General
Prior to submission to the coating test, the test sample shall have been subject to the method for simulation of
wear and corrosion according to EN 12472. See Clause 6.
Select and separate those parts (or areas) which are subject to testing from those that are not. This can be
achieved by one or more of the following:
a) dismantling (see 7.3.2.2);
b) cutting (see 5.2, 7.3.2.3 and Annex A);
c) masking (see 7.3.2.4 and Annex A).
Consider the need for preparing the electrical contact area (see 7.3.4) and for determination of surface area
(see 7.3.3) when deciding where to cut or which areas to mask. Masking any "complicated" details of the test
sample which would not come into direct and prolonged contact with the skin could simplify the determination
of surface area and/or enhance its precision.
Cutting of the test samples, to separate the parts (or areas) to be tested from those not to be tested, is
permissible, but should be avoided if at all possible.
NOTE Cutting can be avoided by masking all of the test sample except those parts (or areas) to be subjected to the
test.
CAUTION — If cutting is undertaken, great care shall be taken to avoid contamination of metal ions
e.g.
— from the base material;
— from metal particles getting underneath the masking;
— by damaging the organic coating that is near the cut and subsequently tested;
— metal on tools or fingers or workplace.
Ensure that all the separate parts of the test samples remain identified, e.g. test serial number, while not
physically touching or modifying them.
7.3.2.2 Dismantling
If not already removed for the simulation of wear and corrosion according to EN 12472, dismantle nose pads
from fronts.
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7.3.2.3 Cutting
Cut the frame by hand-sawing or cutting pliers.
Cut edges and any other areas of the parts to be tested that are not covered by an organic coating, other
those intended for use as electrical contact areas (see 7.3.4), will require masking. See 7.3.2.4 for
requirements regarding masking.
Ensure that cut edges are rounded in order to help get a good even coating of masking agent.
7.3.2.4 Masking
Gently swirl the test sample(s) for 2 min in degreasing solution (7.2.4) at room temperature. Rinse thoroughly
and carefully with de-ionised water (7.2.2) and gently dry in a clean air stream or allow to dry on absorbent
paper.
NOTE This cleaning stage is intended to remove plasticisers from packaging, extraneous grease and skin secretions
due to handling, but not any protective coatings.
After degreasing, handle the test samples with appropriate tools or clean laboratory gloves.
Masking can be done by dipping or painting/brushing. Whichever method is used, ensure that the resulting
masking film is much thicker
...
SLOVENSKI STANDARD
kSIST-TS FprCEN/TS 16677:2014
01-januar-2014
2þHVQDRSWLND5HIHUHQþQDSUHVNXVQDPHWRGD]DXJRWDYOMDQMHVSURãþDQMDQLNOMDL]
RNYLUMHYRþDOLQVRQþQLKRþDO
Ophthalmic optics - Reference method for the testing of spectacle frames and
sunglasses for nickel release
Augenoptik - Referenzprüfverfahren zur 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: FprCEN/TS 16677
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
kSIST-TS FprCEN/TS 16677:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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kSIST-TS FprCEN/TS 16677:2014
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kSIST-TS FprCEN/TS 16677:2014
TECHNICAL SPECIFICATION
FINAL DRAFT
FprCEN/TS 16677
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
February 2014
ICS 11.040.70
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 der
relative à la libération du nickel par les montures de lunettes Nickellässigkeit von Brillenfassungen und Sonnenbrillen
et les lunettes de soleil
This draft Technical Specification is submitted to CEN members for formal vote. It has been drawn up by the Technical Committee CEN/TC
170.
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 Technical Specification. It is distributed for review and comments. It is subject to change without notice
and shall not be referred to as a Technical Specification.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TS 16677:2014 E
worldwide for CEN national Members.
