EN ISO 21563-2013 en Dentistry - Hydrocolloid impression materials《牙科学 水胶体印模材料》.pdf

1、BSI Standards PublicationBS EN ISO 21563:2013Dentistry Hydrocolloidimpression materials (ISO21563:2013)BS EN ISO 21563:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 21563:2013. It supersedes BS 4269-2:1991, BS EN ISO 13716:2000 and BS EN ISO 1564:1999

2、 which are withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/2, Prosthodontic materials.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisi

3、ons of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 71399 6 ICS 11.060.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was publish

4、ed under the authority of the Standards Policy and Strategy Committee on 31 August 2013.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21563 August 2013 ICS 11.060.10 Supersedes EN 21563:1991, EN ISO 13716:2000, EN ISO 1564:19

5、98English Version Dentistry - Hydrocolloid impression materials (ISO 21563:2013) Mdecine bucco-dentaire - Produits pour empreintes base dhydrocollodes (ISO 21563:2013) Zahnheilkunde - Hydrokolloidabformmassen (ISO 21563:2013) This European Standard was approved by CEN on 22 June 2013. CEN members ar

6、e 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

7、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 own language and notified to the CEN-CENELEC Management Ce

8、ntre 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, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithua

9、nia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1

10、000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21563:2013: EBS EN ISO 21563:2013EN ISO 21563:2013 (E) 3 Foreword This document (EN ISO 21563:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistr

11、y“ 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 February 2014, and conflicting national

12、standards shall be withdrawn at the latest by February 2014. 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. This document supersedes

13、EN 21563:1991, EN ISO 13716:2000, EN ISO 1564:1998. 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, Finland

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

15、21563:2013 has been approved by CEN as EN ISO 21563:2013 without any modification. BS EN ISO 21563:2013ISO 21563:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification of agar hydrocolloid impressio

16、n materials . 35 Requirements Characteristics and properties . 46 Pre-test planning approaches . 56.1 Sampling . 56.2 Pre-test product examinations 56.3 Essential pre-test preparatory practices 67 Test methods . 87.1 Working time test (alginate materials only) 87.2 Initial setting time test (alginat

17、e impression materials only) 97.3 Detail reproduction test before and after specimen disinfection . 97.4 Compatibility with gypsum test 127.5 Elastic recovery test. 137.6 Strain-in-compression test 167.7 Tear strength test . 177.8 Linear dimensional change test (Type 3A agar materials with companion

18、 alginate only) 197.9 Tensile bond strength test (Type 3A agar/companion alginate material specimen only) .218 Requirements Labelling and instructions for use .238.1 Labelling 238.2 Requirements Instructions for use 24Annex A (normative) Figures illustrating instruments and accessories used in tests

19、 27Annex B (informative) Tear test specimen preparation steps for an optional gripping method .41Bibliography .45BS EN ISO 21563:2013ISO 21563:2013(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work

20、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-government

21、al, 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.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main

22、task of technical committees is to prepare International Standards. Draft International Standards adopted 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.Attent

23、ion is drawn to the possibility 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.ISO 21563 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materi

24、als.This first edition of ISO 21563 constitutes a consolidation of the three standards listed below and, as such, cancels and replaces, in whole, all three of the standards listed. ISO 1563:1990, Dentistry Alginate impression materials ISO 1564:1995, Dental aqueous impression materials based on agar

25、 ISO 13716:1999, Dentistry Reversible/irreversible hydrocolloid impression materials systemsRe-evaluations of all the provisions stated in the three ISO standards to be included in the consolidation led to the significant technical changes listed as follows. The alginate hydrocolloid impression mate

26、rials (ISO 1563) are now required to be subject to the same tear strength test that has been in effect for the agar hydrocolloid impression materials (ISO 1564 and ISO 13716) instead of being subject to a compressive strength test. The requirement for the alginate impression material powder material

27、s to be “free from foreign materials”, as stated in ISO 1563, has not been carried forward into the consolidation because no objective test has been specified for determining compliance with the requirement. The “gelation temperature” requirements in ISO 1564 and ISO 13716 have not been carried forw

28、ard for the agar impression materials because results of the elastic recovery test (7.5), if conducted following the required manufacturers instructions for use (8.2.1 and/or 8.2.2), will indicate whether adequate gelation will take place during clinical use of the materials.iv ISO 2013 All rights r

29、eservedBS EN ISO 21563:2013ISO 21563:2013(E)IntroductionParties seeking clarification of any provisions of this International Standard, or desiring to recommend improvements for the next edition, are encouraged to do so by contacting ISO/TC 106, Dentistry, whose address can be obtained through inqui

