BS-EN-24049-1992 ISO-4049-1988.pdf

BRITISH STANDARD BS EN 24049:1994 Incorporating Amendment Nos. 1 and 2 Specification for Resin-based dental filling materials (class B) The European Standard EN 24049:1993 has the status of a British Standard UDC 616.314-089.27:615.462 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 01 00:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 24049:1994 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Board of BSI and comes into effect on 31 October 1989 © BSI 10-1999 First published May 1975 First revision October 1989 The following BSI references relate to the work on this standard: Committee reference HCC/53 Draft for comment 87/53650 DC ISBN 0 580 17680 0 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/53, upon which the following bodies were represented: Association of Dental Hospitals of the United Kingdom British Dental Association British Dental Trade Association British Endodontic Society British Society for Restorative Dentistry British Society for the Study of Orthodontics Dental Materials Panel Department of Health Department of Trade and Industry (Laboratory of the Government Chemist) Department of Trade and Industry (National Physical Laboratory) Ministry of Defence Royal Society of Medicine Society of University Dental Instructors Amendments issued since publication Amd. No.Date of issueComments 7513January 1993 8267October 1994Indicated by a sideline in the margin Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 01 00:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 24049:1994 © BSI 10-1999i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Introduction3 1Scope3 2Normative references3 3Classification4 4Requirements4 5Sampling4 6Preparation of test specimens4 7Test methods5 8Packaging and marking information to be supplied by the manufacturer13 Figure 1 Apparatus for determination of working and setting times6 Figure 2 Typical recording trace showing temperature changes with time for determination of working and setting times7 Figure 3 Internal transmittance for colour conversion filter8 Figure 4 Mould (7.8.1.1) for flexural strength testing10 Figure 5 Mould (7.9.1.1) for water sorption and solubility test11 Publications referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 01 00:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 24049:1994 ii © BSI 10-1999 National foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Committee and is identical with ISO 4049:1988, “Dentistry Resin-based filling materials”, prepared by Technical Committee 106, Dentistry, of the International Organization for Standardization (ISO). In 1993 the European Committee for Standardization (CEN) accepted ISO 4049:1988 plus Technical Corrigendum 1:1992 as European Standard EN 24049:1993. This revision of BS 5199 supersedes BS 5199:1975 which is withdrawn. All the significant changes introduced are listed in the “Introduction”. The Technical Committee has reviewed the provisions of ISO 3665 to which reference is made in the text, and has decided that they are acceptable for use in conjunction with this standard. There is no corresponding British Standard for ISO/TR 7405, to which reference is made in the “Introduction” and clause 2 for information only. In the UK it is common practice to assess the biological hazards of dental materials using BS 5828:1989, “Methods for biological assessment of dental materials”. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Cross-references International StandardCorresponding British Standard ISO 7491:1985BS 6790:1987 Method for determination of colour stability of dental polymeric materials (Identical) ISO 8601:1988BS 7151:1989 Specification for representation of dates and times in information interchange (Identical) Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 14, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 01 00:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN 24049 July 1992 + A1 January 1993 + A2 October 1994 UDC 616.314-089.27:615.462 Descriptors: Dentistry, dental materials, dental cements, synthetic resins, specifications, tests, packing, marking English version Dentistry Resin-based filling materials (includes amendments A1:1993 + A2:1994) (ISO 4049:1988) Art dentaire Produits dobturation à base de résines synthétiques (inclut les amendements A1:1993 + A2:1994) (ISO 4049:1988) Zahnheilkunde Füllungswerkstoffe aus Kunststoff (enthält Änderungen A1:1993 + A2:1994) (ISO 4049:1988) This European Standard was approved by CEN on 1992-07-27. 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 references concerning such national standards may be obtained on application to the Central Secretariat 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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comité Européen de Normalisation Europäisches Komitee für Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels © 1992 Copyright reserved to CEN members Ref. No. EN 24049:1992 + A1:1993 + A2:1994 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 01 00:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 24049:1992 © BSI 10-1999 2 Foreword This European Standard has been taken over by the CEN/TC 55 “Dentistry” from work of ISO/TC 106 “Dentistry” of the International Organisation for Standardization (ISO). In the countries bound to implement this European Standard a national standard identical to this European Standard shall be published at the latest by 1993-02-28 and conflicting national standards shall be withdrawn at the latest by 1993-02-28. According to the CEN/CENELEC Common Rules, the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Foreword to Amendment A2 This European Standard is the endorsement of ISO 4049:1988 and its Technical Corrigendum 1:1992. Endorsement of ISO 4049 and its Technical Corrigendum 1 was recommended by Technical Committee CEN/TC 55 “Dentistry” under whose competence this European Standard will henceforth fall. This European Standard supersedes EN 24049:1992. 