DIN EN ISO 10873-2010 Dentistry - Denture adhesives (ISO 10873 2010) German version EN ISO 10873 2010《牙科学 假牙粘合剂(ISO 10873-2010) 德文版本EN ISO 10873-2010》.pdf

1、December 2010 Translation by DIN-Sprachendienst.English price group 12No 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).I

2、CS 71.100.70!$ld.“1736511www.din.deDDIN EN ISO 10873Dentistry Denture adhesives (ISO 10873:2010)English translation of DIN EN ISO 10873:2010-12Zahnheilkunde Prothesenhaftmittel (ISO 10873:2010)Englische bersetzung von DIN EN ISO 10873:2010-12Mdecine bucco-dentaire Adhsifs pour prothses dentaires (IS

3、O 10873:2010)Traduction anglaise de DIN EN ISO 10873:2010-12www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.2012.10 DIN EN ISO 10873:2010-12 2 A comma is used as the decimal marker. National foreword This standard has been prepared

4、 by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-19 AA Mundpf

5、legeprodukte. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 3696 DIN ISO 3696 ISO 7823-2 DIN EN ISO 7823-2 ISO 8601 DIN EN 28601 National Annex NA (informative) Bibliography DIN EN 28601, Data elements and int

6、erchange formats Information interchange Representation of dates and times DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 7823-2, Plastics Poly(methyl methacrylate) sheets Types, dimensions and characteristics Part 2: Extruded sheets DIN ISO 3696, Water for analytical laboratory use Specification

7、and test methods EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10873 September 2010 ICS 97.170 English Version Dentistry - Denture adhesives (ISO 10873:2010) Mdecine bucco-dentaire - Adhsifs pour prothses dentaires (ISO 10873:2010) Zahnheilkunde - Prothesenhaftmittel (ISO 10873:2010) This

8、 European Standard was approved by CEN on 11 September 2010. 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 refer

9、ences concerning such national standards may be obtained on application to the CEN 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

10、into its own language and notified to the CEN 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, I

11、taly, Latvia, Lithuania, Luxembourg, 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-1

12、000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10873:2010: EContents DIN EN ISO 10873:2010-12 EN ISO 10873:2010 (E) 2 Page Foreword3 1 Scope 4 2 Normative references 4 3 Terms and definitions .4 4 Classificat

13、ion5 5 Requirements.5 5.1 General5 5.2 Specific requirements for Type 1 adhesives 5 5.3 Specific requirements for Type 2 adhesives 5 6 Sampling.6 7 Test methods6 7.1 Test conditions 6 7.2 pH value measurement .6 7.3 Determination of stability Aging procedure .7 7.4 Test of washability (for Type 1 ad

14、hesives) .7 7.5 Adhesion strength test I (for Type 1 adhesives) 7 7.6 Adhesion strength test II (for Type 1 adhesives) .10 7.7 Adhesion strength test (for Type 2 adhesives) 11 7.8 Peeling test (for Type 2 adhesives)13 7.9 Consistency test (for Type 2 adhesives).14 7.10 Assessment15 8 Accompanying in

15、formation 16 8.1 Information to be included in the manufacturers instructions 16 8.2 Labelling on the package17 Bibliography 18 Foreword This document (EN ISO 10873:2010) has been prepared by Technical Committee ISO/TC 106 Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” th

16、e 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 March 2011, and conflicting national standards shall be withdrawn at the latest by March 2011. Attention is d

17、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. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the follo

18、wing 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, Romania, Slova

19、kia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10873:2010 has been approved by CEN as a EN ISO 10873:2010 without any modification. “DIN EN ISO 10873:2010-12 EN ISO 10873:2010 (E) 3 1 Scope This International Standard classifies denture adhesives

20、 used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products. This International Standard is applicable to denture adhesives for use by the public and excludes the dental lining materials prescribed or applied by de

21、ntal professionals. This International Standard does not specify qualitative or quantitative requirements for freedom from biological hazards. For assessing possible biological hazards, see ISO 7405and ISO 10993-1. 2 Normative references The following referenced documents are indispensable for the a

22、pplication 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 1942, Dentistry Vocabulary ISO 3696, Water for analytical laboratory use Specification and test methods ISO

23、 7823-2, Plastics Poly(methyl methacrylate) sheets Types, dimensions and characteristics Part 2 Extruded sheets ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times 3 Terms and definitions For the purposes of this document, the terms and definitio

