EN 1811-2011 en 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、BSI 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 directand prolonged contact withthe skinBS EN 1811:2011Incorporating corrigendum May 2012BS EN 1811:2011+

2、A1:2015BS EN 1811:2011+A1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 1811:2011+A1:2015, incorporating corrigendum May 2012. It supersedes BS EN 1811:2011, which is withdrawn.The start and finish of text introduced or altered by amendment is indicated i

3、n the text by tags. Tags indicating changes to CEN text carry the number of the CEN amendment. For example, text altered by CEN amendment A1 is indicated by .The UK participation in its preparation was entrusted to Technical Committee STI/53, Specifications and test methods for jewellery and horolog

4、y.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. The British Standards Institution 2015. Published by BSI Sta

5、ndards Limited 2015ISBN 978 0 580 88663 8ICS 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/corrigenda issued since publicationD

6、ate Text affected31 July 2012 Implementation of CEN corrigendum May 2012: Clauses 5.8 and 5.9 replaced31 August 2015 Implementation of CEN amendment A1:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1811:2011+A1 July 2015 ICS 39.060 Supersedes EN 1811:2011English Version Reference test met

7、hod for release of nickel from 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 Mthode dessai de rfrence relative la libration du nickel par les assemblages de tiges qui sont introduites dans les

8、 parties perces du corps humain et les produits destins entrer 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 k

9、ommen This European Standard was approved by CEN on 5 February 2011 and includes Corrigendum 1 issued by CEN on 30 May 2012 and Amendment 1 approved by CEN on 20 June 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Europe

10、an 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 CEN member. This European Standard exists in three official versions

11、(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 versions. CEN members are the national standards bodies of Austria, Belg

12、ium, Bulgaria, Croatia, Cyprus, Czech 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, Switze

13、rland, Turkey and United Kingdom. EUROPEAN 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

14、 Members. Ref. No. EN 1811:2011+A1:2015 EEN 1811:2011+A1:2015 (E) 2 Contents Page European foreword .4 Introduction .5 1 Scope 6 2 Normative references 6 3 Terms and definitions .6 4 Principle of the procedure 7 5 Reagents .7 6 Apparatus .8 7 Samples 9 7.1 Sample area 9 7.1.1 Definition of sample ar

15、ea 9 7.1.2 Determination of sample area 9 7.1.3 Masking of areas other than sample area .9 7.2 Sample degreasing before testing .9 7.3 Quality control samples 9 8 Procedure 10 8.1 Preparation of test solution . 10 8.2 Release procedure 10 8.3 Determination of nickel 11 8.3.1 General . 11 8.3.2 Calib

16、ration solutions 11 8.3.3 Detection limit and quantification limit 11 8.3.4 Number of test samples . 11 8.3.5 Number of replicate measurements 11 8.4 Blank tests . 11 9 Calculations . 11 9.1 Nickel release 11 9.2 Interpretation of results . 12 9.2.1 General . 12 9.2.2 Conformity assessment“ 12 9.2.3

17、 Uncertainty budget . 13 10 Test report . 13 Annex A (informative) !Expanded measurement uncertainty of the test procedure and compliance assessment 14 Annex B (normative) Requirements for quality control material 16 Annex C (normative) Requirements for preparation of all post assemblies which are i

18、nserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin prior to nickel testing 18 C.1 General . 18 C.2 Requirements and principle 18 C.3 Determination of the nickel release test method . 18 C.4 Determination of surfaces coming into

19、direct and prolonged contact with the skin or pierced parts of the body . 18 BS EN 1811:2011+A1:2015EN 1811:2011+A1:2015 (E) 2 Contents Page European foreword .4 Introduction .5 1 Scope 6 2 Normative references 6 3 Terms and definitions .6 4 Principle of the procedure 7 5 Reagents .7 6 Apparatus .8

20、7 Samples 9 7.1 Sample area 9 7.1.1 Definition of sample area 9 7.1.2 Determination of sample area 9 7.1.3 Masking of areas other than sample area .9 7.2 Sample degreasing before testing .9 7.3 Quality control samples 9 8 Procedure 10 8.1 Preparation of test solution . 10 8.2 Release procedure 10 8.

21、3 Determination of nickel 11 8.3.1 General . 11 8.3.2 Calibration solutions 11 8.3.3 Detection limit and quantification limit 11 8.3.4 Number of test samples . 11 8.3.5 Number of replicate measurements 11 8.4 Blank tests . 11 9 Calculations . 11 9.1 Nickel release 11 9.2 Interpretation of results .

