BS EN 1811-2011 Reference test method for release of nickel from all post assemblies which are inserted into pierced parts of the human body and articles intended to come into dire.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 1811:2011Reference test method forrelease of nickel from allpost assemblies which areinserted into pierced parts ofthe human body and articlesintended to come into directan

2、d prolonged contact withthe skinLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/11/2011 07:29, Uncontrolled Copy, (c) BSIBS EN 1811:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 1811:2011. Together with BS EN 16128:2011, it supersedes BS EN 1811

3、:1998+A1:2008, which will be withdrawn on 1 March 2013.As the UK member of CEN, BSI is obliged to publish EN 1811:2011 as a British Standard. However, attention is drawn to the fact that the UK committee voted against its approval as a European Standard for the following reasons:1. The UK committee

4、supports the need to replace the existing 0,1 correction factor in the 1998 edition. However, the validation process based on ISO 5725 that was used to arrive at the uncertainty of measurement resulted in an estimate for the combined measurement uncertainty of 46%. This value does not take into acco

5、unt all of those aspects of the method which can influence the uncertainty of measurement.2. Two of the four possible results categories (see informative Annex A), give no clear indication of whether an article is compliant with Council Regulation (EC) No 1907/2006 of the European Parliament. The UK

6、 committee is of the opinion that this degree of uncertainty over interpretation of results is impractical and that to avoid this, clear pass/fail criteria are required to ensure clarity of test results.The UK participation in its preparation was entrusted to Technical Committee STI/53, Specificatio

7、ns and test methods for jewellery and horology.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 provisions of a contract. Users are responsible for its correct application. BSI 2011ISBN 97

8、8 0 580 63711 7ICS 39.060Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2011.Amendments issued since publicationDate Text affectedLicensed Copy: Wang

9、Bin, ISO/EXCHANGE CHINA STANDARDS, 14/11/2011 07:29, Uncontrolled Copy, (c) BSIBS EN 1811:2011EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1811 March 2011 ICS 39.060 Supersedes EN 1811:1998+A1:2008English Version Reference test method for release of nickel from all post assemblies which are

10、inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin Mthode dessai de rfrence relative la libration du nickel par les assemblages de tiges qui sont introduites dans les parties perces du corps humain et les produits destins entre

11、r en contact direct et prolong avec la peauReferenzprfverfahren zur Bestimmung der Nickellssigkeit von smtlichen Stben, die in durchstochene Krperteile eingefhrt werden und Erzeugnissen, die unmittelbar und lnger mit der Haut in Berhrung kommen This European Standard was approved by CEN on 5 Februar

12、y 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 bibliographical references concerning such national standards may be obtai

13、ned 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 responsibility of a CEN member into its own language and notified to the CEN

14、-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, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg,

15、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 Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of e

16、xploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1811:2011: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/11/2011 07:29, Uncontrolled Copy, (c) BSIBS EN 1811:2011EN 1811:2011 (E) 2 Contents Page Foreword 4Introduction .51 Scope 62 Normati

17、ve references 63 Terms and definitions .64 Principle of the procedure 75 Reagents .76 Apparatus .87 Samples 97.1 Sample area 97.1.1 Definition of sample area 97.1.2 Determination of sample area 97.1.3 Masking of areas other than sample area .97.2 Sample degreasing before testing .97.3 Quality contro

18、l samples 98 Procedure 108.1 Preparation of test solution . 108.2 Release procedure 108.3 Determination of nickel 118.3.1 General . 118.3.2 Calibration solutions 118.3.3 Detection limit and quantification limit 118.3.4 Number of test samples . 118.3.5 Number of replicate measurements 118.4 Blank tes

19、ts . 119 Calculations . 119.1 Nickel release 119.2 Interpretation of results . 129.2.1 General . 129.2.2 Assessment of non-compliance 129.2.3 Uncertainty budget . 1310 Test report . 13Annex A (informative) Expanded measurement uncertainty of the test procedure and compliance assessment . 14Annex B (

20、normative) Requirements for quality control material 16Annex C (normative) Requirements for preparation of all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin prior to nickel testing 18C.1 General .

21、 18C.2 Requirements and principle 18C.3 Determination of the nickel release test method . 18C.4 Determination of surfaces coming into direct and prolonged contact with the skin or pierced parts of the body . 18C.4.1 Procedures for homogeneous and inhomogeneous articles 18C.4.2 Jewellery products . 2

22、0Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/11/2011 07:29, Uncontrolled Copy, (c) BSIBS EN 1811:2011EN 1811:2011 (E) 3 C.4.3 Other articles such as textiles, footwear, garments, leather goods and mobile phones 25C.5 Methods of determining the surface areas . 26C.5.1 Surface area measu

23、rements 26C.5.2 Minimum surface area . 26C.5.3 Simplification of surface area determination using common shapes of consumer products . 26C.6 Testing apparatus prior to nickel release testing 26Annex D (informative) Articles made from composite materials . 28Bibliography 29Licensed Copy: Wang Bin, IS