24、ns given in ISO 1942 and the following apply. 3.1 denture adhesives dental product placed on the intaglio surface (fitting surface) of a removable denture to temporarily improve its retention to soft supporting tissues 3.2 glue type denture adhesive in powder, cream, sheet or tape form with water-so

25、luble polymer as adhesive constituent 3.3 liner type denture adhesive in non-aqueous paste form DIN EN ISO 10873:2010-12 EN ISO 10873:2010 (E) 4 4 Classification For the purposes of this International Standard, denture adhesives are categorized as one of the following types: a) Type 1: glue type: Cl

26、ass 1: powder form; Class 2: cream form; Class 3: sheet or tape form. b) Type 2: liner type. 5 Requirements 5.1 General 5.1.1 Biocompatibility Particular attention should be given to assessing the effects on biocompatibility from the release of metallic ions from the denture adhesive. 5.1.2 pH value

27、 Denture adhesives shall have a pH value within the range of 4 to 10 when tested in accordance with 7.2. 5.1.3 Microbiology Testing for microbiological contamination shall be carried out according to appropriate methods such as those listed in References 11 to 14or those specified in ISO 16212, ISO

28、18416, ISO 21148, ISO 21149, ISO 21150, ISO 22717, ISO 22718 and ISO 29621. 5.1.4 Stability The denture adhesive shall show no signs of deterioration which may affect compliance with this International Standard after being subjected to one of the aging procedures specified in 7.3. 5.2 Specific requi

29、rements for Type 1 adhesives 5.2.1 Washability There shall be no residual lump when tested in accordance with 7.4. 5.2.2 Strength of the adhesion to the prosthesis Adhesion strength shall not be less than 5 kPa when tested in accordance with 7.5 and 7.6. 5.3 Specific requirements for Type 2 adhesive

30、s 5.3.1 Adhesion strength Adhesion strength shall not be less than 5 kPa when tested in accordance with 7.7. DIN EN ISO 10873:2010-12 EN ISO 10873:2010 (E) 5 5.3.2 Peeling property There shall be no residual lump when tested in accordance with 7.8. 5.3.3 Consistency Consistency shall not be less tha

31、n 15 mm when tested in accordance with 7.9. 6 Sampling The sample shall be taken from one lot and shall be sufficient to complete all tests specified in Clause 7. 7 Test methods 7.1 Test conditions All tests shall be conducted at a temperature of (23 3) C. 7.2 pH value measurement 7.2.1 Apparatus an

32、d material 7.2.1.1 pH meter, with a glass and comparison electrode assembly with an accuracy of 0,02. 7.2.1.2 Glass container, of 500 ml capacity. 7.2.1.3 Circular filter paper, used to separate fine precipitates for chemical analysis. 7.2.2 Reagents 7.2.2.1 Propylene glycol, analytical grade. 7.2.2

33、.2 Water, grade 3 in accordance with ISO 3696. 7.2.3 Procedure 7.2.3.1 Type 1 adhesives 7.2.3.1.1 Class 1 and Class 2 Take (1,0 0,1) g of a Class 1 or Class 2 denture adhesive, add 5 g of propylene glycol (7.2.2.1) to disperse it, and while stirring, add 300 ml of water (7.2.2.2) and mix them suffic

34、iently. Insert the electrode of the pH meter (7.2.1.1) into the dispersion and take the pH meter reading 3 min after the insertion. 7.2.3.1.2 Class 3 Take (1,0 0,1) g of a Class 3 denture adhesive, add 300 ml of water and mix them sufficiently. Insert the electrode of the pH meter and take the pH me

35、ter reading 3 min after the insertion. 7.2.3.2 Type 2 Take (1,0 0,1) g of denture adhesive, spread evenly over a radius of approximately 40 mm on a piece of filter paper (7.2.1.3). Place the filter paper in a glass container (7.2.1.2) and add 300 ml of water to it. After immersing in water for 1 h,

36、insert the electrode of the pH meter into water and take the pH meter reading 3 min after the insertion. DIN EN ISO 10873:2010-12 EN ISO 10873:2010 (E) 6 7.3 Determination of stability Aging procedure Store the denture adhesives in their original containers at (40 2) C at (75 5) % relative humidity

