DIN EN 1811-2015 en 4147 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 .pdf

1、October 2015 Translation by DIN-Sprachendienst.English price group 14No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC

2、S 39.060!%FmU“2357450www.din.deDIN EN 1811Reference 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 direct and prolonged contact with the skin;English version EN 1811:2011+A1:2015,English translatio

3、n of DIN EN 1811:2015-10Referenzprfverfahren 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;Englische Fassung EN 1811:2011+A1:2015,Englische bersetzung von DIN EN 181

4、1:2015-10Mthode dessai de rfrence relative la libration du nickel par les assemblages de tiges que sont introduites dans les parties perces du corps humain et les produits destins entrer en contact direct et prolong avec la peau;Version anglaise EN 1811:2011+A1:2015,Traduction anglaise de DIN EN 181

5、1:2015-10SupersedesDIN EN 1811:201210www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.DDocument comprises 31 pages 09.15DIN EN 1811:2015-10 2 A comma is used as the decimal marker. National foreword This document (EN 1811:2011+A1:2015) has been prepared by

6、 Technical Committee CEN/TC 347 “Methods for analaysis of allergens”. (Secretariat: SNV, Switzerland). The responsible German body involved in its preparation was the DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-04-07 A

7、A Analyseverfahren fr Allergene. This document is the consolidated version of EN 1811:2011. It incorporates Corrigendum EN 1811/AC:2012 and Amendment EN 1811/A1:2015. The modifications of the related CEN Corrigendum have been implemented at the appropriate places in the text and are indicated by the

8、 tags nullnull. The start and finish of text introduced or altered by amendment is indicated in the text by the tags !“. Amendments This standard differs from DIN EN 1811:2012-10 as follows: a) Amendment 1:2015 has been incorporated in the standard; b) in Clause 9.2.2 the conformity assessment of th

9、e product with the legal provisions has been introduced instead of the assessment of non-compliance with the migration limits; c) Annex A has been revised and the description of cases I to IV has been deleted. Reference is made to the legally admissible nickel release value instead of the migration

10、limit; d) the bibliography has been updated; e) the German translation has been corrected. Previous editions DIN EN 1811: 1999-01, 2008-06, 2011-05, 2012-10 DIN EN 1811 Corrigendum 1: 2008-09 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1811:2011+A1 July 2015 ICS 39.060 Supersedes EN 1811:20

11、11English Version 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 direct and prolonged contact with the skin Mthode dessai de rfrence relative la libration du nickel par les assemblages de

12、 tiges qui sont introduites dans les 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

13、und lnger mit der Haut in Berhrung kommen 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 t

14、he 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 CEN member. This European Standar

15、d 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 versions. CEN members are the nation

16、al standards bodies of Austria, Belgium, 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, Slova

17、kia, Slovenia, Spain, Sweden, Switzerland, 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

18、 reserved worldwide for CEN national 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

19、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 8.3 Determination of nick

20、el 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 . 12 9.2.1 General . 12 9

21、.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) Requirements for preparatio

22、n 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 test method . 18 C.4 De

23、termination of surfaces coming into direct and prolonged contact with the skin or pierced parts of the body . 18 DINEN 1811:2015-10EN 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 assemblies 19

24、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 3 . 2

25、0 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 post

26、 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, garme

27、nts, 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 release

28、testing 26 Annex D (informative) Articles made from composite materials . 28 Bibliography 29 DIN EN 1811:2015-10 EN 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 secretariat

29、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 drawn to

30、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 20 June

31、 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 null. T

32、his 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“ According to the

33、 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, Greece, Hu

34、ngary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DINEN 1811:2015-10EN 1811:2011+A1:2015 (E) 5 Introduction Adverse skin reaction to nickel has been know

35、n 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 to nickel. Skin absorption of nickel ions, which are released from some nickel-containing materia

36、ls 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 results in allergic contact dermatitis. It is known that sensitisation to nickel requires higher

37、 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 introduction of a number of measures designed to reduce its prevalence. These measures in

38、clude 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 containing nickel are in direct and prolonged contact with the skin and pierced parts of the body. The st

39、andard 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 assist a laboratory in achieving an acceptable precision. Clinical patch-testing of a small selec

40、tion 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 migration limit of 0,5 g/cm2/week for articles intended to come into direct and

41、 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 set in Commission Regulation (EC) No 1907/2006 of the European Parliament and the Council (in the c

42、urrent version). DIN EN 1811:2015-10 EN 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

43、 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 excluded from the scope of this European Standard. NOTE Spe

44、ctacle 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 to spectacle frames and sunglasses. 2 Normative references

45、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) applies. EN 12472, Method for the simulation of wear and c

46、orrosion 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 and definitions apply. 3.1 barrette component used to sec

47、ure 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 8.2 3.5 representative best estimate for the effective rel

48、ease 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. DIN EN 1811:2015-10 EN 1811:2011+A1:2015 (E)7 3.6 sample area a surface(s) that is(are) immers

49、ed 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 the 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 spectrometry. The nickel release is expressed in micrograms per square centimetre per week (