SIST EN ISO 9917-1:2004
(Main)Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-1:2003)
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-1:2003)
Migrated from Progress Sheet (TC Comment) (2000-07-10): draft BP: to be referenced to ISO/NP 9917-1. ISO?? (TA/990329)
Zahnheilkunde - Wasserhärtende Zemente - Teil 1: Zemente, die beim Vermischen von Pulver und Flüssigkeit über eine Säure-Base-Reaktion abbinden (ISO 9917-1:2003)
Dieser Teil von ISO 9917 legt Anforderungen an und Prüfverfahren für zahnärztliche wasserhärtende Zemente fest, die beim Vermischen von Pulver und Flüssigkeit über eine Säure-Base-Reaktion abbinden, und die für definitive Befestigungen, Unterfüllungen und Füllungen vorgesehen sind. Diese Norm gilt sowohl für Zemente zum Handmischen als auch für Zemente in Kapseln zum mechanischen Mischen. Diese Norm legt Grenzwerte für jede der Eigenschaften fest, je nachdem, ob der Zement für den Einsatz als Befestigungsmittel, als Unterfüllung oder als Füllungswerkstoff vorgesehen ist.
In diesem Teil von ISO 9917 werden keine besonderen qualitativen und quantitativen Anforderungen zum Ausschluss biologischer Risiken gestellt. Zur Beurteilung möglicher biologischer Risiken wird empfohlen, ISO 7405, Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials, und ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing heranzuziehen.
Art dentaire - Ciments a base d'eau - Partie 1: Ciments acido-basiques liquides/en poudre (ISO 9917-1:2003)
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-1:2003)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2004
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO
9917-1:2003)
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-
1:2003)
Zahnheilkunde - Wasserhärtende Zemente - Teil 1: Zemente, die beim Vermischen von
Pulver und Flüssigkeit über eine Säure-Base-Reaktion abbinden (ISO 9917-1:2003)
Art dentaire - Ciments a base d'eau - Partie 1: Ciments acido-basiques liquides/en
poudre (ISO 9917-1:2003)
Ta slovenski standard je istoveten z: EN ISO 9917-1:2003
ICS:
11.060.10
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 9917-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2003
ICS 11.060.10
English version
Dentistry - Water-based cements - Part 1: Powder/liquid acid-
base cements (ISO 9917-1:2003)
Art dentaire - Ciments à base d'eau - Partie 1: Ciments Zahnheilkunde - Wasserhärtende Zemente - Teil 1:
acido-basiques liquides/en poudre (ISO 9917-1:2003) Zemente, die beim Vermischen von Pulver und Flüssigkeit
über eine Säure-Base-Reaktion abbinden (ISO 9917-
1:2003)
This European Standard was approved by CEN on 3 October 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9917-1:2003 E
worldwide for CEN national Members.
CORRECTED 2003-12-17
Foreword
This document (EN ISO 9917-1:2003) 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 May 2004, and conflicting national standards
shall be withdrawn at the latest by May 2004.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 9917-1:2003 has been approved by CEN as EN ISO 9917-1:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 3696 1987 Water for analytical laboratory EN ISO 3696 1995
use – Specification and test
methods
ISO 7491 2000 Dental materials - Determination EN ISO 7491 2000
of colour stability
INTERNATIONAL ISO
STANDARD 9917-1
First edition
2003-11-01
Dentistry — Water-based cements —
Part 1:
Powder/liquid acid-base cements
Art dentaire — Ciments à base d'eau —
Partie 1: Ciments acido-basiques liquides/en poudre
Reference number
ISO 9917-1:2003(E)
©
ISO 2003
ISO 9917-1:2003(E)
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ii © ISO 2003 — All rights reserved
ISO 9917-1:2003(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Classification. 2
5 Material. 2
6 Preparation of test specimens. 3
7 Sampling. 3
8 Net setting time . 3
9 Film thickness (luting cements only). 3
10 Compressive strength. 3
11 Acid erosion. 4
12 Optical properties (polyalkenoate restorative cements only) . 4
13 Acid-soluble arsenic and lead contents . 4
14 Radiopacity. 4
15 Packaging, marking and information to be supplied by manufacturer. 4
Annex A (normative) Determination of net setting time. 7
Annex B (informative) Chemical compositions and applications of dental cements. 9
Annex C (normative) Determination of film thickness (luting cements only) . 10
Annex D (normative) Determination of compressive strength . 12
Annex E (normative) Determination of acid erosion . 14
Annex F (normative) Determination of optical properties (polyalkenoate restorative cements only) . 17
Annex G (normative) Determination of acid-soluble arsenic and lead contents. 20
Annex H (normative) Determination of radiopacity . 21
ISO 9917-1:2003(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 9917-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials.
This part of ISO 9917 cancels and replaces ISO 9917:1991, which has been technically revised.
ISO 9917 consists of the following parts, under the general title Dental materials — Water-based cements:
Part 1: Powder/liquid acid-base cements
Part 2: Light-activated cements
iv © ISO 2003 — All rights reserved
INTERNATIONAL STANDARD ISO 9917-1:2003(E)
Dentistry — Water-based cements —
Part 1:
Powder/liquid acid-base cements
1 Scope
This part of ISO 9917 specifies requirements and test methods for powder/liquid acid-base dental cements
intended for permanent cementation, lining and restoration. It is applicable to both hand-mixed cements and
encapsulated cements for mechanical mixing. It specifies limits for each of the properties according to whether
the cement is intended for use as a luting agent, a base or liner, or a restorative material.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
part of ISO 9917, but it is recommended that, in assessing possible biological or toxicological hazards,
reference should be made to ISO 7405, Dentistry — Preclinical evaluation of biocompatibility of medical
deviced used in dentistry — Test methods for dental materials, and ISO 10993-1, Biological evaluation of
medical devices — Part 1: Evaluation and testing.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 2590, General method for the determination of arsenic — Silver diethyldithiocarbamate photometric
method
ISO 3665, Photography — Intra-oral dental radiographic film — Specification
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 7491, Dental materials — Determination of colour stability
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
mixing time
that part of the working time required in order to obtain a satisfactory mix of the components
3.2
working time
period of time, measured from the start of mixing, during which it is possible to manipulate a dental material
without an adverse effect on its properties
ISO 9917-1:2003(E)
3.3
net setting time
period of time, measured from the end of mixing, until the material has set according to the criteria and
conditions specified in Annex A
NOTE For the purposes of this part of ISO 9917, in view of the wide variation in mixing times of cements, the net
setting time is determined from the end of mixing.
4 Classification
4.1 Chemical type
For the purposes of this part of ISO 9917, dental cements shall be classified on the basis of their chemical
composition, as follows:
a) zinc phosphate cement, see Clause B.1;
b) zinc polycarboxylate cement, see Clause B.2;
c) glass polyalkenoate cement, see Clause B.3.
Acid-base setting, water-based cements other than those listed above may fall within the scope of this part of
ISO 9917. If the manufacturer wishes to claim conformity for a par
...
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