EN ISO 13897-2004 en Dentistry - Amalgam capsules《牙科学 汞齐合金胶囊 ISO 13897-2003》.pdf

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1、BRITISH STANDARD BS EN ISO 13897:2004 Incorporating corrigendum no. 1 Dentistry Amalgam capsules The European Standard EN ISO 13897:2004 has the status of a British Standard ICS 11.060.10 BS EN ISO 13897:2004 This British Standard was published under the authority of the Standards Policy and Strateg

2、y Committee on 8 June 2004 BSI 2007 ISBN 978 0 580 59987 3 National foreword This British Standard is the UK implementation of EN ISO 13897:2004. It is identical with ISO 13897:2003, incorporating corrigendum December 2003. The UK participation in its preparation was entrusted by Technical Committee

3、 CH/106, Dentistry, to Subcommittee CH/106/6, Dental equipment. A list of organizations represented on this subcommittee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applica

4、tion. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. Date Comments 17322 Corrigendum No. 1 28 September 2007 Change to subclause 7.3.5.2EUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO13897 May2004 ICS11.060.10 Engli

5、shversion DentistryAmalgamcapsules(ISO13897:2003) ArtdentaireCapsulespouramalgame(ISO13897:2003) ZahnheilkundeAmalgamkapseln(ISO13897:2003) ThisEuropeanStandardwasapprovedbyCENon1April2004. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope

6、an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagema

7、debytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Lat

8、via,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2004CEN Allrightsofexploitationin

9、anyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO13897:2004EINESO31:7982004(E) 2 Foreword ThetextofISO13897:2003hasbeenpreparedbyTechnicalCommitteeISO/TC106 “Dentistry”oftheInternationalOrganizationforStandardization(ISO)andhasbeentaken overasENISO13897:2004byTechnicalCommitt

10、eeCEN/TC55“Dentistry“,thesecretariat ofwhichisheldbyDIN. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublication ofanidenticaltextorbyendorsement,atthelatestbyNovember2004,andconflicting nationalstandardsshallbewithdrawnatthelatestbyNovember2004. AccordingtotheCEN/CENELECInt

11、ernalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary, Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland, Portugal,S

12、lovakia,Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. Endorsementnotice ThetextofISO13897:2003hasbeenapprovedbyCENasENISO13897:2004withoutany modifications. NOTENormativereferencestoInternationalStandardsarelistedinAnnexZA(normative). ENISO13897:2004 Reference number ISO 13897:2003(E)INTERNATIO

13、NAL ADNATSDR ISO 17983 tide tsriFino 0-300251-2 Dentistry Amalgam capsules Art dentaire Capsules pour amalgame Referecne unmebr OSI 79831002:)E(3INTERNATIONAL STANDARD ISO 13897 First edition 2003-02-15 itneDsrty Ammagla spacusel rAed tatnir e spaCulse pruo malamage ENISO13897:2004IS:79831 O3002(E)

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17、SO13897:2004ISO 13897:2003(E) iiiForeword 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 member body inte

18、rested 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 Electrotechnica

19、l 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 adopted by the t

20、echnical 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 patent rights. I

21、SO shall not be held responsible for identifying any or all such patent rights. ISO 13897 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment. ENISO13897:2004ISO 13897:2003(E) iv Introduction In order to produce dental amalgam, electrically powered amalgama

22、tors as described in ISO 7488 are primarily used for mixing (trituration) of amalgam alloys with mercury. In many amalgamators, a removable capsule is used to contain the alloy and mercury. Although the capsule must be considered as part of the amalgamator when in use or under test, the requirements

23、 for capsules are not dealt with in ISO 7488. These requirements are the subject of this International Standard. ENISO13897:2004INTENRATIONAL TSANDADR IS:79831 O3002(E)1Dentistry Amalgam capsules 1 Scope This International Standard specifies requirements and test methods for predosed capsules and fo

24、r reusable capsules used for mixing dental amalgam alloys and mercury. 2 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

25、document (including any amendments) applies. ISO 1559:1995, Dental materials Alloys for dental amalgam ISO 1560, Dental mercury ISO 1942-2, Dental vocabulary Part 2: Dental materials ISO 7488:1991, Dental amalgamators ISO 8601, Data elements and interchange formats Information interchange Representa

26、tion of dates and times 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1559, ISO 1942-2, ISO 7488 and the following apply. 3.1 predosed capsule single-use capsule supplied containing separated measured amounts of alloy powder and mercury in such a w

27、ay that premature contact is prevented 3.2 self-activating capsule predosed capsule in which contact between the alloy powder and mercury occurs automatically during amalgamation 3.3 activation action that renders the contained alloy powder and mercury mixable 4 Classification Amalgam capsules cover

28、ed by this International Standard shall be classified as follows, according to the reusability of the mixing capsule: Type 1: predosed mixing capsule Type 2: reusable mixing capsule ENISO13897:2004ISO 13897:2003(E) 2 5 Requirements 5.1 Package and capsule contamination The packaging container and th

29、e outer surface of Type 1 capsules shall be free of mercury and/or alloy powder contamination when tested in accordance with 7.1. 5.2 Dimensions 5.2.1 Length tolerance The overall length of activated Type 1 capsules and of Type 2 capsules shall be within 1 mm of the length specified by the manufactu

30、rer. Testing shall be carried out in accordance with 7.2. 5.2.2 Diameter tolerance The maximum external diameter of Type 1 and Type 2 capsules shall be within 0,5 mm of the diameter specified by the manufacturer. Testing shall be carried out in accordance with 7.2. 5.3 Loss of mass 5.3.1 General The