37、for 3 months or at such conditions of time and temperature as will simulate storage at room temperature for 30 months15. 7.4 Test of washability (for Type 1 adhesives) 7.4.1 Apparatus and materials 7.4.1.1 Water bath, capable of being maintained at a temperature of (37 2) C. 7.4.1.2 Poly(methyl meth

38、acrylate) plate (PMMA), approximately 50 mm 50 mm, in accordance with ISO 7823-2. 7.4.2 Reagent 7.4.2.1 Water, in accordance with 7.2.2.2. 7.4.3 Procedure Apply the denture adhesive on the PMMA plate (7.4.1.2) evenly following the manufacturers instructions for use and immerse the plate in water for

39、 1 h in the water bath (7.4.1.1) maintained at (37 2) C. Wash the PMMA plate following the manufacturers instructions for use and inspect the PMMA plate surface with the naked eye, without magnification. Repeat the tests to obtain five test results. 7.5 Adhesion strength test I (for Type 1 adhesives

40、) 7.5.1 General Conduct the following adhesion strength test within 3 min after removal from the water bath. 7.5.2 Apparatus 7.5.2.1 Adhesion test instrument, having a sample stand, of capacity up to 10 N (for both frame and load cell), with a cross-head speed up to 5 mm/min. See Figure 1. DIN EN IS

41、O 10873:2010-12 EN ISO 10873:2010 (E) 7 Key 1 load detecting part 2 pressure sensitive shaft 3 denture adhesive 4 sample holder 5 sample stand NOTE This is an example of a test instrument. 12345Figure 1 Adhesion test instrument 7.5.2.2 Sample holder I, having a hole with a diameter of (22 1) mm and

42、a depth of (0,5 0,1) mm, made of poly(methyl methacrylate) complying with ISO 7823-2. See Figure 2 a). 7.5.2.3 Sample holder II, having a raised circular part with a diameter of (22 1) mm and a height of (5,0 0,1) mm made of poly(methyl methacrylate) complying with ISO 7823-2. See Figure 2 b). 7.5.2

43、.4 Pressure sensitive shaft, having a circular base with a diameter of (20,0 0,5) mm, made of poly(methyl methacrylate) complying with ISO 7823-2. See Figure 3. 7.5.2.5 Water bath, in accordance with 7.4.1.1. DIN EN ISO 10873:2010-12 EN ISO 10873:2010 (E) 8 Dimensions in millimetres 0,5 0,122 150,12

44、2 1a) Sample holder I b) Sample holder II Figure 2 Sample holders 7.5.3 Reagent 7.5.3.1 Water, in accordance with 7.2.2.2. 7.5.4 Procedure 7.5.4.1 Class 1 denture adhesive Add water (7.2.2.2) to 1 g to 3 g of a Class 1 denture adhesive powder in a powder/water mass ratio of 4 and mix them homogeneou

45、sly. Leave the mixture in a sealed container for 5 min before using it as a sample. Slightly overfill the hole of holder I (7.5.2.2) with the mixture, flatten the surface, and then immerse the sample/sample holder I assembly in water for 1 min in the water bath (7.4.1.1) maintained at (37 2) C. Take

46、 out the sample/sample holder I assembly from the water bath and shake it once to remove water from the surface. Set the sample/sample holder I assembly on the sample stand of the adhesion test instrument (7.5.2.1) so that the load is applied to the centre of the sample. Apply a load up to (9,8 0,2)

47、 N at cross-head speed of 5 mm/min by the pressure sensitive shaft (7.5.2.4) to the sample, maintain the load in the position for 30 s and pull it toward the opposite direction at cross-head speed of 5 mm/min. Record the maximum force measured by the pressure sensitive shaft and calculate the force

48、per unit area as the adhesion strength. See Figure 3 a). Repeat the test four times to obtain five results. 7.5.4.2 Class 2 denture adhesive Slightly overfill the hole of the sample holder I with a Class 2 denture adhesive, flatten the surface, and then immerse the sample/sample holder I assembly in

49、 water for 1 min in the water bath maintained at (37 2) C. Take out the sample/sample holder I assembly and shake it once to remove water from the surface. Set the sample/sample holder I assembly on the sample stand of the adhesion test instrument (7.5.2.1) so that the load is applied to the centre of the sample. Apply a load up to (9,8 0,2) N at cross-head speed of 5 mm/min by the pressure sensitive shaft to the sample, maintain the load in the position for 30 s and pull