1、December 2013 Translation by DIN-Sprachendienst.English price group 19No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I
2、CS 11.060.10!%*N“2074390www.din.deDDIN EN ISO 21563Dentistry Hydrocolloid impression materials (ISO 21563:2013);English version EN ISO 21563:2013,English translation of DIN EN ISO 21563:2013-12Zahnheilkunde Hydrokolloidabformmaterialien (ISO 21563:2013);Englische Fassung EN ISO 21563:2013,Englische
3、bersetzung von DIN EN ISO 21563:2013-12Mdecine bucco-dentaire Produits pour empreintes base dhydrocollodes (ISO 21563:2013);Version anglaise EN ISO 21563:2013,Traduction anglaise de DIN EN ISO 21563:2013-12SupersedesDIN EN 21563:1992-01,DIN EN ISO 1564:1999-03 andDIN EN ISO 13716:2000-11www.beuth.de
4、Document comprises 51 pagesIn case of doubt, the German-language original shall be considered authoritative.11.13 DIN EN ISO 21563:2013-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 21563:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Sec
5、retariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental, Working Committee NA 014-00-22 AA Abformwerkstoffe. The DIN Standards corresponding to the Inter
6、national Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 3696 DIN ISO 3696 ISO 6873 DIN EN ISO 6873 Amendments This standard differs from DIN EN 21563:1992-01, DIN EN ISO 1564:1999-03 and DIN EN ISO 13716:2000-11 as follows: a) the three specific produ
7、ct standards for aqueous elastic dental impression materials (alginate, agar and hydrocolloid) have been combined in one product standard; b) the test methods have been aligned; c) the same tear strength test applies to both the alginate impression materials and those based on agar; d) requirements
8、for marking have been updated. DIN 13945: 1990-11 DIN EN 21563: 1992-01 DIN EN ISO 1564: 1999-03 DIN EN ISO 13716: 2000-11 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 6873, Dentistry Dental gypsum products DIN ISO 3696, Water for analytical laborator
9、y use Specification and test methods Previous editions EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21563 August 2013 ICS 11.060.10 Supersedes EN 21563:1991, EN ISO 13716:2000, EN ISO 1564:1998English Version Dentistry - Hydrocolloid impression materials (ISO 21563:2013) Mdecine bucco-de
10、ntaire - Produits pour empreintes base dhydrocollodes (ISO 21563:2013) Zahnheilkunde - Hydrokolloidabformmaterialien(ISO 21563:2013) This European Standard was approved by CEN on 22 June 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions fo
11、r 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 CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in thre
12、e 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 Centre has the same status as the official versions. CEN members are the national standards bod
13、ies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, S
14、pain, 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-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldw
15、ide for CEN national Members. Ref. No. EN ISO 21563:2013: EContents PageForeword 3Introduction 41 Scope . 52 Normative references 53 Terms and definitions . 54 Classification of agar hydrocolloid impression materials . 75 Requirements Characteristics and properties . 86 Pre-test planning approaches
16、. 96.1 Sampling . 96.2 Pre-test product examinations 96.3 Essential pre-test preparatory practices . 107 Test methods 127.1 Working time test (alginate materials only) . 127.2 Initial setting time test (alginate impression materials only) . 137.3 Detail reproduction test before and after specimen di
17、sinfection 137.4 Compatibility with gypsum test 167.5 Elastic recovery test. 177.6 Strain-in-compression test 207.7 Tear strength test . 217.8 Linear dimensional change test (Type 3A agar materials with companion alginate only) 237.9 Tensile bond strength test (Type 3A agar/companion alginate materi
18、al specimen only) .258 Requirements Labelling and instructions for use .278.1 Labelling 278.2 Requirements Instructions for use 28Annex A (normative) Figures illustrating instruments and accessories used in tests 31Annex B (informative) Tear test specimen preparation steps for an optional gripping m
19、ethod .45Bibliography .49DIN EN ISO 21563:2013-12 EN ISO 21563:2013 (E) 2 Foreword This document (EN ISO 21563:2013) has 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
20、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 standards shall be withdrawn at the latest by February 2014. Attention is drawn to the possibility that some of the elemen
21、ts 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 EN 21563:1991, EN ISO 13716:2000, EN ISO 1564:1998. This first edition of ISO 21563 constitutes a consolidation of the thr
22、ee 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 ISO 13716:1999, Dentistry Reversible/irreversible hydrocolloid impression
23、 materials systems Re-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 materials (ISO 1563) are now required to be subject to the same tear strength