31、 loss in mass for Type 1 and Type 2 capsules during amalgamation shall not exceed 0,5 mg. Testing shall be carried out in accordance with 7.3. 5.3.2 Type 1 capsules Type 1 capsules shall contain dental amalgam alloy and dental mercury which meet the following requirements: the dental amalgam alloy s

32、hall conform to ISO 1559; the dental mercury shall conform to ISO 1560. 5.3.3 Type 2 capsules Type 2 capsules shall be tested using dental amalgam alloy and dental mercury which meet the following requirements: the dental amalgam alloy shall conform to ISO 1559; the dental mercury shall conform to I

33、SO 1560. 5.4 Mercury and alloy retention The mass of the retained material found within Type 1 and Type 2 capsules after amalgamation shall not exceed 1 % of the mass of alloy and mercury. Testing shall be carried out in accordance with 7.4. ENISO13897:2004ISO 13897:2003(E) 36 Sampling A sufficient

34、number of capsules to perform all tests shall be obtained from a single manufactured batch. 7 Test methods 7.1 Package and capsule contamination (Type 1 capsules only) 7.1.1 Apparatus 7.1.1.1 Stereomicroscope with 8x magnification. 7.1.2 Procedure Visually examine both the primary package or contain

35、er and 25 randomly selected capsules under a magnification of 8. 7.2 Dimensions 7.2.1 Apparatus 7.2.1.1 Micrometer or an optical comparator, having an accuracy of 0,05 mm. 7.2.2 Procedure Test 10 samples of the capsules. For Type 1 capsules, other than self-activating units, activate each sample but

36、 do not amalgamate before the test. Measure and record the overall length of each capsule. Determine the location of the largest diameter, measure and record each result. 7.2.3 Pass/fail determination The length and diameter of all 10 capsules shall meet the requirements specified in 5.2.1 and 5.2.2

37、. 7.3 Loss of mass 7.3.1 Apparatus 7.3.1.1 Amalgamator in accordance with ISO 7488 and tested using a strobe light as specified in ISO 7488:1991, 7.3, to ensure that the stated oscillation frequency is obtained. 7.3.1.2 Laboratory balance with an accuracy of 0,05 mg. 7.3.1.3 Pliers, needle-nosed typ

38、e. 7.3.1.4 Brush having soft bristles. 7.3.2 Procedure for Type 1 capsules Select five capsules at random and test each as follows. Before amalgamation, remove any loose material from the surface of each capsule and weigh each capsule to the nearest 0,1 mg. Amalgamate in accordance with ISO 1559:199

39、5, 6.1.2. After amalgamation, allow each capsule to cool to room temperature for 1 h and then reweigh it to the nearest 0,1 mg. 7.3.3 Procedure for Type 2 capsules Fill each of five randomly selected capsules with 600 mg alloy powder and add the mass of mercury specified by the manufacturer for this

40、 mass of alloy. Close the capsule, remove any loose material from the surface, and weigh to the nearest 0,1 mg. Amalgamate in accordance with ISO 1559:1995, 6.1.2. After amalgamation, ENISO13897:2004ISO 13897:2003(E) 4 allow the capsule to cool to room temperature for 1 h and then reweigh it to the

41、nearest 0,1 mg. Using the same capsules, repeat the test for each capsule four more times. 7.3.4 Calculation of results Calculate the loss of mass as capsule mass before amalgamation minus capsule mass after amalgamation. 7.3.5 Pass/fail determinations 7.3.5.1 Type 1 capsules Five out of five capsul

42、es or 14 out of the 15 capsules shall meet the requirements of 5.3. 7.3.5.2 Type 2 capsules 7.4 Mercury/alloy retention 7.4.1 Type 1 capsules 7.4.1.1 Procedure Use the apparatus specified in 7.3.1. Select five capsules at random and test each as follows. Weigh each capsule to the nearest 1 mg as m 1

43、 . Amalgamate for the time and at the frequency recommended by the alloys manufacturer. Remove the capsule from the amalgamator, open the capsule, and empty the amalgam into a receptacle. Weigh the capsule components to the nearest 1 mg as m 2 . If necessary, use pliers to separate all capsule compo

44、nents and then brush out all retained material. Reweigh the capsule components to the nearest 1 mg as m 3 . 7.4.1.2 Calculation of results The difference (m 2 m 3 ) is the mass of alloy and mercury retained. Calculate the retained mass of alloy and mercury, m, as percentage of the initial mass of al

45、loy and mercury for each capsule to the nearest 0,05 %, using the following equation () 23 13 100 () mm m mm = where m 1is the capsule mass before amalgamation; m 2is the mass of the capsule components after amalgamation; m 3is the mass of the capsule components after amalgamation and after brushing

46、 out all retained material. 7.4.1.3 Pass/fail determinations If one of five capsules fails the test, test 10 more capsules. Five out of five capsules or 14 out of the 15 capsules shall meet the requirements of 5.4. IC.11 S.06001 feR. .oN ISO :79831/3002.roC:1(3002)E ISA 3002 Oll irthgs serdevre NIRE

47、TNANOITAL ATSNDARD 3002:79831 OSI TEACINHCL EGIRROC1 MUDN silbuP-3002 deh-2151 INETANRITONAL ORGAINAZITON OFS RTAADNIDRAZITON ORGAINSATION INTERNATIONALEED ON MRALISATIONyrtsitneDA mmagla capsules TECHNICALEGIRROC 1 MUDN rAriatned tespaC seluruop amemagla 1 EUQINHCET FITACIFITCER TceinhcroC lariudnegm OSI ot 1 w 3002:79831asrp rapeyb de TcecinhmoC lami eettOSI/TC ,601sitneDrty , cSubmomittee SC 6, Dental equipment. age 4 P 7.3.5.2 Typpe 2 casules eplacRe the first scnetenw eif eht htlloowing new sencnete. If one of the five tests of any of the capsules fails, test 10 m