EN ISO 13897-2018 en Dentistry - Dental amalgam reusable mixing-capsules.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018)BS EN ISO 13897:2018National forewordThis British Standard is the UK implementation of EN ISO 13897:2018. It is identical to ISO 13897:2018. It superse

2、des BS EN ISO 13897:2004, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to

3、include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 90203 1ICS 11.060.10Compliance with a British Standard cannot confer immunity from legal obligations. Th

4、is British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 13897:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 13897February 2018ICS 11.060

5、.10 Supersedes EN ISO 13897:2004EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 13897:2018: EAll rights of exploitation in any form and by any means reserved wo

6、rldwide for CEN national MembersDentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018)Mdecine bucco-dentaire - Capsules de mlange rutilisables pour amalgame dentaire (ISO 13897:2018)Zahnheilkunde - Wiederverwendbare Mischkapseln fr zahnrztliches Amalgam (ISO 13897:2018)This European St

7、andard was approved by CEN on 2 February 2018.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 concernin

8、g such national standards may be obtained on application to the CEN-CENELEC 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

9、 own language and notified to the CEN-CENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany

10、, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 13897:2018 (E)European forewordThis document (EN ISO 13897:2018) h

11、as been prepared by Technical Committee 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

12、, at the latest by August 2018, and conflicting national standards shall be withdrawn at the latest by August 2018.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such p

13、atent rights.This document supersedes EN ISO 13897:2004.According 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, Fin

14、land, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe te

15、xt of ISO 13897:2018 has been approved by CEN as EN ISO 13897:2018 without any modification.2BS EN ISO 13897:2018ISO 13897:2018Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 Dimensions . 24.1.1 Length tolerance 24.1.2 Diameter tolerance 24.

16、2 Loss of mass from the mixing-capsule during mixing. 24.3 Retention of dental amalgam in the mixing-capsule 25 Sampling 26 Measurements and test methods 26.1 Dimensions . 26.1.1 Apparatus . 26.1.2 Test sample . 36.1.3 Procedure . 36.1.4 Report 36.2 Loss of mass from the mixing-capsule during mixing

17、. 36.2.1 Principle 36.2.2 Test sample . 36.2.3 Apparatus . 36.2.4 Test procedure . 46.2.5 Expression of the results . 56.2.6 Report 56.3 Retention of dental amalgam in the mixing-capsule 66.3.1 Principle 66.3.2 Test sample . 66.3.3 Apparatus . 66.3.4 Test procedure . 66.3.5 Expression of the results

18、 . 76.3.6 Additional testing 86.3.7 Report 87 Labelling 8Bibliography 9 ISO 2018 All rights reserved iiiContents PageBS EN ISO 13897:2018ISO 13897:2018ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work

19、 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 non-governmen

20、tal, 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.The procedures used to develop this document and those intended for its further maintenance are described in the

21、ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibi

22、lity 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of p

23、atent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to co

24、nformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6,

25、Dental equipment.This second edition cancels and replaces the first edition (ISO 13897:2003) including Technical Corrigendum 1 (ISO 13897:2003/Cor.1:2003), which has been technically revised.The main changes compared to the previous edition are as follows: the scope has been revised and is now restr

26、icted to dental amalgam reusable mixing-capsules; classification into two types has been deleted; labelling requirements have been updated. requirements for single-use capsules are now within the scope of ISO 20749:2017, these being: the requirement for surface contamination of the package and the c

27、apsule for pre-capsulated dental amalgam alloy products; loss of mass during mixing from single-use capsules; the requirement for containers in which single-use capsules are supplied to prevent spillage of dental mercury leaking from faulty or damaged single-use capsules; labelling requirements for

28、pre-capsulated dental amalgam products; manufacturers instructions regarding conditions of storage and the disposal of single-use capsules in pre-capsulated dental amalgam products.iv ISO 2018 All rights reservedBS EN ISO 13897:2018ISO 13897:2018IntroductionIn order to produce dental amalgam, an ele

29、ctrically-powered mixing machine, as described in ISO 7488 is used for mixing dental amalgam alloy powder with dental mercury. In addition, a removable mixing-capsule is used to contain the dental amalgam alloy and the dental mercury during the mixing process.NOTE Traditionally, the mixing machine f

30、or dental amalgam has been called an amalgamator. The latter is now a deprecated term. ISO 2018 All rights reserved vBS EN ISO 13897:2018This page deliberately left blankDentistry - Dental amalgam reusable mixing-capsules (ISO 13897:2018)1 ScopeThis document specifies the requirements for reusable m

31、ixing-capsules intended to contain dental amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the test methods used to determine conformity to these requirements.NOTE ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are

32、not dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitute requirements of this document. For dated references only the edition

33、 cited applies. For undated references the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 7488, Dentistry Mixing machines for dental amalgamISO 24234:2015, Dentistry Dental amalgam3 Terms and definitionsFor the purposes of this document