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 April 1994, and conflicting national standards shall be withdrawn at the latest by April 1994. The standard was approved and in accordance with the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 01 00:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 24049:1992 © BSI 10-19993 Introduction This second edition of ISO 4049 takes account of the considerable volume of technical information which has accumulated since the first edition was published in 1978. Some of the tests in the first edition have been omitted and others added for the reasons given below. This International Standard does not cover requirements for materials intended for the restoration of occlusal surfaces or those intended to prevent caries. In order to make this clear, a classification system has been introduced (see clause 3). This International Standard therefore covers class B materials, i.e. materials other than those intended for occlusal surfaces, and manufacturers are now required to classify their materials accordingly. Furthermore, in order to assist the purchaser, manufacturers are now also required (see clause 8) to describe the filler particle size range and the principal component of the resin base. The possibility was considered that materials might be classified by filler loading or its corollary, water uptake, and solubility of the resin phase. However collaborative testing revealed considerable overlapping of these properties in “conventional” and “microfine” materials and such a classification was not adopted. Resin-based restorative materials activated by external energy are now well established and requirements for these materials are therefore included. As the materials do not have an unlimited working time in the dental surgery, a test for sensitivity to ambient light has been included (see 7.6). Working and setting times of chemically cured materials cannot be determined accurately because of their rapid setting and varying viscosities after mixing. The test in the first edition of this International Standard, using an oscillating rheometer, had poor sensitivity and gave results that could not be correlated with “clinical” working time. In this second edition the test has been replaced by one which is simple and widely applicable. The flexural strength test (see 7.8) has been aligned with the test used for denture-base polymers by requiring that the specimen be immersed in water during testing. A requirement relating to modulus-dependent flexural strength has been included with the limiting value set to reveal conventional composites with poor filler/resin bonding. Requirements have been included for materials claimed to be radio-opaque (see 4.5). Although tests are not included in this second edition for determining non-mandatory or optional properties, such as polymerization shrinkage, it is hoped to do so in a later edition. At present more than one test may be used to determine a single such property which makes true comparisons impossible and confuses the purchaser. The test for depth of cure of external-energy-activated materials will be reviewed and revised, if necessary, when more data become available. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended that reference should be made to ISO/TR 7405 when assessing possible biological or toxicological hazards. 1 Scope This International Standard specifies requirements for dental resin-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or external energy activation, and intended for use primarily for the direct restoration of class III, IV and V cavities in the teeth, i.e. class B materials (see clause 3). This International Standard does not cover requirements for materials intended for the restoration of occlusal surfaces, i.e. class A materials (see clause 3), or materials intended to prevent caries. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards listed below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 3665:1976, Photography Intra-oral dental radiographic film Specification. ISO/TR 7405:1984, Biological evaluation of dental materials. ISO 7491:1985, Dental materials Determination of colour stability of dental polymeric materials. ISO 8601:1988, Data elements and interchange formats Information interchange Representation of dates and times. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 01 00:54:30 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 24049:1992 4 © BSI 10-1999 3 Classification For the purposes of this International Standard, dental resin-based restorative materials are classified as follows: Class A: Materials claimed by the manufacturer as suitable for the restoration of cavities involving occlusal surfaces Class B: All other materials Type 1: Chemically-cured materials, i.e. those materials where setting is effected by mixing an initiator and activator Type 2: External-energy-activated materials, i.e. those materials where setting is effected by the application of energy, such as blue light 4 Requirements 4.1 Biocompatibility See the Introduction for guidance on biocompatibility. 4.2 Physical and mechanical properties 4.2.1 General If the material is supplied by the manufacturer in pre-coloured standard shades, each shade shall be capable of satisfying the requirements specified in 4.3 appropriate to the material type. If the material is supplied for “tinting” or “blending” to the users prescription, the material shall comply with the requirements both when used alone and when used with the maximum recommended proportion of tinter or blender see 8.3 g). 4.2.2 Minimum working time, type 1 materials The working time for type 1 materials, determined in accordance with 7.4, shall be not less than 90 s. 4.2.3 Setting time, type 1 materials The setting time for type 1 materials, determined in accordance with 7.5, shall be not more than 5 min. 4.2.4 Sensitivity to ambient light, type 2 materials When tested in accordance with 7.6, there shall be no detectable change in the consistency of any of the three samples of type 2 materials after being exposed to the test light for 60 s. 4.2.5 Depth of cure, type 2 materials When determined in accordance with 7.7, the depth of cure of type 2 materials shall be not less than 2 mm, and, in any event, no more than 0,5 mm below the value state