1、February 2016 English price group 17No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.70!%LE“2413456www.din.de
2、DIN EN 16128Ophthalmic optics Reference method for the testing of spectacle frames and sunglasses for nickel release;English version EN 16128:2015,English translation of DIN EN 16128:2016-02Augenoptik Referenzverfahren fr die Bestimmung der Nickellssigkeit von Brillenfassungen und Sonnenbrillen;Engl
3、ische Fassung EN 16128:2015,Englische bersetzung von DIN EN 16128:2016-02Optique ophtalmique Mthode dessai de rfrence relative la libration du nickel par les montures de lunettes et les lunettes de soleil;Version anglaise EN 16128:2015,Traduction anglaise de DIN EN 16128:2016-02Supersedes DIN EN 161
4、28:2011-05;supersedes DIN CEN/TS 16677 (DIN SPEC 13450):2014-07See start of applicationSupersedes: see belowwww.beuth.deDocument comprises 3 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.901.16DIN EN 16128:2016-02 2 A comma i
5、s used as the decimal marker. Start of application The start of application of this standard is 2016-02-01. As stated in the European foreword, CEN members are to withdraw national standards that conflict with this document by November 2018. It should be noted, however, that this does not imply that
6、 the use of the new reference method described in the present document is not binding until November 2018. Use of this method becomes binding once EN 16128:2015 is cited in the Official Journal of the European Union, taking any transition periods into consideration. At the time the German version of
7、 DIN EN 16128 went into production, this citation in the Official Journal of the EU had not yet taken place. Users of this standard should carefully monitor the status of EN 16128 and/or its citation in the Official Journal of the EU. National foreword This document (EN 16128:2015) has been prepared
8、 by Technical Committee CEN/TC 170 “Ophthalmic optics” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-01-08-08 AK Brillenfassungen.
9、This standard has been prepared under a mandate given to CEN by the European Commission in connection with the European REACH regulation and for the purposes of revising the reference method for testing spectacle frames and sunglasses for nickel release. Following the publication of Technical Specif
10、ication DIN CEN/TS 16677 (DIN SPEC 13450) in July 2014, the present standard is a further step in replacing the harmonized standard EN 16128:2011 that had been cited in the Official Journal of the EU. With the publication of this document, all those involved in the testing of the nickel release of s
11、pectacle frames and sunglasses now can switch over to the new reference method. In Germany, use of the symbol “dpt” for dioptre (expressed in m-1) is legally required and this symbol is to be used rather than the symbol D used in other countries. Amendments This standard differs from DIN EN 16128:20
12、11-05 and DIN CEN/TS 16677 (DIN SPEC 13450):2014-07 as follows: a) the reference test method has been substantially revised: In the method according to EN 16128:2011 the parts to be tested for nickel release are placed in an artificial sweat test solution for one week. The concentration of dissolved
13、 nickel in the solution is determined by atomic absorption spectrometry, inductively-coupled plasma spectrometry or other appropriate analytical method. DIN EN 16128:2016-02 3 The present standard provides, for parts with an organic coating, a coating test based on Electrochemical Impedance Spectros
14、copy (EIS). The coating test aims at demonstrating that the coating is of sufficient quality to prevent the release of nickel, thereby ensuring that the test samples nickel release does not exceed the regulatory limit. For parts without an organic coating, the present standard specifies a migration
15、test. The migration test makes provision for quantitative testing for the amount of nickel released, to determine whether or not the models nickel release exceeds the regulatory limit. The migration test comprises two steps: Release of nickel by artificial sweat solution into a test paper and the su
16、bsequent quantitative analytical detection of the nickel released into the paper. See also the principle described in Clause 4. b) Compared to CEN/TS 16677:2014 the revisions and refinements made are relatively minor, as follows: For the coating test, see Clause 7: amendment of the calculation and p
17、resentation of the test result including amendment of the threshold value (see 7.6); the dummy or test lenses used in the simulation of wear and corrosion are to be kept in the frame. For the migration test, see Clause 8: inclusion of the requirement to prepare and analyze a blank sample with every
18、batch of test samples, along with the relevant specifications of sample preparation and procedure (see 8.4.4); specification that the incubation shall be made using a climate chamber; the previously permissible alternative to use an oven with a container for insertion of the test samples has been de
19、leted (see 8.4.5); inclusion of more detailed specifications as to the permissible and non-permissible combination of the test papers from the various test areas for the analysis; inclusion of directions on how to proceed in the case that the design of a model does not allow the application of the t
20、est paper at (one of) the specified location(s); amendment of the procedure for the application and sealing of the test paper onto the test area using the sealing film; as an alternative to wrapping with the sealing film it is now also permissible to use a folding technique; see the revised Annex B;
21、 recommendation that the time between the retrieval of the test papers from the test samples and their extraction and analysis does not exceed three days (see 8.4.6). c) the text of EN 16128:2015 has been adopted in its entirety. Previous editions DIN EN 1811: 1999-01, 2008-06 DIN EN 1811 Corrigendu
22、m 1: 2008-09 DIN EN 16128: 2011-05 DIN CEN/TS 16677 (DIN SPEC 13450): 2014-07 DIN EN 16128:2016-02 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16128 November 2015 ICS 11.040.70 Supersedes CEN/TS 16677:2014, EN 16128:2011English Version Ophthalmic optics -