30、ry to the national standards body representing the interests of the inquiring parties. ISO 2013 All rights reserved vBS EN ISO 21563:2013BS EN ISO 21563:2013Dentistry Hydrocolloid impression materials1 ScopeThis International Standard specifies the requirements and tests for helping determine whethe

31、r the elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use.NOTE This International Standard specifies no requirements

32、or tests for freedom from unacceptable biological hazards. However, it is recommended that, to address possible biological hazards associated with the use of hydrocolloid impression materials, interested parties should refer to ISO 7405 and ISO 10993.2 Normative referencesThe following referenced do

33、cuments are indispensable for 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 VocabularyISO 6873, Dentistry Gypsum productsISO 3696, Water

34、for analytical laboratory use Specification and test methods3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1bondingadherence of the reversible and non-reversible impression material components constituting a single impr

35、ession after each of the separate but interfacing materials has reached the level of elasticity and effective setting required for successful removal from the mouth3.2bulk containerlabelled consumer packaging or primary packaging container holding a greater amount of otherwise unpackaged granular, l

36、iquid, powder, or other loose substance than is usually needed for a single dental clinical or laboratory procedure3.3combined reversible/non-reversible impression material systemsystem of impression making in which a light bodied agar material is first syringed around selected teeth so that it can

37、bond with the non-reversible alginate material that will be forced over it later during the formation of an impression3.4consumer packagingretail packagingsales packagingpackaging constituting, with its contents, a sales unit to the final user or consumer at the point of retailSOURCE: ISO 21067:2007

38、, definition 2.2.5INTERNATIONAL STANDARD ISO 21563:2013(E) ISO 2013 All rights reserved 1BS EN ISO 21563:2013ISO 21563:2013(E)3.5elastic recovery testmethod of determining whether an elastic impression material will possess the elastic properties required to recover optimally from deformation occurr

39、ing during removal of impressions from contact with the impressed oral or craniofacial tissues3.6extrusion temperaturetemperature at which a liquefied Type 3 or Type 3A agar impression material is extruded from the containing cartridge or syringe onto any oral cavity tissue3.7impressionnegative copy

40、 of oral or craniofacial tissue surfaces obtained by impressing a mouldable impression material, usually contained in an impression tray, or injected into contact with the tissue surfaces, and allowing it to harden, or to become elastic, such that the entire impression material/tray assembly can be

41、removed from the contact without significant harm to the tissues or to the assemblyNote 1 to entry: A properly formed impression is capable of having a relatively fluid model (cast) forming material poured against the intaglio surface so that, when the modelling material sets, a positive copy of the

42、 impressed surfaces is formed.3.8initial setting timetime, measured from commencement of mixing components of a material, or otherwise activating the chemistry involved, and ending at a time when results of a prescribed test show that the activated material has begun to set at a rate indicating that

43、 the effective setting time will be reached at some predictable time thereafterNote 1 to entry: Initial setting times stated in the manufacturers instructions are useful to test operators, users and standards developers because they can be helpful: in determining whether quality of a product has det

44、eriorated before or after opening of the packaging; for example, if the initial setting time found by the test operator or user corresponds closely to that stated in the manufacturers instructions, it can be assumed that the product is of a quality suitable for testing or use; in the development of

45、standards for certain materials when there is a need for a standard to identify a reference point in time that can be used as a basis for specifying a later point in time at which a subsequently specified procedure can safely begin.EXAMPLE It is reasonable to expect that the effective setting times

46、for certain types of gypsum product mixtures will have been reached within 45 min after the initial setting times previously recorded for the mixes.3.9liquefactionprocess of heating an agar impression or duplicating material to change it from the elastic gel state to the mouldable or pourable sol st

47、ate3.10non-reversible impression materialany impression material which, having been brought to the effective setting stage as required for removal from the mouth, cannot be returned to the mouldable state required for forming impressions3.11primary packagingprimary containerimmediate container (depr

48、ecated)packaging designed to be in direct contact with the productNote 1 to entry: Adapted from ISO 21067:2007, definition 2.2.2.2 ISO 2013 All rights reservedBS EN ISO 21563:2013ISO 21563:2013(E)3.12reversible impression materialimpression material such as an agar hydrocolloid which, after having b

49、een brought to the gel state for marketing purposes, can be heated so as to bring it to the relatively fluid colloid or paste-like state required for making an impressionNote 1 to entry: Whereas in past years the “gel to sol” and “sol to gel” reversibility capacities of such impression materials has allowed them to be recycled for repeated uses, modern infection control practices now discourage user recycling of the reversible impression materials for repeated uses in the mouth.3.13secondary packagingover packaging (deprecated)