BS EN 16128-2011 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.pdf
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1、- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - w - - - - - - - - - - EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16128 March 2011 ICS 11.040.70 Supersedes EN 1811:1998+A1:2008 English Version Reference test method for release of nickel
2、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 nickel par les parties des montures de lunettes et lunettes de soleil destines entrer en contact direct et prolong avec la peau Refere
3、nzprfverfahren zur Bestimmung der Nickellssigkeit derjenigen Teile von Brillenfassungen und Sonnenbrillen, die bestimmungsgem unmittelbar und lnger mit der Haut in Berhrung kommen This European Standard was approved by CEN on 9 January 2011. CEN members are bound to comply with the CEN/CENELEC Inter
4、nal Regulations which stipulate the conditions for giving this European Standard the status of a national standard 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
5、CEN member. This European Standard exists in three official versions (English, French, German). A version in 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 ver
6、sions. CEN members are the national standards bodies of 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, S
7、lovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CE
8、N national Members. Ref. No. EN 16128:2011: E EN 16128:2011 (E) 2 Contents Page Foreword 3 Introduction .4 1Scope 5 2Principle 5 3Reagents .5 4Apparatus .6 5Samples 7 5.1Sample area 7 5.1.1Definition of sample area 7 5.1.2Determination of sample area 7 5.1.3Areas other than sample areas 7 5.2Sample
9、preparation .7 5.3Reference disc .7 6Procedure .8 6.1Preparation of test solution 8 6.2Release procedure .8 6.3Determination of nickel .8 6.4Number of replicates .8 6.5Blank tests 9 7Calculations 9 7.1Nickel release .9 7.2Interpretation of results 9 8Test report 9 Annex A (informative) Statistical u
10、ncertainty of the test procedure and interpretation of results . 11 Annex B (informative) Rules for production and preparation of reference material . 13 Annex C (informative) Identification and determination of sample area; and coating of non- significant areas 15 C.1Identification and determinatio
11、n of sample area . 15 C.2Coating of non-significant areas . 15 Annex D (informative) Articles made from materials that can release small amounts of nickel . 16 Bibliography . 17 EN 16128:2011 (E) 3 Foreword This document (EN 16128:2011) has been prepared by Technical Committee CEN/TC 170 “Ophthalmic
12、 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 September 2011, and conflicting national standards shall be withdrawn at the latest by September
13、2011. 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, together with EN 1811:2011, supersedes EN 1811:1998+A1:2008. This
14、 document has been prepared under a mandate given to CEN by the European Commission and the European Free 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
15、changes that have been made in this new version of EN 1811 in comparison with the former edition EN 1811:1998+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 fra
16、mes and sunglasses; List of the significant technical changes of EN 1811:2011 as compared to the former 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 c
17、orrection factor was eliminated and the concept of measurement uncertainty introduced; The Standard contains 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. Accord
18、ing 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, France, Germany, Greece, Hungary, Iceland, Ireland, Ital
19、y, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. EN 16128:2011 (E) 4 Introduction Adverse skin reaction to nickel has been known for many decades. Nickel is now the most frequent cause of c
20、ontact 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 the skin, causes sensitisation. Further exposure to soluble nickel salts results in
21、 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 sensitivity to nickel between individuals. This widespread health problem has forced the urg
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