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Contents Page
Foreword .4
Introduction .5
1 Scope .6
2 Normative references .6
3 Terms and definitions .6
4 Principle .7
5 Sampling and preparation of test samples .8
5.1 Selection of test samples .8
5.2 Preparation and conditioning of test samples .9
6 Simulation of 2-years' wear .9
7 EIS method (coating test) .9
7.1 General .9
7.2 Apparatus and consumables . 10
7.3 Preparation of test samples for coating test . 11
7.3.1 Parts to be tested . 11
7.3.2 Dismantling and/or cutting and/or masking . 11
7.3.3 Determination of test area . 12
7.3.4 Preparation of electrical contact area . 13
7.4 Preparation of saline solution . 13
7.5 Procedure . 13
7.5.1 Preparation of the electro-chemical cell . 13
7.5.2 Insertion and connection of the test sample in the electro-chemical cell . 13
7.5.3 Measurement . 13
7.5.4 Calibration of the potentiostat . 14
7.6 Calculation of results . 14
7.7 Test report . 14
8 Release of nickel and its quantitative analytical detection (laboratory test) . 15
8.1 General . 15
8.2 Apparatus and consumables . 15
8.3 Preparation of test samples for laboratory test . 17
8.3.1 Parts to be tested . 17
8.3.2 Guidance on selection of test areas on the parts to be tested . 17
8.3.3 Dismantling and degreasing . 17
8.4 Procedure . 18
8.4.1 Preparation of test paper including determination of its area . 18
8.4.2 Preparation of artificial sweat solution. 19
8.4.3 Applying artificial sweat to the test paper and attaching it to the test sample . 20
8.4.4 Incubation of test sample with test paper attached (release of nickel into paper) . 20
8.4.5 Retrieval of the test paper from the test samples . 21
8.4.6 Analysis of the paper for nickel present . 21
8.5 Calculation of results . 24
8.6 Test report . 25
Annex A (normative) Selection of test areas and wrapping (Laboratory test) . 27
A.1 Rims . 27
A.2 Bridge and brace bar . 28
A.3 Sides (temples) . 29
A.4 Wrapping with sealing film . 30
Annex B (informative) Cutting and masking of test samples (EIS coating test) . 31
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B.1 Fronts . 31
B.2 Sides (temples) . 32
Bibliography . 33
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Foreword
This document (FprCEN/TS 16677:2014) 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 Formal Vote.
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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 is the revision of the method of analysis to detect the release of nickel from spectacle
frames and sunglasses (revision of EN 16128:2011, previously EN 1811:1998). The elaboration and adoption
of the present document is a first step towards, ultimately, revision of EN 16128:2011.
The availability of the new reference method for the determination of the release of nickel from spectacle
frames and sunglasses will provide the reliable framework to enforce the limit value for nickel release of
2
0,5 µg/cm /week set forth by European Regulation. It will ensure a uniform application and control of the
European legislation in all member states.
Harmonising the test method for nickel release in all member states, thereby ensuring that spectacle frames
and sunglasses placed in the market are safe, is vital with a view to protecting effectively the health and safety
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.
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1 Scope
This document specifies the reference method for the testing of spectacle frames and sunglasses for nickel
release.
The reference method supports the demonstration of conformity with the limit value for nickel release of
2
0,5 µg/cm /week set forth by European Regulation and makes provision for a uniform application and control
of the European legislation in all member states.
The reference method involves the following procedural steps (see also Clause 4):
Simulation of wear and corrosion;
EIS coating test (optional);
Laboratory test: Release of nickel and its quantitative analytical detection.
This document applies to those parts of metal spectacle frames and those metal parts of combination
spectacle frames that come into direct and prolonged contact with the skin of the wearer. This document also
applies to those relevant metal parts of articles for eye and face protection, including sunglasses.
The EIS coating test method can be applied only to metal parts which have been coated with an organic,
electrically insulating, layer.
This document does not apply to products other than spectacle frames and articles for eye and face
protection, which includes sunglasses.
