EN ISO 1564:1998
(Main)Dental aqueous impression materials based on agar (ISO 1564:1995)
Dental aqueous impression materials based on agar (ISO 1564:1995)
Specifies requirements for physical properties and other characteristics of impression materials and tests for determining compliance with those requirements. It also specifies requirements with respect to the manufacturer's instructions, and the essentials for packaging, labelling and marking. Replaces the first edition to which a great number of amendments were made.
Dentale Abformmassen auf Agarbasis (ISO 1564:1995)
Diese Internationalen Norm legt Anforderungen für wesentliche physikalische Eigenschaften und andere Merkmale von Abformmassen, die reversibles Agar-Hydrokolloid als gelbildenden Bestandteil enthalten, zusammen mit Prüfungen fest, um die Übereinstimmung mit diesen Anforderungen zu ermitteln. Sie legt auch Anforderungen in Bezug auf die Herstellerangaben fest und das Wesentliche für Verpackung, Beschriftung und Kennzeichnung.
Produits dentaires hydrauliques pour empreintes à base d'agar-agar (ISO 1564:1995)
Dental aqueous impression materials based on agar (ISO 1564:1995)
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dental aqueous impression materials based on agar (ISO 1564:1995)Dentale Abformmassen auf Agarbasis (ISO 1564:1995)Produits dentaires hydrauliques pour empreintes a base d'agar-agar (ISO 1564:1995)Dental aqueous impression materials based on agar (ISO 1564:1995)11.060.10Dental materialsICS:Ta slovenski standard je istoveten z:EN ISO 1564:1998SIST EN ISO 1564:2000en01-januar-2000SIST EN ISO 1564:2000SLOVENSKI
STANDARD
INTERNATIONAL STANDARD Iso 1564 Second edition 1995-I I-01 Dental aqueous impression materials based on agar Produits dentaires hydrauliques pour empreintes à base d ‘agar-agar Reference number ISO 1564:1995(E) SIST EN ISO 1564:2000
ISO 1564:1995(E) Contents Page 1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~. 1 3 Def initions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~. 1 4 Classification by type . 1 5 Requirements for characteristics and physical properties . 1 5.1 Biocompatibility . 1 5.2 Homogeneity (Sol state) . 2 5.3 Consistency: types 1 and 2 (Sol state) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5.4 Extrudability: types 2 and 3 (Sol state) . 2 6 Sampling . 2 7 Test methods: basic conditions and procedures . 2 7.1 Specimen preparation . 2 7.2 Test conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 7.3 Number of specimens to be tested for pass/fail determinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 7.4 Expression of results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 8 Test procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 8.1 Homogeneity: type 1 only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 8.2 Consistency: types 1 and 2 . . 3 8.3 Extrudability: types 2 and 3 . 3 8.4 Extrusion temperature: types 2 and 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 8.5 Gelation temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 8.6 Detail reproduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 8.7 Compatibility with gypsum . 6 8.8 Recovery from deformation . 8 0 ISO 1995 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case Postale 56 l CH-1 211 Genève 20 l Switzerland Printed in Switzerland ii SIST EN ISO 1564:2000
0 KO ISO 1564:1995(E) 8.9 Strain in compression . 10 8.10 Resistance to tearing . 11 9 Required instructions for use . 13 10 Requirements for packaging and marking . 14 10.1 Packaging . 14 10.2 Labelling and marking . 14 . . . III SIST EN ISO 1564:2000
ISO 1564:1995(E) 0 ISO Foreword 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 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-governmental, 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. 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. International Standard ISO 1564 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. This second edition cancels and replaces the first edition (ISO 1564:1976) to which the following changes were made: - The materials are now classified according to consistencies and pur- poses. - The requirement for odour and flavour has been deleted due to lack of an appropriate test. However, it is recognized that the impression material, when handled in accordance with the manufacturer3 in- structions should have no unpleasant odour or flavour attributable to spoilage or contamination. - A requirement and an accompanying test for tear resistance replaces the test for compressive strength because the tear test has been judged to be more significant to clinical performance of the agar ma- terials, especially in relation to impressions for fixed prosthodontics. - Requirements and tests for consistency and extrusion temperatures have been added. - Designs for the apparatus used in the detail reproduction, compatibility with gypsum, recovery from deformation (permanent deformation), and strain-in-compression tests have been improved in the interest of ob- taining more objective test results and to make the tests easier to conduct. - A requirement relative to antimicrobial characteristics has been added. - A requirement for manufacturers to identify gypsum products which have been found to be compatible with their impression materials has been added. iv SIST EN ISO 1564:2000
63 ISO ISO 1564:1995(E) - The previous edition specified that most of the pass/faiI determinations made for the materials being tested were to be based on averaged values calculated for two or more specimens. Pass/fail determinations made in accordance with this edition are based on the concept that results for each specimen should be compared with the specified per- formance limit in a separate pass/faiI exercise. V SIST EN ISO 1564:2000
Page blanche SIST EN ISO 1564:2000
