EN 16128-2011 5000 Reference test method for release of nickel from those parts of spectacle frames and sunglasses intended to come into close and prolonged contact with the skin《与.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 16128:2011Reference test method forrelease of nickel from thoseparts of spectacle frames andsunglasses intended to comeinto close and prolongedcontact with the skinCopyrigh

2、t European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 16128:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 16128:2011. Together with BS EN 181

3、1:2011, it supersedes BS EN 1811:1998+A1:2008, which will be withdrawn on 1 March 2013.NOTE: BSI, as the UK member body of CEN, has adopted EN 1811:2011 as a British Standard. However, the content of EN 1811:2011 was voted against by UK committee STI/53, Specifications and test methods for jewellery

4、 and horology, during its development.The UK participation in its preparation was entrusted to Technical Committee CH/172/3, Spectacles.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary pro

5、visions of a contract. Users are responsible for its correct application. BSI 2011 ISBN 978 0 580 71506 8 ICS 11.040.70 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Commit

6、tee on 30 April 2011.Amendments issued since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 16128:2011EUROPEAN STANDARD NORME EUROPENNE EUROPI

7、SCHE NORM EN 16128 March 2011 ICS 11.040.70 Supersedes EN 1811:1998+A1:2008English Version Reference test method for release of nickel from those parts of spectacle frames and sunglasses intended to come into close and prolonged contact with the skin Mthode dessai de rfrence relative la libration du

8、 nickel par les parties des montures de lunettes et lunettes de soleil destines entrer en contact direct et prolong avec la peau Referenzprfverfahren zur Bestimmung der Nickellssigkeit derjenigen Teile von Brillenfassungen und Sonnenbrillen, die bestimmungsgem unmittelbar und lnger mit der Haut in B

9、erhrung kommen This European Standard was approved by CEN on 9 January 2011. 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-date lists and bibli

10、ographical 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 under the respons

11、ibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Gree

12、ce, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Manageme

13、nt Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16128:2011: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or

14、networking permitted without license from IHS-,-,-BS EN 16128:2011EN 16128:2011 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Principle 53 Reagents .54 Apparatus .65 Samples 75.1 Sample area 75.1.1 Definition of sample area 75.1.2 Determination of sample area 75.1.3 Areas other than sample

15、 areas 75.2 Sample preparation .75.3 Reference disc .76 Procedure .86.1 Preparation of test solution 86.2 Release procedure .86.3 Determination of nickel .86.4 Number of replicates .86.5 Blank tests 97 Calculations 97.1 Nickel release .97.2 Interpretation of results 98 Test report 9Annex A (informat

16、ive) Statistical uncertainty of the test procedure and interpretation of results . 11Annex B (informative) Rules for production and preparation of reference material . 13Annex C (informative) Identification and determination of sample area; and coating of non-significant areas 15C.1 Identification a

17、nd determination of sample area . 15C.2 Coating of non-significant areas . 15Annex D (informative) Articles made from materials that can release small amounts of nickel . 16Bibliography . 17Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reprod

18、uction or networking permitted without license from IHS-,-,-BS EN 16128:2011EN 16128:2011 (E) 3 Foreword This document (EN 16128:2011) 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

19、 a national standard, either by publication of an identical text or by endorsement, at the latest by September 2011, and conflicting national standards shall be withdrawn at the latest by September 2011. Attention is drawn to the possibility that some of the elements of this document may be the subj

20、ect of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document, together with EN 1811:2011, supersedes EN 1811:1998+A1:2008. This document has been prepared under a mandate given to CEN by the European Commission and the European F

21、ree Trade Association. This document supports essential requirements of Commission Regulation (EC) No 1907/2006 (REACH) of the European Parliament and the Council. List of the significant technical changes that have been made in this new version of EN 1811 in comparison with the former edition EN 18

22、11:1998+A1:2008: The scope of the former European Standard was divided: EN 1811:2011 is applicable for all products but spectacle frames and sunglasses; EN 16128:2011 is applicable for spectacle frames and sunglasses; List of the significant technical changes of EN 1811:2011 as compared to the forme

23、r European Standard: The scope was expanded to include all post assemblies which are inserted into pierced parts of the human body; The preparation of the test solution was tested and changed; The correction factor was eliminated and the concept of measurement uncertainty introduced; The Standard co

24、ntains a new normative Annex C on the preparation of articles prior to nickel testing; EN 16128:2011 is technically unchanged as compared to the former European Standard EN 1811:1998+A1:2008. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following cou

25、ntries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slo

26、venia, Spain, Sweden, Switzerland and the United Kingdom. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 16128:2011EN 16128:2011 (E) 4 Introduction Adverse skin reaction t

27、o nickel has been known for many decades. Nickel is now the most frequent cause of contact allergy in Europe, and 10 % to 20 % of the female population is allergic to nickel. Skin absorption of nickel ions, which are released from some nickel-containing materials in direct and prolonged contact with

28、 the skin, causes sensitisation. Further exposure to soluble nickel salts results in allergic contact dermatitis. It is known that sensitisation to nickel requires higher exposure levels than does the elicitation in already sensitised individuals. There is a large variation in the degree of sensitiv