NOTE The reference method for products other than spectacle frames and of articles for eye and face protection,
including sunglasses is specified in EN 1811:2011.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
EN 12472, Method for the simulation of wear and corrosion for the detection of nickel release from coated
items
EN ISO 3696:1995, Water for analytical laboratory use Specification and test methods (ISO 3696:1987)
EN ISO 11380, Optics and optical instruments Ophthalmic optics Formers (ISO 11380)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
part
that part of a sample spectacle frame or article used for eye and face protection, including
a sunglass frame, that shall be tested
Note 1 to entry: These parts are defined in 7.3.1 (for the EIS coating test) and in 8.3.1 (for the laboratory test).
3.2
component
spectacle or sunglass front, bridge or side, or component of an eye and face protector, that can be separated
from the test sample without cutting
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3.3
test paper
piece of paper used for testing, at any stage of the procedure
3.4
test sample
spectacle frame or article used for eye and face protection, including a sunglass frame, submitted for testing
Note 1 to entry: Fronts or sides may be submitted separately for testing.
3.5
extraction sample
solution obtained after extracting the test paper and making up to the required volume
3.6
appropriate tool
tool enabling the procedure to be performed without causing contamination by nickel or other metal ions,
either from the material of the tool or deposits on it
Note 1 to entry: Such tools could be made from plastics, titanium, or stainless steels with low or no nickel content.
3.7
appropriate equipment
equipment enabling to perform the procedure while avoiding contamination by nickel or other metal ions,
either from the material of the equipment or deposits on it
Note 1 to entry: For the laboratory test note that "normal" glassware could induce Nickel contamination; therefore if
using glass, use borosilicate glass, or use plastics suitable for the purpose.
4 Principle
Following the simulation of 2-years' wear according to EN 12472, the product (spectacle frame or sunglasses)
can be submitted to a coating test ("pre-test") or directly to a laboratory test.
The coating test (see Clause 7) is based on electro-impedance spectroscopy (EIS). The EIS coating test is
optional and indicative and essentially aims at demonstrating that the protective coating of the product is of
sufficient quality to prevent the release of nickel. The EIS coating test is of such nature that it can be applied
on-site by e.g. the manufacturers, importers and authorities as a part of quality control. If the result of the
EIS coating test is "pass", it may be assumed that the product is not releasing nickel at a rate greater than
2
0,5 µg/cm /week. If the EIS coating test result is "fail" or gives rise to doubt, and also for all cases where the
optional EIS coating test is not performed, the "laboratory test" for nickel ion release makes provision for
quantitative testing for the amount of nickel released, in the order of magnitude necessary to give a definitive
2
answer whether or not the frame's nickel release exceeds the limit value of 0,5 µg/cm /week.
The laboratory test (see Clause 8) is the reference method as regards the demonstration of conformity with
the requirements of European legislation. It will typically be carried out by a test laboratory and comprises two
steps: Release of nickel by artificial sweat into a test paper and the subsequent quantitative analytical
detection of the nickel released into the paper, either by solid sampling or by extraction followed by nickel
determination. The necessary detection limit is in the range of 5 ppt (for solid sampling) and in the range of
5 ppb (for extraction followed by nickel determination).
See Figure 1.
Requirements for sampling and guidance as to which parts of the frames shall be subject to testing are given
in 5.1, and in 7.3.1 (for the EIS coating test) and 8.3.1 (for the laboratory test).
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Figure 1 — Flowchart
5 Sampling and preparation of test samples
5.1 Selection of test samples
For the EIS coating test, two specimens of each spectacle frame and/or sunglass model to be tested shall be
selected at random.
For the laboratory test, two specimens of each spectacle frame and/or sunglass model to be tested shall be
selected at random.
The selected specimens shall be identified as test sample 1 and test sample 2.
Subject to the agreement by the person ordering the test, samples used for the EIS coating test ("pre-test")
can be tested in a subsequent laboratory test, but not vice versa.