24、 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 materials to be “free from foreign materials”, as stated in ISO 1563, has not bee
25、n 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 forward for the agar impression materials because results of the elastic reco
26、very 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. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the f
27、ollowing countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherland
28、s, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 21563:2013 has been approved by CEN as EN ISO 21563:2013 without any modification. DIN EN ISO 21563:2013-12 EN ISO 21563:2013 (E) 3 IntroductionPart
29、ies 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 inquiry to the national standards body representing the interests
30、 of the inquiring parties.DIN EN ISO 21563:2013-12 EN ISO 21563:2013 (E) 4 1 ScopeThis International Standard specifies the requirements and tests for helping determine whether the elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of th
31、e quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use.NOTE This International Standard specifies no requirements or tests for freedom from unacceptable biological hazards. However, it is recommended that, to address possible biological ha
32、zards associated with the use of hydrocolloid impression materials, interested parties should refer to ISO 7405 and ISO 10993.2 Normative referencesThe following referenced documents are indispensable for application of this document. For dated references, only the edition cited applies. For undated
33、 references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 6873, Dentistry Gypsum productsISO 3696, Water for analytical laboratory use Specification and test methods3 Terms and definitionsFor the purposes of this document, the ter
34、ms and definitions given in ISO 1942 and the following apply.3.1bondingadherence of the reversible and non-reversible impression material components constituting a single impression after each of the separate but interfacing materials has reached the level of elasticity and effective setting require
35、d for successful removal from the mouth3.2bulk containerlabelled consumer packaging or primary packaging container holding a greater amount of otherwise unpackaged granular, liquid, powder, or other loose substance than is usually needed for a single dental clinical or laboratory procedure3.3combine
36、d 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 bond with the non-reversible alginate material that will be forced over it later during the formation of an impression3.4cons
37、umer packagingretail packagingsales packagingpackaging constituting, with its contents, a sales unit to the final user or consumer at the point of retailSOURCE: ISO 21067:2007, definition 2.2.5DIN EN ISO 21563:2013-12 EN ISO 21563:2013 (E) 5 3.5elastic recovery testmethod of determining whether an e
38、lastic impression material will possess the elastic properties required to recover optimally from deformation occurring 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
39、 material is extruded from the containing cartridge or syringe onto any oral cavity tissue3.7impressionnegative copy 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 surfa
40、ces, and allowing it to harden, or to become elastic, such that the entire impression material/tray assembly can be 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) fo
41、rming material poured against the intaglio surface so that, when the modelling material sets, a positive copy of the 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
42、a time when results of a prescribed test show that the activated material has begun to set at a rate indicating that 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 operat
43、ors, users and standards developers because they can be helpful: in determining whether quality of a product has deteriorated 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
44、instructions, it can be assumed that the product is of a quality suitable for testing or use; in the development of 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 su
45、bsequently specified procedure can safely begin.EXAMPLE It is reasonable to expect that the effective setting times 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
46、 agar impression or duplicating material to change it from the elastic gel state to the mouldable or pourable sol state3.10non-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
47、 the mouldable state required for forming impressions3.11primary packagingprimary containerimmediate container (deprecated)packaging designed to be in direct contact with the productNote 1 to entry: Adapted from ISO 21067:2007, definition 2.2.2.DIN EN ISO 21563:2013-12 EN ISO 21563:2013 (E) 6 3.12reversible impression materialimpression material such as an agar hydrocolloid which, after having been brought to the
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