INTERNATIONAL STANDARD 0 ISO ISO 1564:1995(E) Dental aqueous impression materials based on agar 1 Scope This International Standard specifies requirements for essential physical properties and other characteristics of impression materials having reversible agar hydrocolloid as a gel-forming ingredient, along with tests specified for determining compliance with those requirements. It also specifies requirements with re- spect to the manufacturer’s instructions, and the es- sentials for packaging, labelling and marking. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publi- cation, the editions indicated were valid. AII standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most re- cent editions of the standards indicated below. Members of IEC and ISO maintain registers of cur- rently valid International Standards. 3.2 immediate container: Container which is in di- rect contact with the impression material. 3.3 storing: Conditioning of the material, immedi- ately after liquefication, needed to reduce the tem- perature as required prior to its use in syringing, or prior to tempering. 3.4 tempering: Conditioning of the material, after the storing treatment, needed to reduce the tem- perature of the material as required prior to its in- sertion into the mouth. 4 Classification by type Type 1 - High consistency: For making im- pressions of complete or partial dental arches, with or without the use of syringe-extruded increments of type 2 or type 3 materials. Type 2 - Medium consistency: For making im- pressions of complete and partial dental arches, with or without the use of syringe-extruded increments, and also for use as a syringe-extruded material. Type 3 - Low consistency: For syringe use only. ISO 6873: 1983, Dental gypsum products. lSO/TR 7405: 1984, Biological evaluation of dental ma terials. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 gelation temperature: Temperature at which the agar impression material develops the elastic properties which Will permit removal of an impression from undercuts in the mouth with only minimal dis- tortion. 5 Requirements for characteristics and physical properties The requirements are given in table 1. 5.1 Biocompatibility Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this International Standard, but it is recommended that reference be made to ISO/TR 7405 when as- sessing possible biological or toxicological hazards associated with infection or irritation of normal oral mucosa, or with the concentration of potentially toxic elements or components. 1 SIST EN ISO 1564:2000
ISO 1564:1995(E) 0 ISO Table 1 - Required property value limits 8.4 8.5 8.6 8.7 8.8 8.9 8.10 Extrusion Gelation Detail Compatibility Recovery Strain in Resistance TYPe temperature temperature reproduction with gypsum from deformation compression to tearing “C “C % % N/mm min. max.‘) min. max. min. min. max. min. Type 1 - - 37 45 0,02 0,05 96.5 4 15 0,75 2) Type 2 45 52 37 45 0,02 0,05 96.5 4 15 0,75 2) Type 3 45 52 37 45 0,02 0,05 96.5 4 15 0 5 2) I 1) Maximum temperature the syringed material Will transmit to the teeth as stated by the manufacturer [see clause 9f)] and the maximum temperature that Will be registered as the material is extruded to caver the thermometer bulb during the test. 2) These minimum values apply unless a manufacturer claims a higher value, in which case the test result shall not be less than that stated by the manufacturer. 5.2 Homogeneity (Sol state) When evaluated in accordance with 8.1 and 8.3, the materials shall be free of foreign matter, lumps and granules, and shall exhibit no seiaration of ingrédients that cari be observed during extrusion of the materials from their containers or syringes. 7 Test methods: basic conditions and procedures 7.1 Specimen preparation 5.3 Consistency: types 1 and 2 (Sol state) When tested in accordance with 8.2, the prepared material shall be capable of being extruded from its immediate container into the specified tray within 30 s. 5.4 Extrudability: types 2 and 3 (Sol state) When tested in accordance with 8.2, the prepared material shall be of a consistency that Will permit the entire increment prepared for syringing to be extruded within 30 s. 6 Sampling The sample shall be at least 1 500 g of the impression material taken from a single manufacturing batch, along with any devices or accessories specified in the manufacturer’s instructions for use with the material. The method of procurement shall be subject to agreements between interested parties. 7.1.1 Unless otherwise specified, the materials used for the test specimens shall be prepared and ma- nipulated using the equipment recommended in the manufacturer’s instructions (see clause 9). 7.1.2 The materials used for making the test speci- mens shall be exposed to only one liquefication treatment and the storage time before specimens are made shall not exceed 1 h. 7.1.3 In instances where the amount of material furnished in a single immediate container, or as a type 3 stick, is less than that needed to form a specimen, it Will be necessary to Iiquefy, store and temper the material in a large single container, such as a modified plastic syringe, which Will accommodate the required amount with no risk of dilution. 7.1.4 Gypsum products required for making speci- mens according to this International Standard shall be evaluated for compliance with the initial setting time test specified in ISO 6873 before use in the tests. After the initial opening of their immediate containers and between openings required thereafter, the gypsum materials shall be stored such that they will not be exposed to moisture contamination. 2 SIST EN ISO 1564:2000
0 ISO ISO 1564:1995(E) 7.2 Test conditions AH specimen preparation and physical property tests shall be conducted under uniform atmospheric con- ditions of (23 + 2) “C and (50 + 10) % relative hu- - - midity. Unless otherwise specified in this International Standard, all equipment and materials shall be brought to the uniform condition before beginning specimen preparation or testing. 7.3 Number of specimens to be tested for pass/fail determinations Unless otherwise specified in this International Stan- dard, the number of specimens required is as follows. Test a series of five specimens initially. If four of the specimens comply with the specified requirement, the material passes. If only one or two specimens comply, the material fails. If only three specimens comply, test an additional series of five specimens. If eight of the ten specimens (80 %) tested in the two series comply, the material passes. 7.4 Expression of results Unless otherwise specified in this International Stan- dard, results for the tests shall be reported as follows. Report the number of specimens tested, the number of specimens complying with the specified require- ment and whether the material passes or fails. 8 Test procedures 8.1 Homogeneity: type 1 only NOTE 1 The extrudability test
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