Dentistry -- Water-based cements

ISO 9917‑2:2010 specifies requirements and test methods for dental cements that are intended for luting, base or lining and restoration purposes and for which the materials are water-based and set by multiple reactions in which setting is achieved by a combination of an acid-base reaction and polymerization.

Médecine bucco-dentaire -- Ciments à base d'eau

L'ISO 9917-2:2010 spécifie les exigences et les méthodes d'essai relatives aux ciments dentaires destinés ŕ ętre utilisés pour scellement, fond de cavité, revętement ou scellement et restauration. Les matériaux utilisés sont aqueux et leur prise est provoquée par de multiples réactions. La prise est obtenue par une association d'une réaction acido-basique et de la polymérisation.

General Information

Status
Replaced
Publication Date
11-Apr-2010
Withdrawal Date
11-Apr-2010
Current Stage
6060 - International Standard published
Start Date
22-Mar-2010
Completion Date
12-Apr-2010
Ref Project

RELATIONS

Effective Date
15-Apr-2008

Buy Standard

Standard
ISO 9917-2:2010 - Dentistry -- Water-based cements
English language
19 pages
sale 15% off
Preview
sale 15% off
Preview
Standard
ISO 9917-2:2010 - Dentistry -- Water-based cements
English language
19 pages
sale 15% off
Preview
sale 15% off
Preview
Standard
ISO 9917-2:2010 - Médecine bucco-dentaire -- Ciments à base d'eau
French language
21 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

INTERNATIONAL ISO
STANDARD 9917-2
Second edition
2010-04-15
Dentistry — Water-based cements —
Part 2:
Resin-modified cements
Médecine bucco-dentaire — Ciments à base d'eau —
Partie 2: Ciments modifiés par addition de résine
Reference number
ISO 9917-2:2010(E)
ISO 2010
---------------------- Page: 1 ----------------------
ISO 9917-2:2010(E)
PDF disclaimer

This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but

shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In

downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat

accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.

Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation

parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In

the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

COPYRIGHT PROTECTED DOCUMENT
© ISO 2010

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 either ISO at the address below or

ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2010 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 9917-2:2010(E)
Contents Page

Foreword ............................................................................................................................................................iv

Introduction.........................................................................................................................................................v

1 Scope......................................................................................................................................................1

2 Normative references............................................................................................................................1

3 Terms and definitions ...........................................................................................................................1

4 Classification and applications............................................................................................................2

4.1 Classification .........................................................................................................................................2

4.2 Applications ...........................................................................................................................................2

5 Requirements.........................................................................................................................................2

5.1 Materials .................................................................................................................................................2

5.2 Working time..........................................................................................................................................3

5.3 Setting time — Classes 1 and 3 materials only..................................................................................3

5.4 Film thickness — Luting cements only...............................................................................................3

5.5 Flexural strength ...................................................................................................................................3

5.6 Radio-opacity.........................................................................................................................................3

5.7 Shade and colour stability — Restorative materials only.................................................................3

6 Sampling.................................................................................................................................................3

7 Test conditions and preparation of test specimens ..........................................................................4

7.1 Test conditions ......................................................................................................................................4

7.2 Method of mixing...................................................................................................................................4

7.3 Inspection requirements.......................................................................................................................4

8 Packaging, marking and information to be supplied by the manufacturer.....................................4

8.1 Packaging...............................................................................................................................................4

8.2 Marking and instructions for use.........................................................................................................4

Annex A (normative) Determination of working time and setting time.........................................................7

Annex B (normative) Determination of film thickness — Luting materials only..........................................9

Annex C (normative) Determination of flexural strength..............................................................................11

Annex D (normative) Determination of radio-opacity ...................................................................................15

Annex E (normative) Determination of shade and colour stability — Restorative and luting

materials only ......................................................................................................................................18

Bibliography......................................................................................................................................................19

© ISO 2010 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 9917-2:2010(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 9917-2 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 9917-2:1998), which has been technically

revised by the inclusion of resin-modified cements which set by both chemically activated and light-activated

polymerization.

ISO 9917 consists of the following parts, under the general title Dentistry — Water-based cements:

⎯ Part 1: Powder/liquid acid-base cements
⎯ Part 2: Resin-modified cements
iv © ISO 2010 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 9917-2:2010(E)
Introduction

This part of ISO 9917 has been prepared in order to present the requirements and test methods for cements

in which setting is achieved by a combination of an acid-base reaction and polymerization. The polymerization

component of the reaction may be activated by mixing different components or through application of energy

from an external source. As far as possible, test methods employed within this part of ISO 9917 have been

harmonized with those used in ISO 4049 and ISO 9917-1.

Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this

part of ISO 9917, but it is recommended that reference be made to ISO 10993-1 and ISO 7405 when

assessing possible biological or toxicological hazards.
© ISO 2010 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 9917-2:2010(E)
Dentistry — Water-based cements —
Part 2:
Resin-modified cements
1 Scope

This part of ISO 9917 specifies requirements and test methods for dental cements that are intended for luting,

base or lining and restoration purposes and for which the materials are water-based and set by multiple

reactions in which setting is achieved by a combination of an acid-base reaction and polymerization.