29、ity to nickel between individuals. This widespread health problem has forced the urgent introduction of a number of measures designed to reduce its prevalence. They include this standard which attempts to provide an in-vitro chemical test that correlates as far as possible with the variable human bi

30、ological reactions that occur when metallic articles containing nickel are in direct and prolonged contact with the skin. The standard provides a measure of the amount of nickel release from an article immersed for one week in artificial sweat. It is a first attempt at the standardisation of a test

31、method that previously has been used in research, and it is expected to require early revision in the light of further experience. The standard also describes the preparation of a reference material intended to assist a laboratory in achieving an acceptable precision. Clinical patch-testing of a sma

32、ll selection of nickel-containing alloys and coatings on nickel-sensitized persons indicates that high and low results achieved with the present analytical method correspond closely with patch-test reactivity. Moreover, a nickel release rate threshold of 0,5 g/cm2/week has been set in European Parli

33、ament and Council Directive 94/27/EC (OJ No. L188 of 22.7.94). In order to ensure that articles yielding values near this figure are not unnecessarily excluded from European trade as a result of the difficulties inherent in the test method, particularly when applied to intricately-shaped articles, t

34、he measured release figures are multiplied by a factor of 0,1. Materials recognized as causing sensitisation to nickel would not become acceptable by use of this adjustment. Application of this standard is confidently expected to reduce significantly the development of allergic contact dermatitis du

35、e to nickel. Experience of its use and further epidemiological and clinical research may justify changes to test procedure and/or interpretation of the test result. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking perm

36、itted without license from IHS-,-,-BS EN 16128:2011EN 16128:2011 (E) 5 1 Scope This European Standard specifies a method for simulating the release of nickel from those parts of spectacle frames and sunglasses intended to come into direct and prolonged contact with the skin in order to determine whe

37、ther they release nickel at a rate greater than 0,5 g/cm2/week. NOTE 1 This European Standard, EN 16128, has been prepared in reply to the European Commissions Mandate M/448 addressed to CEN. From the technical point of view, this European Standard provides an unchanged re-publication of the technic

38、al requirements that had previously been specified in EN 1811:1998, but restricted in scope to apply only to spectacle frames and sunglasses. NOTE 2 Users of this European Standard may wish to note that, also in reply to the European Commissions Mandate M/448, this European Standard is currently sub

39、ject to review with the objective of developing a new standardized method to supersede this European Standard when the new method becomes available. NOTE 3 Nickel release testing of products other than spectacle frames and sunglasses is specified in EN 1811:2011. 2 Principle The parts to be tested f

40、or nickel release are placed in an artificial sweat test solution for 1 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 nickel release is expressed in micr

41、ograms per square centimetre per week (g/cm2/week). 3 Reagents Except where indicated, all reagents shall be of recognized pro analysis, p.a., grade or better and shall be free of nickel. 3.1 Deionized and aerated water. Fill a tall-form 2-l beaker with deionized water, specific conductivity max. 1

42、S/cm. Saturate with air by attaching a gas distribution tube (porosity 1) to a cork and positioning the lower end of the tube on the bottom of the beaker. Allow grease-free air to flow at a rate of 150 ml/min. for 30 min. 3.2 Sodium chloride. 3.3 DL-Lactic acid, = 1,21 g/ml, 88 % (m/m). 3.4 Urea. 3.

43、5 Ammonia solution, = 0,91 g/ml, 25 % (m/m). 3.6 Dilute ammonia solution, 1 % (m/m). Transfer 10 ml of ammonia solution (3.5) into a 250-ml beaker containing 100 ml of deionized water. Stir and cool to room temperature. Transfer the solution to a 250-ml volumetric flask and make up to volume with de

44、ionized water. 3.7 Nitric acid, = 1,40 g/ml, 65 % (m/m). 3.8 Dilute nitric acid, approximately 5 % (m/m). Transfer 30 ml of nitric acid (3.7) into a 500-ml beaker containing 350 ml of deionized water. Stir and cool to room temperature. Transfer the solution to a 500-ml volumetric flask and make up t

45、o volume with deionized water. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 16128:2011EN 16128:2011 (E) 6 3.9 Degreasing solution. Dissolve 5 g of an anionic surface-act

46、ive agent such as sodium dodecylbenzene sulfonate or sodium alkylaryl sulfonate in 1 000 ml water. An appropriately-diluted, neutral, commercially-available detergent may be used. 3.10 Wax or lacquer (suitable for electroplating purposes) capable of protecting a surface from nickel release. The wax

47、or lacquer shall be shown to prevent nickel release from a nickel-releasing surface when one or more coats of the wax or lacquer are applied in the same manner as on a test sample, and tested for nickel release according to Clause 6 (see Annex C). 4 Apparatus 4.1 A pH-meter, accurate to 0,02 pH. 4.2

48、 An analytical spectrometer capable of detecting a concentration of 0,01 mg nickel per litre. The instrument shall, after optimization, meet the performance criteria given in 4.2.1 and 4.2.2. It is recommended that either an inductively-coupled plasma optical emission spectrometer or an electrothermal excitation atomic absorption spectrometer is used. 4.2.1 Minimum precision. The standard deviation of 10 measurements of the absorption of a full matrix calibration solution containing 0,05 mg nickel per litre shall not excee