If a sample is likely to be subjected to the laboratory test after the coating test, it should be washed in
deionised water immediately after the coating test and allowed to dry to avoid any corrosion by the sodium
chloride. The simulated wear and corrosion test in Clause 6 should not be repeated. It is preferable that new
samples are used for the laboratory test.
Prior to performing the EIS coating test (see Clause 7) and/or the laboratory test (see Clause 8), as
applicable, all test samples shall be prepared and conditioned as specified in 5.2, then be subjected to the
simulation of 2-years' wear as specified in EN 12472 (see Clause 6).
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5.2 Preparation and conditioning of test samples
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 -1,00 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 11380. The bevel angle of the edged lens
shall be 120° -2° +3° for spectacle frames featuring a rim with a groove.
Spectacle sides and fronts shall be separated from each other, and end covers (side tips) removed from sides
where appropriate. Unless they have a metal-bearing surface, remove nose pads before the wear phase.
Dismantling of sides from fronts may be done either by unscrewing the joint screw or by cutting the joint
across the charniers.
WARNING: Care shall be taken not to damage the coating on the frame on areas that are subsequently
tested, particularly the coating near the cut.
Ensure that all the separate components of the test samples remain identified throughout all steps of the
overall procedure.
6 Simulation of 2-years' wear
Prior to submission to the selected test, the test samples shall be subject to the method for simulation of
2-years' wear according to EN 12472.
Fix fronts and sides separately onto the retaining system and slide into the rotating barrel.
When the accelerated wear process is completed, remove the test samples. Gently swirl the sample(s) for
2 min in degreasing solution at room temperature. Rinse thoroughly with de-ionised water and gently dry in an
air stream. After degreasing, handle the samples with appropriate tools or clean protective gloves.
Remove lenses from fronts by unscrewing the closing block joint.
NOTE Pushing dummy lenses out is very likely to damage the coating.
Disassemble three-piece rimless fronts. Disassemble fronts of combination frames and remove any plastics
parts.
Then subject the test samples' components to the selected test: EIS coating test, see Clause 7, and/or
laboratory test, see Clause 8.
7 EIS method (coating test)
7.1 General
The purpose of the EIS test is to verify if the surface treatment of a metal spectacle frame or sunglass is able
to limit the release of metal ions (hence including nickel), in order to identify good coatings that definitely pass
from those whose results are borderline or fail. Test samples which are not identified as good shall be
subjected to the laboratory test. If the coating test gives a pass result, there is no need to do a laboratory test.
The parts of spectacle frames needing consideration are only those likely to come into direct and prolonged
contact with the skin of the wearer, that is, the sides (temples), bridge and rims. See 7.3.1.
This method can only be applied to test samples with organic coatings but not with conductive coatings such
as metal plating, rolled gold and/or for test samples made from uncoated metal.
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7.2 Apparatus and consumables
Except where indicated, all reagents, containers, measuring cylinders, etc., shall be demonstrably free of nickel
ions.
7.2.1 Masking agent, suitable for electroplating purposes and capable of electrically insulating the test
sample from the saline solution. Application of more than one coat is acceptable, and may be preferable.
Test the masking agent to verify that it is suitable by using it to coat a metal rod without an organic coating
and show that the adhesion is good and impedance results are high(greater than 1,0E+07).
It is recommended that the masking agent be coloured or fluorescent, to make the masked areas more visible.
1)
NOTE Lacomit is the trade name of a suitable product.
7.2.2 Deionised water, according to EN ISO 3696:1995, grade 3 or Ph.Eur., for rinsing and preparation of
the saline solution (7.4).
7.2.3 Sodium chloride of recognised pro analysis, p.a., grade or better, for preparation of the saline
solution (7.4);
7.2.4 Degreasing solution, Sodium Dodecyl Sulphate (SDS) at a concentration of 2 % in deionised 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 deionised water.
7.2.6 Electro-chemical cell, made of glass, suitable for mounting firstly a Standard Calomel (SCE) or
Ag/AgCl Reference Electrode, secondly a Graphite or Platinum Counter Electrode and thirdly, the component
to be tested
NOTE 1 The recommended volume for testing sides is 500 ml, for fronts is 1000 ml. This is to enable the sample to
rest on the bottom of the cell.