EXAMPLE Conventional glass polyalkenoate cements are normally formed by reacting an ion-leachable

aluminosilicate glass with a polyalkenoic acid in an aqueous environment. Materials that fall within the scope of this part of

ISO 9917 will normally be able to effect setting by such an aqueous acid-base type reaction but in addition will be able to

undergo setting by polymerization.

NOTE Attention of manufacturers and test laboratories is drawn to the closely-related International Standards

ISO 4049 and ISO 9917-1. Consideration should be given as to which is the most appropriate International Standard by

which to evaluate any individual product.
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 1942, Dentistry — Vocabulary
ISO 3665:1996, 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

ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and

times
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.

3.1
mixing time

that part of the working time required in order to obtain a satisfactory mix of the components

NOTE Materials that fall within the scope of this part of ISO 9917 include materials that require mixing and single

component materials that do not require mixing.
© ISO 2010 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO 9917-2:2010(E)
3.2
working time

period of time, measured from start of mixing (if required), during which it is possible to manipulate the

material without an adverse effect on its properties

NOTE Working time is determined in the absence of activating radiation, if required for activation for Class 3

materials (see Clause 4).
3.3
setting time

period of time, from start of mix, until the completion of set, as defined by the ability of the material to support

an indenter under a known load
3.4
outer pack
form of packaging used to combine a number of single dose containers or capsules
3.5
outermost packaging

form of packaging used to combine material and additional items, including instructions for use and any

proportioning or mixing devices that are supplied with the material
4 Classification and applications
4.1 Classification

For the purposes of this part of ISO 9917, materials are classified on the basis of their setting characteristics

as follows.

⎯ Class 1: materials in which the setting reaction of the polymerizable component is activated chemically

following mixing of components.

⎯ Class 2: materials in which the setting reaction of the polymerizable component is light-activated.

⎯ Class 3: materials in which the setting reaction of the polymerizable component is activated chemically

following mixing of components and may also be light-activated.
4.2 Applications

For the purposes of this part of ISO 9917, the clinical application of these materials is signified as follows:

a) luting;
b) base or lining;
c) restoration.
5 Requirements
5.1 Materials

During the course of testing, there shall be no visible signs of extraneous matter in any component and

separately supplied liquid shall be free of any gelation.
2 © ISO 2010 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 9917-2:2010(E)
5.2 Working time

When tested in accordance with Annex A, the working time shall comply with the requirements given in

Table 1 and shall be at least as long as the value given by the manufacturer (see Table 2, item 24).

5.3 Setting time — Classes 1 and 3 materials only

When tested in accordance with Annex A, the setting time of Classes 1 and 3 materials shall comply with the

requirements given in Table 1 and shall be no longer than the value given by the manufacturer (see Table 2,

item 25).
5.4 Film thickness — Luting cements only (see 4.2)

When tested in accordance with Annex B, the film thickness of luting materials shall comply with the

requirements given in Table 1.
5.5 Flexural strength

When tested in accordance with Annex C, the flexural strength shall comply with the requirements given in

Table 1.
5.6 Radio-opacity

If the manufacturer claims that the material is radio-opaque (see Table 2, item 16), the radio-opacity,

determined in accordance with Annex D, shall be equal to or greater than that of the same thickness of

aluminium. If greater radio-opacity is claimed, it shall not be less than 0,5 mm below the value claimed by the

manufacturer (see Table 2, item 17).
5.7 Shade and colour stability — Restorative materials only

When tested in accordance with Annex E, the set material shall closely match that of the shade guide

specified by the manufacturer. When tested in accordance with Annex E and ISO 7491, there shall be no

more than a slight change in colour after 7 d.
Table 1 — Requirements for dental cements
Film thickness Working time Setting time Flexural strength
Application µm min MPa
min
Max. Min. Max. Min.
Luting 25 1,5 8 10
Base or lining — 1,5 6 10
Restoration — 1,5 6 25

Class 1 and 3 materials only. Class 3 materials tested without activation by light.

6 Sampling

A sample drawn from one batch shall provide sufficient material to complete all the prescribed tests plus an

allowance for any repeat tests, should they become necessary. The test sample shall consist of packages

prepared for retail sale.
© ISO 2010 – All rights reserved 3
---------------------- Page: 8 ----------------------
ISO 9917-2:2010(E)
7 Test conditions and preparation of test specimens
7.1 Test conditions

Prepare and test all specimens at an ambient temperature of (23 ± 2) °C. Control the relative humidity to

ensure that it remains at (50 ± 20) % at all times. If the material was refrigerated for storage, allow it to reach

(23 ± 2) °C. Test equipment should be maintained at the condition specified in individual tests.

For Classes 2 and 3 materials, activating radiation shall be excluded during the determination of working time.

Water used in all tests specified in this part of ISO 9917 shall be prepared in accordance with ISO 3696,

grade 2.

For Classes 2 and 3 materials, reference shall be made according to the manufacturer's instructions (see

Table 2, item 26), which state the external energy source to be used. Care shall be taken to ensure that the

source is in a satisfactory working condition.
7.2 Method of mixing

The cement shall be prepared according to the manufacturer's instructions. Sufficient cement shall be mixed

to ensure that the preparation of each specimen is completed from one mix. A fresh mix shall be prepared for

each specimen.