22、12 9.2.1 General . 12 9.2.2 Conformity assessment“ 12 9.2.3 Uncertainty budget . 13 10 Test report . 13 Annex A (informative) !Expanded measurement uncertainty of the test procedure and compliance assessment 14 Annex B (normative) Requirements for quality control material 16 Annex C (normative) Requ

23、irements 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 18 C.1 General . 18 C.2 Requirements and principle 18 C.3 Determination of the nickel release

24、test method . 18 C.4 Determination of surfaces coming into direct and prolonged contact with the skin or pierced parts of the body . 18 EN 1811:2011+A1:2015 (E) 3 C.4.1 Procedures for homogeneous and inhomogeneous articles . 18 C.4.1.1 General . 18 C.4.1.2 Homogeneous articles and all post assemblie

25、s 19 C.4.1.3 Procedure for inhomogeneous articles 19 C.4.1.3.1 General 19 C.4.1.3.2 Situation 1 . 19 C.4.1.3.2.1 General 19 C.4.1.3.2.2 Procedure 1 . 19 C.4.1.3.2.3 Result . 19 C.4.1.3.3 Situation 2 . 19 C.4.1.3.3.1 General 19 C.4.1.3.3.2 Procedure 2 . 19 C.4.1.3.3.3 Result . 20 C.4.1.3.4 Situation

26、3 . 20 C.4.1.3.4.1 General 20 C.4.1.3.4.2 Procedure 3 . 20 C.4.2 Jewellery products 20 C.4.2.1 General . 20 C.4.2.2 Post assemblies and associated parts . 20 C.4.2.2.1 Parts coming into direct and prolonged contact with the skin and/or pierced parts of the body 20 C.4.2.2.2 Decorative attachments of

27、 post assemblies . 21 C.4.2.3 Necklaces, bracelets, chains and anklets . 22 C.4.2.4 Bangles . 23 C.4.2.5 Rings . 23 C.4.2.6 Watches 24 C.4.2.6.1 General 24 C.4.2.6.2 Parts to be tested . 24 C.4.2.6.3 Parts to be removed from watch before testing . 25 C.4.3 Other articles such as textiles, footwear,

28、garments, leather goods and mobile phones 25 C.5 Methods of determining the surface areas . 26 C.5.1 Surface area measurements 26 C.5.2 Minimum surface area . 26 C.5.3 Simplification of surface area determination using common shapes of consumer products . 26 C.6 Testing apparatus prior to nickel rel

29、ease testing 26 Annex D (informative) Articles made from composite materials . 28 Bibliography 29 BS EN 1811:2011+A1:2015EN 1811:2011+A1:2015 (E) 4 European foreword This document (EN 1811:2011+A1:2015) has been prepared by Technical Committee CEN/TC 347 “Methods for analysis of allergens”, the secr

30、etariat of which is held by !SNV“. 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 January 2016, and conflicting national standards shall be withdrawn at the latest by January 2016. Attention is d

31、rawn 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 includes Corrigendum 1 issued by CEN on 30 May 2012 and Amendment 1 approved by CEN on

32、 20 June 2015. This document supersedes !EN 1811:2011“. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. The modifications of the related CEN Corrigendum have been implemented at the appropriate places in the text and are indicated by the tags null

33、 null. This 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. !deleted text“ Accordin

34、g 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, Gr

35、eece, 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 1811:2011+A1:2015EN 1811:2011+A1:2015 (E) 4 European foreword This document (EN 1811:2011

36、+A1:2015) has been prepared by Technical Committee CEN/TC 347 “Methods for analysis of allergens”, the secretariat of which is held by !SNV“. 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 Januar

37、y 2016, and conflicting national standards shall be withdrawn at the latest by January 2016. 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 r

38、ights. This document includes Corrigendum 1 issued by CEN on 30 May 2012 and Amendment 1 approved by CEN on 20 June 2015. This document supersedes !EN 1811:2011“. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. The modifications of the related CEN

39、 Corrigendum have been implemented at the appropriate places in the text and are indicated by the tags null null. This 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 Commissi

40、on Regulation (EC) No 1907/2006 (REACH) of the European Parliament and the Council. !deleted text“ 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, Cy

41、prus, Czech 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 the Unit

42、ed Kingdom. EN 1811:2011+A1:2015 (E) 5 Introduction Adverse skin reaction to nickel has been known for many decades. Nickel is 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

43、to nickel. Skin absorption of nickel ions, which are released from some nickel-containing materials which are inserted into pierced 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

44、 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 sensitivity to nickel between individuals. This widespread health problem has for

45、ced the introduction of a number of measures designed to reduce its prevalence. These measures include the requirements of this 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 containi

46、ng nickel are in direct and prolonged contact with the skin and pierced parts of the body. The standard provides a measure of 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

47、assist a laboratory in achieving an acceptable precision. Clinical patch-testing of a small 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. M

48、oreover, a nickel migration limit of 0,5 g/cm2/week for articles intended to come into direct and prolonged contact with the 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 se

49、t in Commission Regulation (EC) No 1907/2006 of the European Parliament and the Council (in the current version). BS EN 1811:2011+A1:2015EN 1811:2011+A1:2015 (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 the 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 Europe