EN ISO 3336:1996
(Main)Dentistry - Synthetic polymer teeth (ISO 3336:1993)
Dentistry - Synthetic polymer teeth (ISO 3336:1993)
Defines an installed monitor for the control and detection of radioactivity of gamma emitters contained in recyclable or non-recyclable materials transported by vehicle, the conceptual requirements, general characteristics, mechanical characteristics, environmental conditions, minimal requirements, test procedures and documentation.
Zahnheilkunde - Kunststoffzähne (ISO 3336:1993)
Diese Internationale Norm legt Einteilung, Anforderungen und Prüfmethoden für Zähne, die aus Kunststoffen wie Polymethylmethacrylat und seinen Co-polymeren zusammengesetzt sind und die für die Anwendung in der zahnärztlichen Prothetik hergestellt werden, fest. Die verwendeten Begriffe stimmen mit den Definitionen in ISO 1942-1 und ISO 1942-2 überein.
Produits et matériel pour l'art dentaire - Dents en polymères synthétiques (ISO 3336:1993)
Définit un moniteur fixe pour le contrôle et la détection de radioactivité d'émetteurs gamma contenus dans des matériaux recyclables ou non recyclables transportés dans des véhicules, les exigences conceptuelles, les caractéristiques générales, les caractéristiques mécaniques, les conditions environnementales, les exigences minimales, les procédures d'essai, et la documentation.
Dentistry - Synthetic polymer teeth (ISO 3336:1993)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 3336:2000
01-januar-2000
Dentistry - Synthetic polymer teeth (ISO 3336:1993)
Dentistry - Synthetic polymer teeth (ISO 3336:1993)
Zahnheilkunde - Kunststoffzähne (ISO 3336:1993)
Produits et matériel pour l'art dentaire - Dents en polymeres synthétiques (ISO
3336:1993)
Ta slovenski standard je istoveten z: EN ISO 3336:1996
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 3336:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 3336:2000
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SIST EN ISO 3336:2000
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SIST EN ISO 3336:2000
INTERNATIONAL
ISO
STANDARD
3336
Second edition
1993-08-15
Dentistry - Synthetic polymer teeth
Produits et matbiel pour /‘art den taire - Den ts en polymeres
syn th6 tiques
Reference number
ISO 3336:1993(E)
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SIST EN ISO 3336:2000
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. Esch 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
(1 EC) 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 3336 was prepared by Technical Committee
lSO/TC 106, Dentistry, Sub-Committee SC 2, Prosthodontic materials.
This second edition cancels and replaces the first edition (ISO 3336:1977).
The main changes are as follows:
revision, in accordance with ISO 7491:1985, of the procedure for the
a)
determination of colour stability;
inclusion of a requirement for manufacturers to provide guidance when
b)
special treatment is required in Order to achieve adequate bonding of
the teeth to denture-base polymers;
inclusion of a requirement for manufacturers to provide details of the
d
dimensions of the teeth, especially the width, in Order to facilitate the
selection of teeth by clinicians;
the hardness test for teeth has been omitted, as the crazing test (6.8)
d)
serves to identify inadequate crosslinking of the polymer.
lt is proposed that at the next revision changes in the procedure in 6.6 for
the determination of the quality of bonding will be considered.
0 ISO 1993
All rights reserved. No part of this publication may be reproduced or utilized in any form or
by any means, electronie or mechanical, including photocopying and microfilm, without per-
mission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-l 211 Geneve 20 l Switzerland
Printed in Switzerland
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SIST EN ISO 3336:2000
ISO 3336:1993(E)
Introduction
Specific qualitative and quantitative requirements of freedom from bio-
logical hazard are not included in this International Standard, but it is rec-
ommended that, in assessing possible biological or toxicological hazards,
reference should be made to ISO 10993-1:1992, Biological evaluation of
medical devices - Part 1: Guidance on selection of tests and
ISO/rR 7405:1984, Biological evaluation of dental materials, or any more
recent editions.
. . .
Ill
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SIST EN ISO 3336:2000
INTERNATIONAL STANDARD ISO 3336:1993(E)
Dentistry - Synthetic polymer teeth
ISO 7491: 1985, Dental ma terials - Determination of
1 Scope
colour s tability of dental polymeric ma terials.
This International Standard specifies a classification,
requirements and test methods for teeth which are
3 Classification
composed of synthetic polymers such as poly(methyl
methacrylate) and its copolymers, and which are
Synthetic polymer teeth are grouped in accordance
manufactured for use in prostheses used in dentistry.
with the following classification.
Terms used are in accordance with the definitions in
- Type 1: anterior teeth
ISO 1942-1 and ISO 1942-2.
- Type 2: posterior teeth
4 Requirements
2 Normative references
The following Standards contain provisions which,
4.1 Dimensions of teeth
through reference in this text, constitute provisions
of this International Standard. At the time of publi-
When measured in accordance with 6.2, the dimen-
cation, the editions indicated were valid. All Standards
sions shall be within 5 % of those stated by the
are subject to revision, and Parties to agreements
manufacturer (see 7.3).
based on this International Standard are encouraged
to investigate the possibility of applying the most re-
4.2 Colour and blend
cent editions of the Standards indicated below.
Members of IEC and ISO maintain registers of cur-
Sets of anterior and posterior teeth, representing each
rently valid International Standards.
shade from the same manufacturer, shall exhibit no
perceptible colour differente between each other and
ISO 483: 1988, Plastics - Small enclosures for con-
the manufacturer’s shade guide (7.2.1), when tested
ditioning and testing using aqueous solutions to
in accordance with 6.3.
main tain relative humidity at constan t value.