24、O/EXCHANGE CHINA STANDARDS, 14/11/2011 07:29, Uncontrolled Copy, (c) BSIBS EN 1811:2011EN 1811:2011 (E) 4 Foreword This document (EN 1811:2011) has been prepared by Technical Committee CEN/TC 347 “Methods for analysis of allergens”, the secretariat of which is held by DS. This European Standard shal

25、l 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 March 2013. Attention is drawn to the possibility that some of the elements of this docu

26、ment 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 16128:2011, supersedes EN 1811:1998 +A1:2008. This document has been prepared under a mandate given to CEN by the European Commiss

27、ion 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 changes that have been made in this new version of EN 1811 in comparison with th

28、e 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 frames and sunglasses; List of the significant technical changes of EN 1811:2011 as

29、 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 correction factor was eliminated and the concept of measurement uncertainty intro

30、duced; 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. According to the CEN/CENELEC Internal Regulations, the national standards organization

31、s 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, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

32、Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom., Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/11/2011 07:29, Uncontrolled Copy, (c) BSIBS EN 1811:2011EN 1811:2011 (E) 5 Introduction Adverse skin reaction to nickel has been known for many decades. Nickel i

33、s the most frequent cause of contact allergy in Europe, and 10 % to 20 % of the patch tested female population and 1 % to 3 % of the patch tested male population are allergic to nickel. Skin absorption of nickel ions, which are released from some nickel-containing materials which are inserted into p

34、ierced ears or other pierced parts of the human body or which are in direct and prolonged contact with 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 t

35、he 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 introduction of a number of measures designed to reduce its prevalence. These measures include the requirements of th

36、is standard which provides an in-vitro chemical test that correlates as far as possible with the variable human biological reactions that occur when metallic articles containing nickel are in direct and prolonged contact with the skin and pierced parts of the body. The standard provides a measure of

37、 the amount of nickel release from an article immersed for one week in artificial sweat. The standard also describes the preparation of a quality control material intended to assist a laboratory in achieving an acceptable precision. Clinical patch-testing of a small selection of nickel-containing al

38、loys 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 migration limit of 0,5 g/cm2/week for articles intended to come into direct and prolonged contact with the

39、skin and a nickel migration limit of less than 0,2 g/cm2/week for all post piercing assemblies inserted into pierced ears and other pierced parts of the human body has been set in Commission Regulation (EC) No 1907/2006 of the European Parliament and the Council (in the current version). Licensed Co

40、py: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 14/11/2011 07:29, Uncontrolled Copy, (c) BSIBS EN 1811:2011EN 1811:2011 (E) 6 1 Scope This European Standard specifies a method for simulating the release of nickel from all post assemblies which are inserted into pierced ears and other pierced parts of th

41、e human body and articles intended to come into direct and prolonged contact with the skin in order to determine whether such articles are in compliance with No. 27 Annex XVII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH). Spectacle frames and sunglasses are e

42、xcluded from the scope of this European Standard. NOTE Spectacle frames and sunglasses are subject to the requirements of EN 16128:2011 which provides an unchanged re-publication of the technical requirements that had previously been specified in EN 1811:1998, but restricted in scope to apply only t

43、o spectacle frames and sunglasses. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments)

44、applies. EN 12472, Method for the simulation of wear and corrosion for the detection of nickel release from coated items EN ISO 3696:1995, Water for analytical laboratory use Specification and test methods (ISO 3696:1987) 3 Terms and definitions For the purposes of this document, the following terms

45、 and definitions apply. 3.1 barrette component used to secure the watchstrap to the case 3.2 homogeneous consisting of a single material having a common surface finish 3.3 post assembly ear stud or body piercing article 3.4 release solution solution resulting from the release procedure according to

46、8.2 3.5 representative best estimate for the effective release rate of all surfaces which are in direct and prolonged contact with the skin or pierced parts of the body under normal conditions of use NOTE This property is defined with respect to the release rate. Licensed Copy: Wang Bin, ISO/EXCHANG

47、E CHINA STANDARDS, 14/11/2011 07:29, Uncontrolled Copy, (c) BSIBS EN 1811:2011EN 1811:2011 (E) 7 3.6 sample area a surface(s) that is(are) immersed in the test solution and not covered with a masking agent 3.7 test solution solution as prepared according to 8.1 3.8 watch crown winder used to alter t

48、he time/date 4 Principle of the procedure The article to be tested for nickel release is placed in an artificial sweat test solution for one week. The concentration of dissolved nickel in the solution is determined by an appropriate analytical method, for example inductively-coupled plasma spectrome

49、try. The nickel release is expressed in micrograms per square centimetre per week (g/cm2/week). NOTE Indicative information on the extent of nickel release can be obtained by performing one of the tests specified in CR 12471. 5 Reagents Except where indicated, all reagents shall be of recognized pro analysis, p.a., grade or better and shall be free of nickel. 5.1 Deionis