BS EN ISO 10873-2010 Dentistry Denture adhesives《牙科学 假牙粘合剂》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 10873:2010Dentistry Denture adhesivesBS EN ISO 10873:2010 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO10873:2010.The UK par

2、ticipation in its preparation was entrusted to TechnicalCommittee CH/106/7, Oral hygiene products.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are respons

3、ible for its correctapplication. BSI 2010ISBN 978 0 580 60915 2ICS 11.060.10; 97.170Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2010.Amendments issu

4、ed since publicationDate Text affectedEUROPEAN 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

5、(ISO 10873:2010) This 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

6、bibliographical references 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 responsibi

7、lity of a CEN member 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

8、, Iceland, Ireland, Italy, 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:

9、Avenue Marnix 17, B-1000 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: EBS EN ISO 10873:2010EN ISO 10873:2010 (E) 3 Foreword This document (EN ISO 10873:2010) has been prepared by Technical Committee

10、 ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry” the 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 con

11、flicting national standards shall be withdrawn at the latest by March 2011. 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 rights. According

12、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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, L

13、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, 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. BS EN ISO 10873:2010ISO

14、10873:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Classification .2 5 Requirements.2 5.1 General .2 5.2 Specific requirements for Type 1 adhesives 2 5.3 Specific requirements for Type 2 adhesives 2 6 Sampling.3 7 Tes

15、t methods .3 7.1 Test conditions 3 7.2 pH value measurement .3 7.3 Determination of stability Aging procedure.4 7.4 Test of washability (for Type 1 adhesives) .4 7.5 Adhesion strength test I (for Type 1 adhesives) 4 7.6 Adhesion strength test II (for Type 1 adhesives) .7 7.7 Adhesion strength test (

16、for Type 2 adhesives) 8 7.8 Peeling test (for Type 2 adhesives) .10 7.9 Consistency test (for Type 2 adhesives).11 7.10 Assessment .12 8 Accompanying information13 8.1 Information to be included in the manufacturers instructions13 8.2 Labelling on the package14 Bibliography15 BS EN ISO 10873:2010ISO

17、 10873:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each mem

18、ber 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 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International El

19、ectrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards ado

20、pted 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 casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of pat

21、ent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10873 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care products. BS EN ISO 10873:2010INTERNATIONAL STANDARD ISO 10873:2010(E) ISO 2010 All rights reserved 1Dentistr

22、y Denture adhesives 1 Scope This International Standard classifies denture adhesives 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 us

23、e by the public and excludes the dental lining materials prescribed or applied by dental 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

24、 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) applies. ISO 1942, Dentistry Vocabul

25、ary ISO 3696, Water for analytical laboratory use Specification and test methods ISO 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 time

26、s 3 Terms and definitions For the purposes of this document, the terms and definitions 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 tissu

27、es 3.2 glue type denture adhesive in powder, cream, sheet or tape form with water-soluble polymer as adhesive constituent 3.3 liner type denture adhesive in non-aqueous paste form BS EN ISO 10873:2010ISO 10873:2010(E) 2 ISO 2010 All rights reserved4 Classification For the purposes of this Internatio

28、nal Standard, denture adhesives are categorized as one of the following types: a) Type 1: glue type: Class 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

29、effects on biocompatibility from the release of metallic ions from the denture adhesive. 5.1.2 pH value 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

30、to appropriate methods such as those listed in References 11 to 14or those specified in ISO 16212, ISO 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 Internati

31、onal Standard after being subjected to one of the aging procedures specified in 7.3. 5.2 Specific requirements 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 le

32、ss than 5 kPa when tested in accordance with 7.5 and 7.6. 5.3 Specific requirements for Type 2 adhesives 5.3.1 Adhesion strength Adhesion strength shall not be less than 5 kPa when tested in accordance with 7.7. BS EN ISO 10873:2010ISO 10873:2010(E) ISO 2010 All rights reserved 35.3.2 Peeling proper

33、ty There shall be no residual lump when tested in accordance with 7.8. 5.3.3 Consistency Consistency shall not be less than 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

34、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 and 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,

35、used to separate fine precipitates for chemical analysis. 7.2.2 Reagents 7.2.2.1 Propylene glycol, analytical grade. 7.2.2.2 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, a

36、dd 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 sufficiently. 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

37、3 denture adhesive, add 300 ml of water and mix them sufficiently. Insert the electrode of the pH meter and take the pH meter 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

38、). 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, insert the electrode of the pH meter into water and take the pH meter reading 3 min after the insertion. BS EN ISO 10873:2010ISO 10873:2010(E) 4 ISO 2010 All rights reserved7.3 D

39、etermination of stability Aging procedure Store the denture adhesives in their original containers at (40 2) C at (75 5) % relative humidity 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 ad

40、hesives) 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 methacrylate) 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 Appl

41、y 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 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 surfac

42、e with the naked eye, without magnification. Repeat the tests to obtain five test results. 7.5 Adhesion strength test I (for Type 1 adhesives) 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,

43、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. BS EN ISO 10873:2010ISO 10873:2010(E) ISO 2010 All rights reserved 5Key 1 load detecting part 2 pressure sensitive shaft 3 denture adhesive 4 sample holder 5 sample sta

44、nd 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 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 ra

45、ised 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). 7.5.2.4 Pressure sensitive shaft, having a circular base with a diameter of (20,0 0,5) mm, made of poly(methyl methacrylate) complying with ISO 7

46、823-2. See Figure 3. 7.5.2.5 Water bath, in accordance with 7.4.1.1. BS EN ISO 10873:2010ISO 10873:2010(E) 6 ISO 2010 All rights reservedDimensions in millimetres 0,5 0,122 150,122 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

47、. 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 homogeneously. Leave the mixture in a sealed container for 5 min before using it as a sample. Slightly overfill the hole of holder

48、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 out the sample/sample holder I assembly from the water bath and shake it once to remove water from the surface. Set the

49、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 (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 calculat