ISO 1567:1988, Dentistry - Denture base polymers.
4.3 Freedom from biological hazard
ISO 1942-1 :1989, Dental vocabulary - Part 1: Gen-
See the Introduction for guidance on biological hazard.
eral and clinical terms.
4.4 Freedom from porosity and other
ISO 1942-2: 1989, Dental vocabulary - Part 2: Dental
ma terials. def ects
ISO 3950:1984, Dentistry - Designation System for When examined in accordance with 6.4 (but see
teeth and areas of the oral cavity. 7.2.3), the teeth shall exhibit no porosity or defect,
such as rough trimming and rough finish, on the
ISO 6873: 1983, Dental gypsum products. coronal surfaces.
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SIST EN ISO 3336:2000
ISO 3336:1993(E)
4.5 Surface finish The shade guide, mould Chart and instructions (see
7.2 to 7.4) are required.
4.5.1 Retention of finish
6 Test methods
After processing and reprocessing, the teeth shall be
capable of being polished in accordance with 6.5 to
6.1 General conditions and specimen
restore the original finish.
preparation procedures
4.5.2 Repolishing
6.1 .l Ambient conditions
The teeth shall be capable of being ground and repol-
The teeth and other required materials and equipment
ished to a finish that is equivalent to their original ap-
shall be kept conditioned at (23 & 2) “C and at a rela-
pearance, using
the dental polishing methods
tive humidity of (50 + 10) %, except as otherwise
specified in 6.5.
required in 6.5.2, 6.6.2T6.7.2, 6.8.3 and 6.9.2.
4.6 Quality of bonding to denture-base
6.1.2 Specimen preparation procedures
polymers
Conduct Overall width measurements of dimensions
The teeth shall be capable of being bonded to heat-
Z,, 5, I, and Z, (see figure 1) and prepare the teeth for
polymerized denture-base materials (type 1) which
testing as follows. Remove the teeth from the mount,
conform to ISO 1567. For five out of the six test
flush the wax from the teeth with boiling tap-water
specimens, the bond formed between the ridge lap
containing a detergent and rinse with boiling tap-
Portion of the teeth and the denture-base polymer
water.
shall pass the test described in 6.5.
When the manufacturer of the teeth recommends
6.2 Inspection and conformity to mould
special treatments to achieve adequate bonding, the
Chart
treatments shall be noted in the instructions (7.4).
6.2.4 Apparatus
4.7 Colour stability
6.2.1.1 Micrometer or dial calliper accurate to
There shall be no perceptible colour Change in the
0,Ol mm and fitted with parallel anvils.
exposed tooth when tested in accorda nee with 6.7.
6.2.2 Procedure
4.8 Resistance to blanching, distortion and
crazing
Inspect each set of teeth, cleaned according to 6.1.2,
and report whether
When tested in accordance with 6.8, no tooth shall
exhibit blanching or distortion. Four of five test teeth
a) they are type I or type II;
shall not exhibit crazing with the sole exception of the
ridge lap surfaces. The remaining tooth shall exhibit
b) their shapes are in conformity with the mould
no more than very slight crazing, Seen only with diffi- Chart (7.3);
culty.
c) their colour and blend is consistent within the set
(4.2 and 7.2); and
4.9 Dimensional stability
d) their surface finish and packaging conforms with
When tested in accordance with 6.9, the dimensional
the requirements of 4.5 and 7.1.
Change of a tooth shall be within ~t: 2 % of its original
mesio-distal dimension.
With reference to figure 1, and using a micrometer
(6.2.1), measure the maximum dimension of each
5 Test Sample maxillary and mandibular set of anterior teeth (/, and
5) in the in-line plane, for conformity to the mould
The Sample consists of five groups, each comprising Chart dimensions (4.1). Measure the maximum di-
sets of maxillary and mandibular anterior and posterior mensions (1,,
h, and 14, h2) of the maxillary and
teeth (28 teeth), as follows: each group of 28 teeth mandibular left central incisors, (21, 31: see
of a different shade and with a different mould for
ISO 3950:1984). For the posterior teeth, measure the
each set of six anterior teeth and, wherever possible, Overall dimensions of the set (&, 17) and the maximum
different moulds for the five different sets of posterior
dimensions &, 2s) of the crowns of the maxillary and
teeth.
mandibular left first molars (26, 36).
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SIST EN ISO 3336:2000
ISO 3336:1993(E)
a) Dimensions of type I teeth
b) Dimensions of type II teeth
Figure 1 - Dimensions of teeth to be measured
6.3 Comparison with shade guide 6.4 Porosity and other defects
Select the cleaned maxillary central incisor (see
6.4.1 Apparatus
6.1.2) from each of the five different shades for
in with
evaluation. Evaluate accordance
ISO 7491:1985, subclause 3.2.2. Compare the labial
6.4.1.1 Instrument capable of x 8 to x 10 magni-
surfaces of each tooth to be tested to the shade guide
fication.
by holding the tooth alongside and in the same plane
as the corresponding shade guide tooth, with the test
tooth first on one side of the shade guide tooth and
then on the other. The tooth camplies with 4.2 if there 6.4.1.2 Abrasive Paper of mean grit particle size
is no perceptible colour differente. 8 Pm to 20 Pm, corresponding to grit grade 1 000.
3
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SIST EN ISO 3336:2000
6.4.1.3 Low-Speed cooled saw or wet-grinding 6.5.1.4 Dental gypsum for investment, complying
equipment. with ISO 6873:1983.
6.5.1.5 Precipitated Calcium carbonate (chalk) of
6.4.
...
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