SIST EN ISO 13716:2001
(Main)Dentistry - Reversible-irreversible hydrocolloid impression material systems (ISO 13716:1999)
Dentistry - Reversible-irreversible hydrocolloid impression material systems (ISO 13716:1999)
Zahnheilkunde - Reversible-irreversible Hydrokolloid-Abformmaterialiensysteme (ISO 13716:1999)
In dieser Internationalen Norm werden Anforderungen und Prüfmethoden zur Bestimmung der Zug-und Haftfestigkeit und der linearen Größenänderung reversibler-irreversibler Hydrokolloid-Abformmaterialien in der Zahnheilkunde sowie Anforderungen zur Etikettierung und an die Gebrauchsanweisung des Herstellers festgelegt. Diese Internationale Norm gilt für dentale Alginat- und für spritzbare Agar-Abformmaterialien, die so in der Mischung angesetzt werden, dass sie sich bei kombinierter Anwendung in einer Weise verbinden,
dass elastische Abformungen des Gewebes in der Mundhöhle durchgeführt werden können. ANMERKUNG Anforderungen für weitere Merkmale und Eigenschaften dieser Abformmaterialien sind in ISO 1563 und ISO 1564 festgelegt.
Art dentaire - Systemes de produits pour empreintes a base d'hydrocolloides réversibles-irréversibles (ISO 13716:1999)
La présente Norme internationale spécifie les exigences et les méthodes d'essai relatives aux contraintes d'adhérence en traction et aux variations dimensionnelles linéaires des systèmes de produits pour empreintes à base d'hydrocolloïdes réversibles-irréversibles utilisés en art dentaire, ainsi que les exigences concernant leur étiquetage et les instructions du fabricant. La présente Norme internationale s'applique aux produits pour empreintes à base d'alginate et à ceux à base d'agar-agar que l'on peut appliquer à l'aide d'une seringue, et qui ont été formulés de manière à ce qu'ils adhèrent l'un à l'autre quand on les utilise ensemble pour obtenir des empreintes élastiques des tissus de la cavité buccale. NOTE: Les exigences relatives aux autres caractéristiques et propriétés de ces produits pour empreintes sont spécifiées dans l'ISO 1563 et l'ISO 1564.
Dentistry - Reversible-irreversible hydrocolloid impression material systems (ISO 13716:1999)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 13716:2001
01-november-2001
Dentistry - Reversible-irreversible hydrocolloid impression material systems (ISO
13716:1999)
Dentistry - Reversible-irreversible hydrocolloid impression material systems (ISO
13716:1999)
Zahnheilkunde - Reversible-irreversible Hydrokolloid-Abformmaterialiensysteme (ISO
13716:1999)
Art dentaire - Systemes de produits pour empreintes a base d'hydrocolloides réversibles-
irréversibles (ISO 13716:1999)
Ta slovenski standard je istoveten z: EN ISO 13716:2000
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 13716:2001 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 13716:2001
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SIST EN ISO 13716:2001
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SIST EN ISO 13716:2001
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SIST EN ISO 13716:2001
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SIST EN ISO 13716:2001
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SIST EN ISO 13716:2001
INTERNATIONAL ISO
STANDARD 13716
First edition
1999-05-01
Dentistry — Reversible-irreversible
hydrocolloid impression material systems
Art dentaire — Systèmes de produits pour empreintes à base
d'hydrocolloïdes réversibles-irréversibles
A
Reference number
ISO 13716:1999(E)
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SIST EN ISO 13716:2001
ISO 13716:1999(E)
Contents
Page
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Requirements.2
5 Sampling.2
6 Test methods — General .2
7 Tensile bond strength test.3
8 Linear dimensional change test .5
9 Information required in manufacturer’s instructions.7
10 Requirements for labelling .8
Bibliography.15
© ISO 1999
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 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
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SIST EN ISO 13716:2001
© ISO
ISO 13716:1999(E)
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
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 13716 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee
SC 2, Prosthodontic materials.
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SIST EN ISO 13716:2001
© ISO
ISO 13716:1999(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this ISO
Standard. But it is recommended that, in assessing possible biological or toxicological hazards, reference be made
to ISO 7405 and ISO 10993-1.
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SIST EN ISO 13716:2001
INTERNATIONAL STANDARD © ISO ISO 13716:1999(E)
Dentistry — Reversible-irreversible hydrocolloid impression
material systems
1 Scope
This international Standard specifies requirements and test methods for tensile bond strength and linear
dimensional change of reversible-irreversible hydrocolloid impression materials used in dentistry, as well as
requirements for their labelling and manufacturer's instructions.
This International Standard is applicable to those alginate and syringeable agar dental impression materials which
have been formulated such that they will bond to each other, when used in combination, to provide elastic
impressions of oral tissues.
NOTE Requirements for other characteristics and properties of these impression materials are given in ISO 1563 and
ISO 1564.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 1563:1990, Dental alginate impression material.
ISO 1564:1995, Dental aqueous impression materials based on agar.
ISO 1942 (all parts), Dental vocabulary.
3 Terms and definitions
For purposes of this International Standard, the terms and definitions given in ISO 1942 and the following apply.
3.1
bond
Æbetween dental reversible and irreversible impression materialsæ adherence of the materials to each other after
both materials have set
3.2
storing
Æof agar impression materialæ conditioning of the material, immediately after liquefaction, to reduce and maintain the
temperature required for use in a succeeding step
3.3
tensile bond strength
Æof reversible-irreversible impression material specimenæ force per unit area required to create a rupture in a
specimen tested in the tensile mode
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SIST EN ISO 13716:2001
© ISO
ISO 13716:1999(E)
4 Requirements
4.1 Biocompatibility
See Introduction.
