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 and sunglasses 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 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.
Augenoptik - Referenzverfahren für die 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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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
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.
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
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.
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
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 unda
...
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