NOTE For encapsulated materials, more than one capsule, simultaneously mixed, might be required for certain

specimens. Likewise, for materials supplied in single dose containers, several containers might be required for each test

specimen.
7.3 Inspection requirements
Visual inspection shall be used in determining compliance with 5.1 and Clause 8.
8 Packaging, marking and information to be supplied by the manufacturer
8.1 Packaging

The components of the material shall be supplied in properly sealed containers which adequately protect their

contents and have no adverse effect on the quality of the product.
An outer pack may be used to present the individual containers as a single unit.

NOTE Single paste and powder-liquid encapsulated products can be sold as a pack containing many unit doses of

material.
8.2 Marking and instructions for use

Information shall be clearly marked on the outermost packaging or containers (for multi-dose packs or

capsules), as appropriate, and as indicated in Table 2.

Instructions shall accompany each package of the material and shall include the information appropriate to the

material (see Clause 4), as indicated in Table 2.

Information additional to that specified in Table 2 may be supplied at the discretion of the manufacturer.

NOTE Some information is indicated as mandatory and other as optional. The symbol “/ ” indicates that this item is

either irrelevant or optional for the product. Table 2 contains several optional references and serves as a guide to the

manufacturer as to the sort of information which might be useful to dentists.
4 © ISO 2010 – All rights reserved
---------------------- Page: 9 ----------------------
ISO 9917-2:2010(E)
Table 2 — Requirements for marking and instructions for use
Capsule
Outermost Outer pack
Manufacturer's
(single-dose),
packaging of capsules
Requirement instruction
syringes or
leaflet
see 3.5 see 3.4
bottles
a b
1 The name of the product. M M
/ M
2 The identification or name of the manufacturer. M M / M
The address of the manufacturer or the agent
3 M / / M
responsible for sale.
4 URL. / / / /
5 Information required by local/national legislation. M M / M
6 The recommended conditions of storage. M / / M
7 The manufacturer's batch number. M M / /
The expiry date, expressed in accordance with
8 ISO 8601, for the cement when stored under the M M / /
manufacturer's recommended conditions.
9 The shelf life under those conditions of storage. / / / /
10 The classification of the cement (see 4.1). M / / /
11 The clinical application (see 4.2). / / / M
The number of containers/capsules, for capsule or
12 M M / /
cartridge cements.
13 The net mass in each container/capsule. / M / M
Shade and/or colour of the cement according to the
14 manufacturer's nominated shade guide (for multi- / M M /
shade materials only).
If the material is designated opaque, a clear
15 M / / M
statement to this effect .
If the cement is designated radio-opaque (see 5.6), a
16 / / / M
clear statement to this effect.
If a specific claim on the extent of radio-opacity is
17 made, the equivalent thickness of aluminium for / / / M
1 mm thickness of the cement (see 5.6).
The recommended ratio of components
(e.g. powder:liquid) and instructions for use of any
18 proportioning aids (e.g. scoops, etc.) and the / / / M
proportions on a mass/mass basis to a precision of
0,1 g (for hand mixed materials only).
The rate of incorporation of the powder into the liquid
19 / / / M
(for hand-mixed materials only).
20 The mixing time (see 3.1), if mixing required. / / / M
The mixing condition (if appropriate, the condition
21 and type of the mixing slab and spatula). For / / / M
hand-mixed materials only.
For encapsulated cements, the method of bringing
22 about physical contact between the components, if / / / M
required.
The method, timing and type of mechanical mixing, if
23 / / / M
required.
© ISO 2010 – All rights reserved 5
---------------------- Page: 10 ----------------------
ISO 9917-2:2010(E)
Table 2 (continued)
Capsule
Outermost Outer pack
Manufacturer's
(single-dose),
packaging of capsules
Requirement instruction
syringes or
leaflet
see 3.5 see 3.4
bottles
24 The working time (see 3.2). / / / M
The setting time (for class 1 and 3 materials only,
25 / / / M
see 3.3).
The recommended external energy source(s),
26 exposure times and any special instructions for use / / / M
of the equipment (for class 2 and 3 materials only).
The maximum thickness of layer for polymerization
27 [class 2 and 3 materials for application b) and c) / / / M
only].
The minimum time at which finishing and polishing
28 / / / M
may be commenced (for restoration only, see 4.2).
The recommended method of finishing (for
29 / / / /
restoration only, see 4.2).
30 The necessity of varnish, if appropriate. / / / /
The precautions necessary to prevent premature
31 / / / M
activation of setting (class 2 and 3 cements only).

“/” indicates no relevance for this combination of container/marking/instructions or that such a requirement would be impracticable

or impossible or that the information may be informative but optional.
“M” indicates that an item is mandatory.

For individual/small dose containers, the individual containers shall have some means of identifying the colour/shade of the

material either directly or through reference to a key or guide in the instruction leaflet.

Opaque designation can be included in the shade.
6 © ISO 2010 – All rights reserved
---------------------- Page: 11 ----------------------
ISO 9917-2:2010(E)
Annex A
(normative)
Determination of working time and setting time
A.1 Apparatus

A.1.1 Test environment, capable of being maintained at a temperature of (37 ± 1) °C and a relative

humidity of at least 50 %.