34、, the terms and definitions given in ISO 1942 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at https:/www.iso.org/obp IEC Electropedia: available at http:/www.electropedia.org/3.1de

35、ntal amalgam alloyalloy in fine particles, composed mainly of silver, tin and copper, which when mixed with dental mercury produces a dental amalgamSOURCE: ISO 20749:2017, 3.13.2dental mercurymercury supplied for use in the preparation of dental amalgamSOURCE: ISO 20749:2017, 3.2INTERNATIONAL STANDA

36、RD ISO 13897:2018 ISO 2018 All rights reserved 1BS EN ISO 13897:2018ISO 13897:20184 Requirements4.1 Dimensions4.1.1 Length toleranceThe overall length of the mixing-capsule shall be within 1 mm of the length specified by the manufacturer.Testing shall be carried out in accordance with 6.1.All 10 cap

37、sules in the sample under test shall meet the requirement for length tolerance.4.1.2 Diameter toleranceThe maximum external diameter of the mixing-capsule shall be within 0,5 mm of the diameter specified by the manufacturer.Testing shall be carried out in accordance with 6.1.All 10 capsules in the s

38、ample under test shall meet the requirement for diameter tolerance.4.2 Loss of mass from the mixing-capsule during mixingThe loss in mass from the mixing-capsule during mixing shall not exceed 0,5 mg. Testing shall be carried out in accordance with 6.2.Five out of five, or nine out of 10, mixing-cap

39、sules in the sample under test shall meet the requirement for loss of mass from the mixing-capsule during mixing.4.3 Retention of dental amalgam in the mixing-capsuleThe retention of dental amalgam in the mixing-capsule after the dental amalgam pellet has been removed shall not exceed 1 % of the com

40、bined masses of dental amalgam alloy and dental mercury inserted before mixing.Testing shall be carried out in accordance with 6.3.Five out of five, or nine out of 10, mixing-capsules in the sample under test shall meet the requirement for retention of dental amalgam in the mixing capsule.5 Sampling

41、A number of mixing-capsules sufficient to perform all tests shall be obtained from a single lot produced for retail.6 Measurements and test methods6.1 Dimensions6.1.1 Apparatus6.1.1.1 Micrometer or an optical comparator, having an accuracy and resolution of 0,05 mm.2 ISO 2018 All rights reservedBS E

42、N ISO 13897:2018ISO 13897:20186.1.2 Test sample10 mixing-capsules.6.1.3 ProcedureMeasurements shall be made to an accuracy of 0,05 mm.Measure the overall length of each mixing-capsule.Determine the location of the largest diameter and measure the diameter at this position for each mixing-capsule.Rec

43、ord these values.6.1.4 Report6.1.4.1 GeneralReport the overall length and maximum diameter of all 10 mixing-capsules.6.1.4.2 ConformityReport whether the product does, or does not, conform to the requirements for dimensional tolerances given in 4.1.1 and 4.1.2.6.2 Loss of mass from the mixing-capsul

44、e during mixing6.2.1 PrincipleThe loss of content from the mixing-capsule during mixing is determined by weighing the mixing-capsule initially and again after mixing. Repeating the measurement of loss of mass from the mixing-capsule and testing a number of mixing-capsules are required because the am

45、ount lost could vary from mix to mix and from capsule to capsule.6.2.2 Test sampleSelect five mixing-capsules at random. If the use of a pestle is recommended, select five of a type recommended for use with the mixing-capsule.If one of these mixing-capsules does not satisfy the requirement for the l

46、oss of mass from the mixing-capsule during mixing, a further five mixing-capsules from the same lot will be required.6.2.3 Apparatus6.2.3.1 Laboratory balance, with an accuracy and resolution of 0,1 mg.6.2.3.2 Periodontal probe, WHO type, ball ended (0,5 mm diameter).6.2.3.3 Brush having soft bristl

47、es.6.2.3.4 Mixing machine for dental amalgam, in accordance with ISO 7488.6.2.3.5 Dental amalgam alloy and dental mercury in sachets, in accordance with ISO 24234.6.2.3.6 Surgical gloves, latex or similar. ISO 2018 All rights reserved 3BS EN ISO 13897:2018ISO 13897:20186.2.3.7 Stereomicroscope, 10.6

48、.2.3.8 Tweezers, stainless steel with pointed ends.6.2.3.9 Weighing boats (25).6.2.4 Test procedure6.2.4.1 First measurementAt all times wear the surgical gloves when handling the mixing-capsule, to avoid contaminating the surface.Take the mixing-capsule and blow oil-free compressed air over the sur

49、face to remove any adhering dust. Use the stereomicroscope to inspect the surface of the mixing-capsule for any remaining contaminant. If any is present, remove it with the brush.Using the stereomicroscope, inspect the surface of the mixing-capsule for scratches and blemishes. If any are present, make a note of these.Select the appropriate number of dental mercury sachets to obtain the mass of dental mercury that is recommended for mixing with approximately 600 mg of the dental amalgam alloy, according to the instructions of the ma