4.2 Requirements given in ISO 1563 and ISO 1564 for characteristics and properties
When a manufacturer identifies any alginate material as being acceptable for use in combination with a particular
agar material, each alginate material so identified shall be subject to all applicable requirements and tests stated in
this International Standard and in ISO 1563 for alginate materials. Likewise, any agar material identified for use with
a particular alginate material shall be subject to all applicable requirements and tests stated in this International
Standard and to those in ISO 1564, except for the gelation temperature requirement (see clause 2).
4.3 Requirements given in this International Standard for characteristics and properties
4.3.1 Tensile bond strength
When tested in accordance with clause 7, the tensile bond strength between the agar and alginate shall not be less
than 50 kPa.
4.3.2 Linear dimensional change
When tested in accordance with clause 8, the negative dimensional change of the combined impression material
system specimens shall not be more than 1,0 % when measured at 20 min after commencement of mixing of the
alginate component.
4.4 Requirements for instructions for use, packaging and labelling
The materials shall be subject to applicable requirements specified in clauses 9 and 10 of this International
Standard and to requirements specified for instructions, packaging and labelling in pertinent clauses of ISO 1563
and ISO 1564.
5 Sampling
Samples shall be procured from a single manufacturing batch as packaged for retail marketing, to include the
manufacturer’s instructions.
6 Test methods — General
6.1 Laboratory conditions
Unless otherwise specified in this International Standard, conduct all specimen preparation and testing under
ambient laboratory conditions of (23 – 2) °C and (50 – 10) % relative humidity. Unless otherwise specified in this
International Standard, bring all equipment and materials used in the tests to ambient temperature before beginning
specimen preparation and testing.
6.2 Apparatus function verification
Before using any accessories, instruments or other items of equipment, calibrate or otherwise determine whether
they comply with specifications given in this International Standard or in a related supporting standard.
6.3 Material manipulation and specimen preparation
Unless otherwise specified in this International Standard, prepare and manipulate the materials used for forming the
test specimens using the equipment and procedures recommended in the manufacturer’s instructions (see clause 9
of this International Standard and corresponding pertinent clauses in ISO 1563 and ISO 1564).
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SIST EN ISO 13716:2001
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ISO 13716:1999(E)
Prepare a mix consisting of 15 g of alginate powder with the specified amount of distilled or deionized water for
making each tensile bond strength and linear dimensional change test specimen.
One stick (approximately 2,5 ml to 3,5 ml) of the agar material is needed for each specimen.
6.4 Pass/fail determinations
Prepare a series of five specimens initially for each of the tests. If four of the five 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 tested in the two series
comply, the material passes; otherwise the material fails.
6.5 Expression of test results
Report the number of specimens tested, the number of specimens complying with the specified requirement, and
whether the material passes or fails.
6.6 Pass/fail determinations and expression of results for tests specified in ISO 1563 and
ISO 1564
Use criteria specified in ISO 1563 and ISO 1564.
7 Tensile bond strength test
7.1 Apparatus
7.1.1 Apparatus for preparing the agar
7.1.1.1 Two water baths, one for liquefying the agar and one for storing the liquefied material.
7.1.1.2 Temperature-measuring device, such as 76 mm immersion calibrated thermometer having graduations
of 0,1 °C.
7.1.1.3 Syringes and needles, for use in dispensing the agar in clinical use, and wire probes for cleaning syringe
needle barrels. The inside diameters of the syringe needles shall be the same as those recommended by the
manufacturer for making crown and fixed partial denture impressions [9.2.1 a)].
Before using the syringes, verify their ability to prevent aspiration of water during the storing cycle.
7.1.2 Apparatus for preparing the alginate
7.1.2.1 Container, capable of being sealed, for storage of the alginate to protect it from moisture contamination
after initial opening of the package.
7.1.2.2 Weighing boat.
7.1.2.3 Balance, accurate to 0,1 g.
7.1.2.4 Scoop for removing alginate powder from the container.
7.1.2.5 Graduated cylinder or syringe for measuring water.
7.1.2.6 Distilled or deionized water, at the temperature required for mixing the alginate according to the
manufacturer’s instructions.
7.1.2.7 Temperature-measuring device (7.1.1.2) for measuring water temperature.
7.1.2.8 Mixing equipment or utensils recommended by the manufacturer. When hand mixing is recommended,
the bowl shall have a depth of approximately 90 mm and an opening of approximately 120 mm in diameter.
7.1.2.9 Timing device, such as a stopwatch.
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SIST EN ISO 13716:2001
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ISO 13716:1999(E)
7.1.3 Apparatus for forming and testing specimens
7.1.3.1 Mated set(s) of specimen-forming component halves (Figure 1) with each mated set marked to indicate
which half is to be designated as the top and which is to be the bottom. The bottom half for each mated set shall be
the half for which the lesser orifice diameter has been recorded. The recorded diameter for the orifice of each half
shall be determined by calculating the average of two internal diameter measurements, made at right angles to
each other, for each orifice.
7.1.3.2 Tubular support for the top specimen-forming half (Figure 3).
7.1.3.3 Metal or plastic disc, approximately (25 – 0,5) mm in diameter and (1,30 – 0,5) mm thick, to be used for
shaping the alginate cavity into which the agar will be injected.
7.1.3.4 V-trough (Figure 2 and Figure 3).
7.1.3.5 Weight (Figure 3).
7.1.3.6 Humidor, capable of maintaining a temperature of (35 – 1) °C and (95 – 5) % relative humidity, to simulate
the temperature and humidity of the oral environment.
7.1.3.7 Tensile-testing instrument, capable of applying a test load at a rate of 500 mm/min and accurate to 1 N.
7.2 Advance preparation steps
Use the temperature-measuring device (7.1.1.2) to verify the temperature of
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