EN ISO 10271-2011 en Dentistry - Corrosion test methods for metallic materials《牙科学 金属材料的腐蚀试验方法》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 10271:2011Dentistry Corrosion testmethods for metallic materials(ISO 10271:2011)BS EN ISO 10271:2011 BRITISH STANDARDNational forewordThis British Standard is the UK im

2、plementation of EN ISO10271:2011. It supersedes BS EN ISO 10271:2001 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/2, Prosthodontic materials.A list of organizations represented on this committee can beobtained on request to its secretary.This

3、publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 53507 9ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under th

4、e authority of theStandards Policy and Strategy Committee on 31 August 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10271 August 2011 ICS 11.060.10 Supersedes EN ISO 10271:2001English Version Dentistry - Corrosion test methods for

5、 metallic materials (ISO 10271:2011) Mdecine bucco-dentaire - Mthodes dessai de corrosion des matriaux mtalliques (ISO 10271:2011) Zahnheilkunde - Korrosionsprfverfahren fr metallische Werkstoffe (ISO 10271:2011) This European Standard was approved by CEN on 29 July 2011. CEN members are bound to co

6、mply 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 obtained on application to the CEN-CENEL

7、EC 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-CENELEC Management Centre has the

8、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, Malta, Netherlands, Norway, Poland,

9、 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 exploitation in any form and by any

10、means reserved worldwide for CEN national Members. Ref. No. EN ISO 10271:2011: EBS EN ISO 10271:2011EN ISO 10271:2011 (E) 3 Foreword This document (EN ISO 10271:2011) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry”, the

11、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 February 2012, and conflicting national standards shall be withdrawn at the latest by February 2012. Attention

12、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 supersedes EN ISO 10271:2001. According to the CEN/CENELEC Internal Regulations, t

13、he 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, Italy, Latvia, Lithuania, Luxembourg, Malta, Nethe

14、rlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10271:2011 has been approved by CEN as a EN ISO 10271:2011 without any modification. BS EN ISO 10271:2011ISO 10271:2011(E) ISO 2011 All rights reserved

15、 iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Test methods .3 4.1 Static immersion test 3 4.2 Electrochemical test6 4.3 Sulfide tarnish test (cyclic immersion) .12 4.4 Sulfide tarnish test (static immersion)14 4.5 Static immersion test wit

16、h periodic analysis16 Annex A (informative) Corrosion test method development20 Bibliography26 BS EN ISO 10271:2011ISO 10271:2011(E) iv ISO 2011 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bod

17、ies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and

18、 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives,

19、Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies cast

20、ing a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10271 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, P

21、rosthodontic materials. This second edition cancels and replaces the first edition (ISO 10271:2001), which has been technically revised, in particular by the inclusion of two additional test methods. It also incorporates Technical Corrigendum ISO 10271:2001/Cor.1:2005. BS EN ISO 10271:2011ISO 10271:

22、2011(E) ISO 2011 All rights reserved vIntroduction This International Standard was developed from the original Technical Report (ISO/TR 10271) as a result of worldwide demand for standard test methods to determine acceptability of metallic materials for oral restorations in relation to corrosion. Sp

23、ecific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended that reference be made to ISO 10993-1 and ISO 7405 for assessing possible biological or toxicological hazards. The testing of the corrosion behav

24、ior of metallic materials in dentistry is complicated by the diversity of the materials themselves, their applications and the environment to which they are exposed. Variation occurs between devices and within the same device during the exposure time. The type of corrosion behavior or effect can als

25、o vary with exposure time. Accordingly, it is not possible to specify a single test capable of covering all situations, nor is it a practical proposition to define a test for each situation. This International Standard, therefore, gives detailed procedures for test methods that have been found to be

26、 of merit as evidenced by considerable use. This second edition differs from the first edition by the addition of two new test methods. To supplement the existing static immersion test, a static immersion test with periodic analysis has been added. A major reason for the addition of this test is tha

27、t the rate of corrosion of most dental metallic materials varies over time. Thus, the aim of this supplementary test is to provide information on this variation in the corrosion of a dental metallic material. A classification scheme to interpret the rate of corrosion of a tested material with time (

28、i.e. steady, decreasing, increasing) was not included as part of the static immersion test with periodic analysis. It is intended to monitor the use of the test through appropriate working groups of ISO/TC 106 to ascertain whether a classification scheme is needed in a future revision of this Intern

29、ational Standard. To supplement the sulfide tarnish test (cyclic immersion), a sulfide tarnish test (static immersion) has also been added to this second edition of ISO 10271. This test has been used successfully for many years to evaluate the corrosion of silver alloys. In addition, an informative

30、annex (Annex A) is provided that sets out a procedure for each element of the test system such that a consistent approach can be taken for the development of further test methods. Equally, it is recognized that any element can represent only the current recommendation, but changes in the future are

31、unlikely to change the framework. It is not the purpose of this International Standard to propose corrosion test methods for specific applications or to set limits as precise as those in the standard relating to the type of product and its application. BS EN ISO 10271:2011BS EN ISO 10271:2011INTERNA

