EN ISO 9917-1:2007
(Main)Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-1:2007)
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-1:2007)
ISO 9917-1:2007 specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. ISO 9917-1:2007 is applicable to both hand-mixed and capsulated cements for mechanical mixing. ISO 9917-1:2007 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 as a restorative material.
ISO 9917-1:2007 is not intended to address resin-modified water-based cements.
Zahnheilkunde - Wasserhärtende Zemente - Teil 1: Zemente, die beim Vermischen von Pulver und Flüssigkeit über eine Säure-Base-Reaktion abbinden (ISO 9917-1:2007)
Dieser Teil von ISO 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. Dieser Teil von ISO ISO 9917 gilt sowohl für Zemente zum Handmischen als auch für Zemente in Kapseln zum mechanischen Mischen. Dieser Teil von ISO ISO 9917 legt Grenzwerte für jede der Eigenschaften fest, je nachdem, ob der Zement für den Einsatz als Befestigungsmittel, als Unterfüllung oder als Füllungswerkstoff vorgesehen ist. Dieser Teil von ISO ISO 9917 gilt nicht für kunststoffmodifizierte wasserhärtende Zemente.
Art dentaire - Ciments à base d'eau - Partie 1: Ciments acido-basiques liquides/en poudre (ISO 9917-1:2007)
L'ISO 9917-1:2007 spécifie les exigences et les méthodes d'essai relatives aux ciments dentaires acido-basiques liquides/en poudre destinés à être utilisés pour scellement, fond de cavité ou restauration permanente. L'ISO 9917‑1:2007 est applicable à la fois aux ciments mélangés manuellement et aux ciments en capsules destinés au mélange mécanique. L'ISO 9917-1:2007 spécifie les limites pour chacune des propriétés, que le ciment soit destiné à être utilisé comme agent de scellement, base ou fond de cavité, ou comme matériau de restauration.
L'ISO 9917-1:2007 n'est pas destinée à traiter des ciments à base d'eau modifiés par la résine.
Zobozdravstvo - Cementi na osnovi vode - 1. del: Cementi, ki se vežejo na osnovi kislinsko-bazne reakcije mešanice prahu in tekočine (ISO 9917-1:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2008
1DGRPHãþD
SIST EN ISO 9917-1:2004
=RER]GUDYVWYR&HPHQWLQDRVQRYLYRGHGHO &HPHQWLNLVHYHåHMRQDRVQRYL
NLVOLQVNRED]QHUHDNFLMHPHãDQLFHSUDKXLQWHNRþLQH ,62
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-
1:2007)
Zahnheilkunde - Wasserhärtende Zemente - Teil 1: Zemente, die beim Vermischen von
Pulver und Flüssigkeit über eine Säure-Base-Reaktion abbinden (ISO 9917-1:2007)
Art dentaire - Ciments à base d'eau - Partie 1: Ciments acido-basiques liquides/en
poudre (ISO 9917-1:2007)
Ta slovenski standard je istoveten z: EN ISO 9917-1:2007
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
October 2007
ICS 11.060.10 Supersedes EN ISO 9917-1:2003
English Version
Dentistry - Water-based cements - Part 1: Powder/liquid acid-
base cements (ISO 9917-1:2007)
Art dentaire - Ciments à base d'eau - Partie 1: Ciments Zahnheilkunde - Wasserhärtende Zemente - Teil 1:
acido-basiques liquides/en poudre (ISO 9917-1:2007) Zemente, die beim Vermischen von Pulver und Flüssigkeit
über eine Säure-Base-Reaktion abbinden (ISO 9917-
1:2007)
This European Standard was approved by CEN on 8 October 2007.
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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9917-1:2007: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Foreword
This document (EN ISO 9917-1:2007) 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 April 2008, and conflicting national standards shall be withdrawn at the
latest by April 2008.
This document supersedes EN ISO 9917-1:2003.
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 9917-1:2007 has been approved by CEN as a EN ISO 9917-1:2007 without any modification.
INTERNATIONAL ISO
STANDARD 9917-1
Second edition
2007-10-01
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 9917-1:2007(E)
©
ISO 2007
ISO 9917-1:2007(E)
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ii © ISO 2007 – All rights reserved
ISO 9917-1:2007(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 Requirements . 3
9 Packaging, marking and information to be supplied by manufacturer. 4
Annex A (normative) Determination of net setting time. 7
Annex B (informative) Chemical composition 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 radio-opacity. 21
Bibliography . 23
ISO 9917-1:2007(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 second edition cancels and replaces the first edition (ISO 9917-1:2003), of which it constitutes a minor
revision.
The main purpose for modification of this part of ISO 9917 was to include a new test method for acid erosion,
a new test and requirement for radio-opacity and to distinguish between the requirements for manufacturer’s
instructions for hand-mixed cements and those for capsulated cements.
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 and ISO 10993-1.
A bibliography has been added to this document.
ISO 9917 consists of the following parts, under the general title Dentistry — Water-based cements:
⎯ Part 1: Powder/liquid acid-base cements
⎯ Part 2: Light-activated cements
iv © ISO 2007 – All rights reserved
INTERNATIONAL STANDARD ISO 9917-1:2007(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. This part of ISO 9917 is applicable to both hand-
mixed and capsulated cements for mechanical mixing. This part of ISO 9917 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 as a
restorative material. This part of ISO 9917 is not intended to address resin-modified water-based cements.
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 3665:1996, Photography — Intra-oral dental radiographic film — Specification
ISO 3696:1987, 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
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.
ISO 9917-1:2007(E)
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 such a product, the type of material for which
equivalence of properties is claimed shall be specified in accordance with 4.1 and 4.2 so that the correct
performance limits are applied.
4.2 Application
For the purposes of this part of ISO 9917, the application of water-based cements shall be classified as
follows:
a) luting;
b) bases or lining;
c) restoration.
5 Material
5.1 General
The cement shall consist of a powder and liquid which, when mixed in accordance with the manufacturer’s
instructions, shall conform to requirements in this clause and Clause 8.
5.2 Components
5.2.1 Liquid
For non-encapsulated cements, visually inspect the liquid. It shall be free from deposits or filaments on the
inside of its container. There shall be no visible signs of gelation.
5.2.2 Powder
For non-encapsulated cements, visually inspect the powder. It shall be free from extraneous material. If the
powder is coloured, the pigment sh
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