NOTE 2 The recommended counter electrode is a high density pure graphite rod, approximately 6 mm in diameter.
7.2.7 Laboratory clamps, suitable for holding the (cut) test sample, as required to immerse the selected
area in electrolyte in the electro-chemical cell, but keeping the electrical contact area dry.
7.2.8 Potentiostat (en US: ohmmeter), having the ability to perform A.C. Electrochemical Impedance
Spectroscopy (EIS) at 1 Hz and having a current sensitivity of better than 1 pA.
2)
NOTE An example of suitable apparatus is Gamry apparatus series 600 with EIS 300 software package.
7.2.9 Electrical clamps, e.g. small crocodile clips, capable of providing secure electrical contact with the
test sample, reference and counter electrodes.
7.2.10 Calibration (dummy) cell, appropriate to test the potentiostat in the impedance range expected.
7.2.11 Appropriate tools, needed to perform the procedure. See 3.6 for the definition of "appropriate" tools.
To prevent possible contamination by nickel or other metal ions, clean all tools well before use.
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.
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7.2.12 Laboratory gloves, e.g. latex, not cotton.
7.3 Preparation of test samples for coating test
7.3.1 Parts to be tested
Two spectacle frames or articles for eye and face protection, including sunglass frames, (the test samples)
shall be tested. See 5.1 for sampling requirements.
For EIS testing of spectacle or sunglass frames, the parts to be tested are:
a) the spectacle front, comprising the rims including the groove, the bridge and the brace bar (if applicable)
but excluding the pad arms and pad boxes, lugs and closing block joints;
b) sides (temples), including metal collets, but excluding the joints and the zone immediately around the
joints, and parts intended to be protected by plastic end covers (tips).
For each of the two test samples, the front and the two sides shall be tested separately; all three components
shall pass in order for the frame to pass.
7.3.2 Dismantling and/or cutting and/or masking
7.3.2.1 General
Prior to submission to the EIS test, the test sample shall have been subject to the method for simulation of
2-years' wear according to EN 12472. See Clause 6.
Select and separate those parts (or areas) which are subject to testing from those that are not. This can be
achieved by one or more of the following:
a) dismantling (see 7.3.2.2);
b) cutting (see 5.2, 7.3.2.3 and Annex B);
c) masking (see 7.3.2.4 and Annex B).
Consider the need for preparing the electrical contact area (see 7.3.4) and for determination of surface area
(see 7.3.3) when deciding where to cut or which areas to mask. Masking any "complicated" details of the test
sample which would not come into contact with the skin could simplify the determination of surface area
and/or enhance its precision.
Cutting of the test samples, to separate the parts (or areas) to be tested from those not to be tested, is
permissible, but should be avoided if at all possible.
NOTE Cutting can be avoided by masking all of the frame except those parts to be subjected to the test.
CAUTION — If cutting is undertaken, great care shall be taken to avoid contamination of metal ions
e.g.
from the base material;
from metal particles getting underneath the masking;
by damaging the organic coating that is near the cut and subsequently tested;
metal on tools or fingers or workplace.
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Ensure that all the separate parts of the test samples remain identified, e.g. test serial number, while not
physically touching or modifying them.
7.3.2.2 Dismantling
If not already removed for the wear test, dismantle nose pads from fronts.
7.3.2.3 Cutting
Cut the frame by hand-sawing or cutting pliers.
Cut edges other those intended for use as electrical contact areas (see 7.3.4) and any other areas of the parts
to be tested that are not covered by organic coating will require masking. See 7.3.2.4 for requirements
regarding masking.
Be careful to round-off cut edges in order to help get a good even coating of masking agent.
7.3.2.4 Masking
Gently swirl the test sample(s) for 2 min in degreasing solution (7.2.4) at room temperature. Rinse th
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