32、TIONAL STANDARD ISO 10271:2011(E) ISO 2011 All rights reserved 1Dentistry Corrosion test methods for metallic materials 1 Scope This International Standard provides test methods and procedures to determine the corrosion behavior of metallic materials used in the oral cavity. It is intended that the

33、test methods and procedures in this International Standard be referred to in the individual International Standards specifying such metallic materials. This International Standard is not applicable to instruments and dental amalgam and appliances for orthodontics. 2 Normative references The followin

34、g 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. ISO 1042, Laboratory glassware One-mark volumetric flasks ISO

35、 1942, Dentistry Vocabulary ISO 3585, Borosilicate glass 3.3 Properties ISO 3696, Water for analytical laboratory use Specification and test methods ISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution test ISO 7183, Compressed-air dryers Specifications and testing 3 Term

36、s and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 breakdown potential Epleast noble potential at which pitting or crevice corrosion, or both, initiates and propagates 3.2 corrosion physicochemical interaction between a metal

37、lic material and its environment that results in a partial or total destruction of the material or in a change of its properties BS EN ISO 10271:2011ISO 10271:2011(E) 2 ISO 2011 All rights reserved3.3 corrosion potential Ecorropen-circuit potential measured under either service conditions, or labora

38、tory conditions that closely approximate service conditions 3.4 corrosion product substance formed as a result of corrosion 3.5 crevice corrosion corrosion associated with and taking place in or near a narrow aperture or crevice 3.6 current density value of electric current per unit surface area flo

39、wing through a conductor 3.7 dynamic immersion test test in which the sample is exposed to a corrosive solution under conditions of relative motion between sample and solution 3.8 electrode potential potential difference between the sample and a reference electrode 3.9 electrolyte solution or liquid

40、 that conducts an electrical current by means of ions 3.10 open-circuit potential Eocppotential of an electrode measured with respect to a reference electrode or another electrode when no current flows 3.11 pitting corrosion localized corrosion which results in pits 3.12 potentiodynamic test test in

41、 which the electrode potential is varied at a preprogrammed rate and the relationship between current density and electrode potential is recorded 3.13 potentiostatic test test in which the electrode potential is maintained constant 3.14 sample totality of material for one type being tested, the grou

42、p of all such specimens 3.15 set subgroup of the specimens of a sample BS EN ISO 10271:2011ISO 10271:2011(E) ISO 2011 All rights reserved 33.16 specimen individual single example of an object for testing 3.17 static immersion test test in which the sample is exposed to a corrosive solution under con

43、ditions of effectively no relative motion between sample and solution 3.18 stress corrosion corrosion resulting from the combined action of static tensile stress and an electrolyte 3.19 synthetic saliva test medium that simulates the chemistry of natural saliva 3.20 tarnish surface discoloration due

44、 to the chemical reaction between a metallic material and its environment 3.21 zero-current potential potential at which cathodic and anodic currents are equal 4 Test methods 4.1 Static immersion test 4.1.1 Information required Composition, including hazardous elements, in accordance with the approp

45、riate ISO standard is required. 4.1.2 Application This is an accelerated test that is intended to provide quantitative data on the metallic ion released from metallic materials under in vitro conditions relevant to those expected in the oral cavity. 4.1.3 Reagents 4.1.3.1 Lactic acid (C3H6O3), 90 %,

46、 analytical grade. 4.1.3.2 Sodium chloride (NaCl), analytical grade. 4.1.3.3 Water, complying with grade 2 of ISO 3696. 4.1.3.4 Ethanol or methanol (C2H5OH or CH3OH), analytical grade. 4.1.3.5 Compressed air, oil- and water-free, complying with ISO 7183. 4.1.4 Apparatus 4.1.4.1 Containers, of borosi

47、licate glass, complying with ISO 3585 and with dimensions of approximately 16 mm inner diameter by 160 mm in height. 4.1.4.2 pH meter, with a sensitivity of at least 0,05 pH units. BS EN ISO 10271:2011ISO 10271:2011(E) 4 ISO 2011 All rights reserved4.1.4.3 Chemical analysis instrumentation, capable

48、of measuring ion concentration in g/ml (e.g. ICP and AAS). 4.1.4.4 Micrometer gauge, accurate to 0,01 mm. 4.1.4.5 Silicon carbide paper, complying with ISO 6344-1. 4.1.4.6 Volumetric flasks, of borosilicate glass, 1 000 ml, class A, complying with ISO 1042. 4.1.5 Solution preparation Prepare an aque

49、ous solution comprising 0,1 mol/l lactic acid and 0,1 mol/l sodium chloride immediately before use. For example, dissolve (10,0 0,1) g 90 % C3H6O3(4.1.3.1) and (5,85 0,005) g NaCl (4.1.3.2) in approximately 300 ml of water (4.1.3.3). Transfer into a 1 000 ml volumetric flask (4.1.4.6) and fill to mark. The pH shall be 2,3 0,1. If not, the solution shall be discarded and reagents checked. 4.1.6 Samples 4.1.6.1 Fabrication 4.1.6.1.1 Cast Specimens shall be cast in accordance with the manufacturers recommendations. 4.1.6.1.2