1、BSI Standards PublicationBS EN 16128:2015Ophthalmic optics Referencemethod for the testingof spectacle frames andsunglasses for nickel releaseBS EN 16128:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 16128:2015. It supersedes BS EN 16128:2011 and PD CEN/T
2、S 16677:2014 which are withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/172, Ophthalmic optics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovis
3、ions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 86487 2ICS 11.040.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published u
4、nder the authority of theStandards Policy and Strategy Committee on 30 November 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 16128:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16128 November 2015 ICS 11.040.70 Supersedes CEN/TS 16677:2014, EN 16128
5、:2011English Version Ophthalmic optics - 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
6、Bestimmung der Nickellssigkeit von Brillenfassungen 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 s
7、tandard 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 i
8、n 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
9、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. EURO
10、PEAN COMMITTEE FOR STANDARDIZATION COMIT 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 EBS E
11、N 16128:2015EN 16128:2015 (E) 2 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 8 6 Simulation of wear and corrosion . 9 6.1 Preparation of test samples 9 6.2 Procedure 10 7 Coating test . 1
12、0 7.1 General . 10 7.2 Apparatus and consumables 10 7.3 Preparation 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 s
13、olution . 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 . 14 7.5.3 Determination of open circuit potential and measurement of electrochemical impedance of test samples 14 7.5.4 Calibration and veri
14、fication of the equipment 15 7.6 Calculation of results 15 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 Preparati
15、on of test samples for the migration test 18 8.3.1 Parts 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 artificia
16、l sweat solution . 20 8.4.3 Applying artificial sweat solution 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 BS E
17、N 16128:2015EN 16128:2015 (E) 3 8.4.7 Analysis of the 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
18、 samples (Coating test) . 27 A.1 Fronts 27 A.2 Sides (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 BS EN 16128:2015EN 16128:2
19、015 (E) 4 European foreword This document (EN 16128:2015) 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 endors
20、ement, at the latest by May 2016, and conflicting 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 identifyi
21、ng any or all such patent rights. This document 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 Regulati
22、on (EC) No 1907/2006 (REACH) of the European Parliament 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 t
23、o be tested for nickel release are placed in an 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 pro
24、vides, for parts with an organic coating, a coating 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
25、 regulatory limit. For parts without an organic 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 t
26、est comprises two steps: Release of nickel by artificial 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
27、relatively minor, as follows: For the coating test, 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 migratio
28、n test, see Clause 8: BS EN 16128:2015EN 16128:2015 (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
29、 a climate chamber; the previously permissible 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 fo
30、r 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 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 f
31、ilm; as an alternative to wrapping with the 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). Acco
32、rding 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, Germany
33、, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 16128:2015EN 16128:2015 (E) 6 Introduction This document has been prepared under Mand
34、ate 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
35、 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 frame
36、s 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 of 0,5 g/cm2/week set forth by European Regulation. It will ensure a uniform application and control of the
37、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 signi
38、ficant health issue. BS EN 16128:2015EN 16128:2015 (E) 7 1 Scope This European Standard 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 demonstra
39、tion of conformity with the limit value for nickel release of 0,5 g/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 combi
40、nation 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
41、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 refer
42、ences, 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, Water for analytical laborator
43、y use Specification and test methods (ISO 3696) 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 model spectacle frame, ready-to-wear spectacles, sunglass or ot
44、her item used for eye and face protection produced to a common design, using the same materials and surface treatment, and to which the scope of this document applies 3.2 test sample spectacle frame, ready-to-wear spectacles, sunglass or other item used for eye and face protection submitted for test
45、ing Note 1 to entry: Fronts or sides may be submitted separately for testing. 3.3 test part part of a test sample that is intended to come into direct and prolonged contact with the skin and is due to be tested Note 1 to entry: These parts are defined in 7.3.1 (for the coating test) and in 8.3.1 (fo
46、r the migration test). BS EN 16128:2015EN 16128:2015 (E) 8 3.4 test paper piece of laboratory cellulose paper used for testing, at any stage of the procedure after being cut to size for testing 3.5 extraction solution solution obtained after extraction of nickel ions from the test paper 3.6 appropri
47、ate 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 enablin
48、g 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 according to the method specified in EN 12472 (see Clause 6), the reference method compr
49、ises 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 samples nickel release does not exceed the regulatory limit. The coating test is, however, not sensitive only to nickel ions, so a model can pass the migration test even though it failed the coating test. 2) Migr