A.1.2 Indenter, of a given mass and having a flat end with a given diameter. The tip shall be cylindrical for

approximately 5 mm. The indenter end shall be plane and perpendicular to its long axis.

A.1.2.1 Indenter for working time, of mass: (28,00 ± 0,25) g and diameter: (2,0 ± 0,1) mm.

A.1.2.2 Indenter for setting time, of mass: (400 ± 5) g and diameter: (1,0 ± 0,1) mm.

A.1.3 Metal mould, of thickness (5 ± 2) mm having a circular or square hole of (10 ± 2) mm diameter/length

cut in a sheet of metal at least 16 mm .
NOTE Internal corners of a square hole can be rounded.

A.1.4 Metal block, with a thickness of at least 8 mm and a volume of at least 60 cm .

A.1.5 Aluminium foil.
A.1.6 Timer, capable of reading to 1 s.
A.2 Determination of working time
A.2.1 Procedure

Classes 2 and 3 materials should be handled in the absence of light of wavelength 400 nm to 500 nm, for

example using a dark room and/or filtered light.
The test shall be performed under the conditions described in 7.1.

Place the mould (A.1.3), conditioned to (23 ± 1) °C, on the block (A.1.4) covered with the aluminium foil

(A.1.5), also conditioned to (23 ± 1) °C, and fill to a level surface with mixed cement.

Ten seconds before the end of the working time given by the manufacturer (see Table 2, item 24) or the

minimum value given in Table 1 (whichever is the longer), carefully lower the indenter (A.1.2.1) vertically on to

the surface of the cement and allow it to remain there for 5 s. Note whether the indenter makes a complete

circular indentation in the surface of the cement.
Repeat the test with two separate mixes of the material.
A.2.2 Treatment of results

In order to satisfy the requirements, the indenter shall make a complete circular indentation in the surface of

the cement specimen. All three values of indentation shall comply at 10 s before the working time stated by

the manufacturer (see Table 2, item 24) and with the minimum value of working time in Table 1.

© ISO 2010 – All rights reserved 7
---------------------- Page: 12 ----------------------
ISO 9917-2:2010(E)
A.3 Determination of setting time — Class 1 and 3 materials only

NOTE The purpose of this test is to confirm that Class 1 and Class 3 materials will set in the absence of light

activation.
A.3.1 Procedure

Place the mould (A.1.3), conditioned to (23 ± 1) °C, on the aluminium foil (A.1.5), mix or dispense the cement,

start the timer (A.1.6) and fill the mould to a level surface with mixed cement.

Sixty seconds after the end of mixing, place the assembly, comprising mould, foil and cement specimen, on

the block (A.1.4), in the test environment (A.1.1). Ensure good contact between the mould, foil and block.

Class 3 materials shall be tested without the use of activating light.

Ten seconds after the setting time stated by the manufacturer (see Table 2, item 25) or the limit value stated

in Table 1 (whichever is the shorter) carefully lower the indenter (A.1.2.2) vertically on to the surface of the

cement and allow it to remain there for 5 s. Remove the indenter from the surface and note whether the

indenter fails to make a complete circular indentation in the cement, when viewed using ×2 magnification.

Repeat the test two more times.
A.3.2 Treatment of results

In order to satisfy the requirements, the indenter shall fail to make a complete circular indentation in the

cement for all three tests. Materials which require light activation in order to set shall be designated as Class 2

materials.
8 © ISO 2010 – All rights reserved
---------------------- Page: 13 ----------------------
ISO 9917-2:2010(E)
Annex B
(normative)
Determination of film thickness — Luting materials only
B.1 Apparatus

B.1.1 Two glass plates, optically flat, square or circular, transparent, having a contact surface area of

(200 ± 25) mm . Each plate shall be of a uniform thickness of not less than 5 mm.

B.1.2 Loading device, of the type illustrated in Figure B.1, or an equivalent means, whereby a force of

(150 ± 2) N shall be generated vertically on the specimen via the upper glass plate.

The anvil that is attached to the bottom of the rod carrying the load shall be horizontal and parallel to the base.

The load shall be applied smoothly and in such a manner that no rotation occurs.

B.1.3 Screw micrometer or equivalent measuring instrument, having graduations of 1 µm or smaller.

B.2 Procedure

Measure and record to an accuracy of 1 µm the combined thickness of the two optically flat glass plates

(B.1.1) stacked in contact and designate this measurement reading A. Remove the upper plate and place

(0,10 ± 0,05) ml or the equivalent mass of the mixed cement in the centre of the lower plate and place this

centrally below the loading device (B.1.2) on the lower plate. Place the second glass plate centrally on the

cement in the same orientation as in the original measurement.

Ten seconds before the end of the manufacturer's stated working time (see Table 2, item 24), apply the load

to generate a force of (150 ± 2) N vertically and centrally to the specimen via the top plate. Ensure that the

cement has completely filled the space between the glass plates. When at least 10 min have elapsed after the

application of the load, remove the plates from the loading device and measure the combined thickness of the

two glass plates and the cement film in the same location. Designate this measurement reading B.