23、Reference method for the testing of spectacle frames and sunglasses for nickel release Optique ophtalmique - Mthode dessai de rfrence relative la libration du nickel par les montures de lunettes et les lunettes de soleil Augenoptik - Referenzverfahren fr die Bestimmung der Nickellssigkeit von Brille
24、nfassungen und Sonnenbrillen This European Standard was approved by CEN on 19 September 2015. 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-dat
25、e 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
26、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, Form
27、er 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 COMIT
28、EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16128:2015 EEN 16128:2015 (E) 2 Contents Page European fo
29、reword . 4 Introduction 6 1 Scope 7 2 Normative references 7 3 Terms and definitions . 7 4 Principle . 8 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 10 7.3 P
30、reparation of test samples for the 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 13 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 el
31、ectro-chemical cell . 13 7.5.2 Insertion and connection of the test part in the electro-chemical cell . 14 7.5.3 Determination of open circuit potential and measurement of electrochemical impedance of test samples 14 7.5.4 Calibration and verification of the equipment 15 7.6 Calculation of results 1
32、5 7.6.1 General . 15 7.6.2 Criteria for pass or fail of the test sample . 15 7.7 Test report 15 8 Release of nickel and its quantitative analytical detection (migration test) . 16 8.1 General . 16 8.2 Apparatus and consumables 16 8.3 Preparation of test samples for the migration test 18 8.3.1 Parts
33、to be tested 18 8.3.2 Guidance on selection of test areas on the parts to be tested 18 8.3.3 Dismantling and degreasing 19 8.4 Procedure 19 8.4.1 Preparation of test paper including determination of its area . 19 8.4.2 Preparation of artificial sweat solution . 20 8.4.3 Applying artificial sweat sol
34、ution to the test paper and attaching it to the test sample 21 8.4.4 Blank sample . 22 8.4.5 Incubation of test sample with test paper attached (release of nickel into paper) . 22 8.4.6 Retrieval of the test paper from the test samples 22 DIN EN 16128:2016-02 EN 16128:2015 (E) 3 8.4.7 Analysis of th
35、e test papers for nickel 22 8.5 Calculation of migration test results . 24 8.6 Interpretation of migration test results . 25 8.6.1 General . 25 8.6.2 Assessment of 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
36、 (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 DIN EN 16128:2016-02 EN 16128:2015 (E) 4 European foreword This document (EN 1
37、6128:2015) 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 May 2016, and conflicti
38、ng national standards shall be withdrawn at the latest by November 2018. 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. This document
39、 supersedes EN 16128:2011 and CEN/TS 16677:2014. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports the harmonising effect of a restriction adopted under Regulation (EC) No 1907/2006 (REACH) of the European Pa
40、rliament and the Council. Compared to EN 16128:2011 and CEN/TS 16677:2014, the following changes have been made: a) Compared to EN 16128:2011, the reference test method has been substantially revised: In the method according to EN 16128:2011 the parts to be tested for nickel release are placed in an
41、 artificial sweat test solution for one week. The concentration of dissolved nickel in the solution is determined by atomic absorption spectrometry, inductively-coupled plasma spectrometry or other appropriate analytical method. The present standard provides, for parts with an organic coating, a coa
42、ting test based on Electrochemical Impedance Spectroscopy (EIS). The coating test aims at demonstrating that the coating is of sufficient quality to prevent the release of nickel, thereby ensuring that the test samples nickel release does not exceed the regulatory limit. For parts without an organic
43、 coating, the present standard specifies a migration test. The migration test makes provision for quantitative testing for the amount of nickel released, to determine whether or not the models nickel release exceeds the regulatory limit. The migration test comprises two steps: Release of nickel by a
44、rtificial sweat solution into a test paper and the subsequent quantitative analytical detection of the nickel released into the paper. See also the principle described in Clause 4. b) Compared to CEN/TS 16677:2014 the revisions and refinements made are relatively minor, as follows: For the coating t
45、est, see Clause 7: Amendment of the calculation and presentation of the test result including amendment of the threshold value (see 7.6); The dummy or test lenses used in the simulation of wear and corrosion are to be kept in the frame. For the migration test, see Clause 8: DIN EN 16128:2016-02 EN 1
46、6128:2015 (E) 5 Inclusion of the requirement to prepare and analyze a blank sample with every batch of test samples, along with the relevant specifications of sample preparation and procedure (see 8.4.4); Specification that the incubation shall be made using a climate chamber; the previously permiss
47、ible alternative to use an oven with a container for insertion of the test samples has been deleted (see 8.4.5); Inclusion of more detailed specifications as to the permissible and non-permissible combination of the test papers from the various test areas for the analysis; Inclusion of directions on
48、 how to proceed in the case that the design of a model does not allow the application of the test paper at (one of) the specified location(s); Amendment of the procedure for the application and sealing of the test paper onto the test area using the sealing film; as an alternative to wrapping with th
49、e sealing film it is now also permissible to use a folding technique; see the revised Annex B; Recommendation that the time between the retrieval of the test papers from the test samples and their extraction and analysis does not exceed 3 d (see 8.4.6). According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germa
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