SIST EN ISO 20795-1:2008

SLOVENSKI STANDARD
01-november-2008
Zobozdravstvo - Osnovni polimeri - 1. del: Osnovni polimeri za proteze (ISO 20795-
1:2008)
Dentistry - Base polymers - Part 1: Denture base polymers (ISO 20795-1:2008)
Zahnheilkunde - Kunststoffe - Teil 1: Prothesenkunststoffe (ISO 20795-1:2008)
Art dentaire - Polymères de base - Partie 1: Polymères pour base de prothèses dentaires
(ISO 20795-1:2008)
Ta slovenski standard je istoveten z: EN ISO 20795-1:2008
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 20795-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2008
ICS 11.060.10
English Version
Dentistry - Base polymers - Part 1: Denture base polymers (ISO
20795-1:2008)
Art dentaire - Polymères de base - Partie 1: Polymères Zahnheilkunde - Kunststoffe - Teil 1: Prothesenkunststoffe
pour base de prothèses dentaires (ISO 20795-1:2008) (ISO 20795-1:2008)
This European Standard was approved by CEN on 18 July 2008.
CEN members are 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 the CEN 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20795-1:2008: E
worldwide for CEN national Members.

Contents Page
Foreword.3

Foreword
This document (EN ISO 20795-1:2008) 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 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 2009, and conflicting national standards shall be withdrawn
at the latest by February 2009.
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.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 20795-1:2008 has been approved by CEN as a EN ISO 20795-1:2008 without any
modification.
INTERNATIONAL ISO
STANDARD 20795-1
First edition
2008-08-01
Dentistry — Base polymers —
Part 1:
Denture base polymers
Art dentaire — Polymères de base —
Partie 1: Polymères pour base de prothèses dentaires

Reference number
ISO 20795-1:2008(E)
©
ISO 2008
ISO 20795-1:2008(E)
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ii © ISO 2008 – All rights reserved

ISO 20795-1:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Classification. 3
5 Requirements . 4
5.1 Unpolymerized material . 4
5.2 Polymerized material. 4
6 Sampling. 6
7 Preparation of test specimens . 7
7.1 Laboratory environment . 7
7.2 Procedures . 7
7.3 Special equipment . 7
8 Test methods. 7
8.1 Inspection for compliance determination . 7
8.2 Packing plasticity. 8
8.3 Colour . 10
8.4 Colour stability. 10
8.5 Polishability, translucency, freedom from porosity, ultimate flexural strength and flexural
modulus . 12
8.6 Fracture toughness with a modified bending test . 17
8.7 Bonding to synthetic polymer teeth . 22
8.8 Residual methyl methacrylate monomer. 23
8.9 Water sorption and solubility . 28
9 Requirements for labelling, marking, packaging and instructions supplied by the
manufacturer . 30
9.1 Packaging . 30
9.2 Marking of outer packages and containers . 30
9.3 Manufacturer’s instructions . 31
Annex A (normative) HPLC method for determination of MMA content . 33
Bibliography . 36

ISO 20795-1:2008(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 2.
The main 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.
Attention 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 20795-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials.
This first edition cancels and replaces ISO 1567:1999 and Amendment 1:2003.
Significant differences between this first edition of ISO 20795-1 and the third edition of ISO 1567 and
Amendment 1 lie with requirements and tests for materials with improved impact resistance.
ISO 20795 consists of the following parts, under the general title Dentistry — Base polymers:
⎯ Part 1: Denture base polymers
⎯ Part 2: Orthodontic base polymers
iv © ISO 2008 – All rights reserved

ISO 20795-1:2008(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
part of ISO 20795, but it is recommended that in assessing possible biological or toxicological hazards,
reference be made to ISO 10993-1 and ISO 7405.

INTERNATIONAL STANDARD ISO 20795-1:2008(E)

Dentistry — Base polymers —
Part 1:
Denture base polymers
1 Scope
1.1 This part of ISO 20795 classifies denture base polymers and copolymers and specifies their
requirements. It also specifies the test methods to be used in determining compliance with these requirements.
It further specifies requirements with respect to packaging and marking the products and to the instructions to
be supplied for use of these materials. Furthermore it applies to denture base polymers for which the
manufacturer claims that the material has improved impact resistance. It also specifies the respective
requirement and the test method to be used.
1.2 Although this part of ISO 20795 does not require manufacturers to declare details of the composition,
attention is drawn to the fact that some national or international authorities require such details to be provided.
1.3 This part of ISO 20795 applies to denture base polymers such as those listed below:
a) poly(acrylic acid esters);
b) poly(substituted acrylic acid esters);
c) poly(vinyl esters);
d) polystyrene;
e) rubber modified poly(methacrylic acid esters);
f) polycarbonates;
g) polysulfones;
h) poly(dimethacrylic acid esters);
i) polyacetals (po
...