Record the difference in thickness of the plates with and without the cement film (reading B − reading A) as

the thickness of the film. Repeat the test four times.
B.3 Treatment of results

At least four of the five results shall be no more than 25 µm for the material to pass the requirement specified

in Table 1. If only two or less results are no more than 25 µm, then the material fails the requirement. If three

results are no more than 25 µm, a further five specimens shall be tested. To comply with the requirement

specified in Table 1, all the results in the second series of five shall be no more than 25 µm.

© ISO 2010 – All rights reserved 9
---------------------- Page: 14 ----------------------
ISO 9917-2:2010(E)
Key
1 specimen
2 glass discs
Figure B.1 — Loading device for use in film thickness test
10 © ISO 2010 – All rights reserved
---------------------- Page: 15 ----------------------
ISO 9917-2:2010(E)
Annex C
(normative)
Determination of flexural strength
C.1 Apparatus
C.1.1 Mould for the construction of specimens

The exact nature of the mould is not specified but shall enable specimens to be prepared according to the

manufacturer's instructions. Two examples of suitable moulds are given in C.1.1.1 and C.1.1.2.

C1.1.1 Mould, for the preparation of a test specimen (25 ± 2) mm × (2,0 ± 0,1) mm × (2,0 ± 0,1) mm.

A suitable mould is illustrated in Figure C.1. The mould may be constructed from stainless steel, a cast sheet

of PMMA [poly(methyl methacrylate)] or another suitable non-reactive mould material. A release agent may be

required to aid removal of specimens. If a release agent is used it shall have no effect on the setting of the

cement.
NOTE An example of a suitable release agent
...

DRAFT INTERNATIONAL STANDARD ISO/DIS 9917-2
ISO/TC 106/SC 1 Secretariat: SCC
Voting begins on: Voting terminates on:
2008-07-04 2008-12-04

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION

Dentistry — Water-based cements —
Part 2:
Resin-modified cements
Art dentaire — Ciments dentaires hydrauliques —
Partie 2: Ciments modifiés résineux
[Revision of first edition (ISO 9917-2:1998)]
ICS 11.060.10

In accordance with the provisions of Council Resolution 15/1993 this document is circulated in

the English language only.

Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué

en version anglaise seulement.

To expedite distribution, this document is circulated as received from the committee secretariat.

ISO Central Secretariat work of editing and text composition will be undertaken at publication

stage.

Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du

secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au

Secrétariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE

REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.

IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT

INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO

WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.

RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH

THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
International Organization for Standardization, 2008
---------------------- Page: 1 ----------------------
ISO/DIS 9917-2
PDF disclaimer

This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall

not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In

downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat

accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.

Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation

parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the

unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

Copyright notice

This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted

under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be

reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying,

recording or otherwise, without prior written permission being secured.

Requests for permission to reproduce should be addressed to either ISO at the address below or ISO's

member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii ISO 2008 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/WD 9917-2
Contents Page

Foreword ............................................................................................................................................................iv

Introduction…………………………………………………………………………………………………………… 1

1 Scope ......................................................................................................................................................1

2 Normative references............................................................................................................................2

3 Terms and definitions ...........................................................................................................................2

4 Classification and applications............................................................................................................3

5 Requirements.........................................................................................................................................4

6 Sampling………………………………………………………………………………………………………..4
7 Test conditions and preparation of test specimens…………………………………………………....5

8 Packaging, marking and information to be supplied by the manufacturer………………………. 5

Table 1 Some requirements for dental cements …………………………………………………………………8
Table 2 Requirements for marking and instructions for use 9
Annex A (normative) Determination of working time and setting time
Annex B (normative) Determination of film thickness (luting materials only)
Annex C (normative) Determination of flexural strength
Annex D (normative) Determination of radio-opacity

Annex E (normative) Determination of shade and colour stability (restorative materials only)

© ISO 2002 – All rights reserved iii
DRAFT 2008
---------------------- Page: 3 ----------------------
ISO/WD 9917-2
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 Electro technical Commission (IEC) on all matters of electro technical 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 9917-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Restorative

Materials.
This edition cancels and replaces the first edition (ISO 9917-2:1998)

ISO 9917 consists of the following parts, under the general title Water-based cements:

 Part 1: Powder/liquid acid-base cements
 Part 2: Resin–modified cements
iv © ISO 2002 – All rights reserved
DRAFT 2008
---------------------- Page: 4 ----------------------
WORKING DRAFT ISO/WD 9917-2
Dentistry — Water-based cements —
Part 2:
Resin-modified cements
Introduction

This International Standard has been prepared in order to present the requirements and

test methods for cements in which setting is achieved by a combination of an acid-base

reaction and polymerization. The polymerization component of the reaction may be

activated by mixing different components or through application of energy from an external

source. As far as possible test methods employed within this standard have been
harmonized with those used in ISO 4049 and ISO 9917-1.

Specific qualitative and quantitative requirements for freedom from biological hazard are not

included in this International Standard but it is recommended that when assessing possible

biological or toxicological hazards reference should be made to ISO 10993-1 and ISO 7405.

1 Scope

This International Standard specifies requirements and test methods for dental cements,

which are intended for lining, luting or restoration purposes and for which the materials are

water-based and set by multiple reactions in which setting is achieved by a combination of

an acid-base reaction and polymerisation.
Example:
Conventional glass polyalkenoate cements are normally formed by reacting an ion-

leachable aluminosilicate glass with a polyalkenoic acid in an aqueous environment.

Materials which fall within the scope of this standard will normally be able to effect setting

by such an aqueous acid-base type reaction but in addition will be able to undergo setting

by polymerization

NOTE: Attention of manufacturers and test laboratories is drawn to the following closely

related Standards. Consideration should be given as to which is the most appropriate

Standard by which to evaluate any individual product.

ISO 4049:2000 Dentistry -- Polymer-based filling, restorative and luting materials

ISO 9917-1:2003 Dentistry – Water-based cements. Part 1: Powder/liquid acid-base
cements
© ISO 2002 – All rights reserved 1
DRAFT 2008
---------------------- Page: 5 ----------------------
ISO/WD 9917-2
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 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 of dental polymeric materials.

ISO 9917-1: 2003, Dentistry -Water-based cements: Part 1 Powder/liquid acid-base
cements.
ISO 1942: 2007, Dentistry – Vocabulary

Informative Note: the preferred method for indicating dates and times is as specified in ISO

8601:2004, Data elements and interchange formats – information exchange –
Representation of dates and times.
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942 and the

following apply.
3.1
mixing time

For the purposes of this standard the mixing time shall be defined as that part of the

working time required in order to obtain a satisfactory mix of the components.

NOTE: materials which fall within the scope of this International Standard include both

materials which require mixing as well as single component no-mix materials.
3.2
working time
2 © ISO 2005 – All rights reserved
DRAFT 2008
---------------------- Page: 6 ----------------------
ISO/WD 9917-2

For the purposes of this standard the working time shall be defined as the period of time,

measured from start of mixing (if required), during which it is possible to manipulate the

material without an adverse effect on its properties.

NOTE: working time is determined in the absence of activating radiation, if required for

activation for Class 3 materials (see 4).
3.3
setting time

For the purposes of this standard, the setting time shall be defined as the period of time,

from start of mix, until the completion of set, as defined by the ability of the material to

support an indenter under a known load.
3.4
outer pack

A form of packaging used to combine a number of single dose containers or capsules.

3.5
outermost packaging

A form of packaging used to combine material and additional items including instructions for

use and any proportioning or mixing devices which are supplied with the material.

4 Classification and applications
4.1 Classification

For the purposes of this International Standard, materials are classified on the basis of their

setting characteristics as follows:
Class 1

These are materials in which the setting reaction of the polymerizable component is

activated chemically following mixing of components.
Class 2

These are materials in which the setting reaction of the polymerizable component is light-

activated.
Class 3
© ISO 2005 – All rights reserved 3
DRAFT 2008
---------------------- Page: 7 ----------------------
ISO/WD 9917-2

These are materials in which the setting reaction of the polymerizable component is

activated chemically following mixing of components and may also be light-activated.

4.2 Applications

For the purposes of this International Standard, the clinical application of these materials is

signified as follows:
a) Luting
b) Base or Lining
c) Restoration
5 Requirements
5.1
Materials

During the course of testing there shall be no visible signs of extraneous matter in any

component; separately supplied liquid shall be free of any gelation.
5.2 Working time
When tested in accordance with Annex A the Working Time shall comply with the

requirements given in Table 1 and shall be at least as long as the value given by the

manufacturer (see 8.2).
5.3 Setting time – Class 1 and 3 materials only

When tested in accordance with Annex A the Setting Time of Class 1 and 3 materials shall

comply with the requirements given in Table 1 and shall be no greater than the value given

by the manufacturer (see 8.2).
5.4 Film thickness – luting cements only (see 4.2)

When tested in accordance with Annex B the film thickness of luting materials shall comply

with the requirements given in Table 1.
5.5 Flexural Strength

When tested in accordance with Annex C the flexural strength shall comply with the

requirements given in Table 1.
4 © ISO 2005 – All rights reserved
DRAFT 2008
---------------------- Page: 8 ----------------------
ISO/WD 9917-2
5.6 Radio-opacity

If the manufacturer claims that the material is radio-opaque (see 8.2) the radio-opacity,

determined in accordance with Annex D shall be equal to or greater than that of the same

thickness of aluminium. If greater radio-opacity is claimed, it shall not be less than 0.5 mm

below the value claimed by the manufacturer (see 8.2).
5.7 Shade and Colour stability – (restorative materials only)

When tested in accordance with Annex E the set material shall match closely that of the

shade guide specified by the manufacturer. When tested in accordance with Annex E and

ISO 7491 there shall be no more than a slight change in colour after 7 days.
Table 1 — Requirements for dental cements
Film thickness Working time Setting time* Flexural
Strength
Application min min MPa
Max. Min. Max. Min.
Luting 25 1.5 8 10
Base or lining - 1.5 6 10
Restorative - 1.5 6 25

*Class 1 and 3 materials only. Class 3 materials tested without activation by light.

© ISO 2005 – All rights reserved 5
DRAFT 2008
---------------------- Page: 9 ----------------------
ISO/WD 9917-2
6 Sampling

A sample drawn from one batch shall provide sufficient material to complete all the

prescribed tests plus an allowance for any necessary repeat tests should they become

necessary. The test sample shall consist of packages prepared for retail sale.
7 Test conditions and preparation of test specimens
7.1 Test Conditions

Prepare and test all specimens at an ambient temperature of (23 ±2) °C. Control the

relative humidity to ensure that it remains at (50±20) RH% at all times. If the material was

refrigerated for storage, allow it to attain (23 ±2) °C. Test equipment should be maintained

at the condition specified in individual tests.

For Class 2 and 3 materials, activating radiation shall be excluded during the determination

of working time.

Water used in all tests specified in this standard shall be prepared in accordance with ISO

3696 Grade 2.

For Class 2 and 3 materials, reference shall be made to the manufacturer’s instructions

(see 8.2) which state the external energy source to be used. Care shall be taken to ensure

that the source is in a satisfactory working condition.
7.2 Method of Mixing

The cement shall be prepared according to the manufacturer’s instructions. Sufficient

cement shall be mixed to ensure that the preparation of each specimen is completed from

one mix. A fresh mix shall be prepared for each specimen.

NOTE: For encapsulated materials, more than one capsule, simultaneously mixed, may be

required for certain specimens. Likewise, for materials supplied in single dose containers

several containers may be required for each test specimen.
7.3 Inspection Requirements
Visual inspection shall be used in determining compliance with 5.1, and 8.
6 © ISO 2005 – All rights reserved
DRAFT 2008
---------------------- Page: 10 ----------------------
ISO/WD 9917-2
8 Packaging, marking and information to be supplied by the manufacturer
8.1 Packaging

The components of the material shall be supplied in properly sealed containers which

adequately protect their contents and have no adverse effect on the quality of the product.

a) An outer pack may be used to present the individual containers as a single unit.

8.2 Marking and instructions for use

a) Information shall be clearly marked on the outermost packaging or containers (for multi-

dose packs or capsules) as appropriate and as indicated in Table 2.

b) Instructions shall accompany each package of the material and shall include the

information, appropriate to the material (see 4) as indicated in Table 2.

c) Information additional to that specified in Table 2 may be supplied at the discretion of the

manufacturer.

NOTE: some information is indicated as mandatory and other as optional. A symbol of /

indicates that this item is either irrelevant or optional for the product. Table 2 contains

several optional references and serves as a guide to the manufacturer as to the sort of

information which may be useful to dentists.
© ISO 2005 – All rights reserved 7
DRAFT 2008
---------------------- Page: 11 ----------------------
ISO/WD 9917-2
Table 2 – Requirements for marking and instructions for use
Capsule
Outer
Outermost (single- Manufacturer's
M: mandatory pack of
pack dose), Instructions
/: irrelevant, impracticable or optional capsules
see 3.5 syringes leaflet
see 3.4
or bottles
1 the name of the product M M / M
the identification or name of the
M M / M
manufacturer
the address of the manufacturer or the
M / / M
agent responsible for sale
URL / / / /
information required by local/national
M M / M
legislation
the recommended conditions of storage M / / M
7 the manufacturer's batch number M M / /
the expiry date ,expressed in accordance
with ISO 8601:2004, for the cement when
M M / /
stored under the manufacturer’s
recommended conditions
the shelf life under those conditions of
/ / / /
storage
the classification of the cement (see 4.1) M / / M
the clinical application (see 4.2) / / / M
the number of containers/capsules, for
M M / /
capsule or cartridge cements
the net mass in each container/capsule / M / M
8 © ISO 2005 – All rights reserved
DRAFT 2008
---------------------- Page: 12 ----------------------
ISO/WD 9917-2
shade and/or colour of the cement
according to the manufacturer's
/ M / /
nominated shade guide (for multi-shade
materials only)
if the material is designated opaque a
clear statement to this effect (Note:
M / / M
Opaque designation can be included in
the shade)
if the cement is designated radio-opaque
/ / / M
(see 5.6) a clear statement to this effect
if a specific claim on the extent of radio-
opacity is made, the equivalent thickness
/ / / M
of aluminium for 1 mm thickness of the
cement (see 5.6)
the recommended ratio of components
(e.g. powder/liquid) and instructions for
use of any proportioning aids (e.g. scoops
18 / / / M
etc) and the proportions on a mass/mass
basis to a precision of 0.1 g. (For hand
mixed materials only)
the rate of incorporation of the powder into
/ / / M
the liquid. For hand mixed materials only
the mixing time (see 3.1), if mixing
20 / / / M
required
the mixing condition (if, appropriate, the
condition and type of the mixing slab and / / / M
spatula). For hand mixed materials only.
for encapsulated cements, the method of
bringing about physical contact between / / / M
the components, if required
© ISO 2005 – All rights reserved 9
DRAFT 2008
---------------------- Page: 13 ----------------------
ISO/WD 9917-2
the method, timing and type of mechanical
/ / / M
mixing, if required
the working time (see 3.2) / / / M
the setting time (for class 1 and 3
/ / / M
materials only, see 3.3)
the recommended external energy
source(s), exposure times and any special
/ / / M
instructions for use of the equipment (for
class 2 and 3 materials only)
the maximum thickness of layer for curing
/ / / M
(class 2 and 3 cements only)
the minimum time at which finishing and
polishing may be commenced (for / / / M
restorative cements only, see 4.2)
the recommended method of finishing (for
29 / / / /
restorative cements only, see 4.2)
the necessity of varnish, if appropriate / / / /
the precaution necessary to prevent
premature activation of setting (class 2 / / / M
and 3 cements only)

/ - indicates no relevance for this combination of container/marking/instructions or that such a requirement would be

impracticable or impossible or that the information may be informative but optional.

10 © ISO 2005 – All rights reserved
DRAFT 2008
---------------------- Page: 14 ----------------------
ISO/WD 9917-2
Annex A (normative)
Determination of working time and setting time
A.1 Apparatus

A.1.1 A test environment capable of being maintained at a temperature of (37 ±1) °C

and a relative humidity of at least 50 %.

A.1.2 Indenter of mass (400 ± 5) g and having a flat end of diameter (1,00 ± 0,02) mm.

The tip shall be cylindrical for approximately 5 mm. The indenter end shall be plane and

perpendicular to the long axis of the needle.

A.1.3 Metal mould of thickness (5± 2) mm having a circular or square hole of (10 ± 2) mm

diameter/length cut in a sheet of metal at least 16 mm square.
NOTE: Internal corners of a square hole can be rounded.

A.1.4 Metal block with a thickness of at least 8 mm and a volume of at least 60 cm .

A.1.5 Aluminium foil.
A.1.6 Timer capable of reading to 1 s.
A.2 Determination of Working Time

A.2.1 Procedure (Class 2 and 3 materials should be handled in the absence of light of

wavelength 400-500 nm e.g. using a dark room and/or filtered light).
The test shall be performed under the conditions as described in clause 7.1.

Place the mould (A.1.3), conditioned to (23 ± 1) °C, on the block (A.1.4) covered with the

aluminium foil (A.1.5) also conditioned to (23 + 1) °C and fill to a level surface with mixed

cement.

Load the indenter (A.1.2) 60 s after the end of mixing, or after dispensing from the container

for no-mix materials, for 5 s. Using the timer (A.1.6) note the time from start of mixing or

© ISO 2005 – All rights reserved 11
DRAFT 2008
---------------------- Page: 15 ----------------------
ISO/WD 9917-2

dispensing (for no mix materials) and apply a second indentation at 10 s before the end of

the manufacturers stated working time (see clause 8.2) or the value in table 1, whichever is

longer, for 5 s and note if the indenter fails to penetrate within 0.1 mm of the bottom surface

of the cement.
Repeat the test with two separate mixes of the material.
A.2.2 Treatment of results

In order to satisfy the requirements all three values of penetration shall be to within 0.1 mm

of the bottom surface of the cement at 60 s after mixing and dispensing and at 10 s before

the Working Time stated by the manufacturer (see clause 8.2) and shall comply with the

minimum value of WT in Table 1.
A.3 Determination of setting time (Class 1 and 3 materials only)
A.3.1 Procedure

Place the mould (A.1.3), conditioned to (23+1) °C, on the aluminium foil (A.1.5), mix or

dispense the cement, start the timer (A.1.6) and fill the mould to a level surface with mixed

cement.

Sixty seconds after the end of mixing, place the assembly, comprising mould, foil and

cement specimen, on the block (A.1.4), in the test environment (A.1.1). Ensure good

contact between the mould, foil and block.
NOTE: Class 3 materials shall be tested without use of activating light.

10s after the setting time stated by the manufacturer (see 8.2) or the limit value stated in

table 2 (whichever is shorter) carefully lower the indenter (A.1.2) vertically onto the surface

of the cement and allow it to remain there for 5 s. Remove the indenter from the surface

and note whether the indenter fails to make a complete circular indentation in the cement,

when viewed using x 2 magnification.
Repeat the test two more times.
A.4 Treatment of results

In order to satisfy the requirements the indenter shall fail to make a complete circular

indentation in the cement for all three tests.
12 © ISO 2005 – All rights reserved
DRAFT 2008
---------------------- Page: 16 ----------------------
ISO/WD 9917-2
Annex A (normative)
Determination of film thickness (Luting materials only)
B.1 Apparatus

B.1.1 Two glass plates, optically flat, square or circular, transparent, having a contact

surface area of (200 ± 25) mm . Each plate shall be of a uniform thickness of not less than

5 mm.

B.1.2 Loading device, of the type illustrated in Figure B.1, or an equivalent means,

whereby a force of (150 ± 2) N shall be generated vertically on the specimen via the upper

glass plate.

The anvil which is attached to the bottom of the rod carrying the load shall be horizontal

and parallel to the base. The load shall be applied smoothly and in such a manner that no

rotation occurs.

B.1.3 Screw micrometer or equivalent measuring instrument, having graduations of 1

µm or smaller.
B.2 Procedure

Measure and record to an accuracy of 1 µm the combined thickness of the two optically flat

glass plates (B.1.1) stacked in contact and designate this measurement reading A. Remove

the upper plate and place (0,10 ± 0,05) mL or the equivalent mass of the mixed cement in

the centre of the lower plate and place this centrally below the loading device (B.1.2) on the

lower platen. Place the second glass plate centrally on the cement in the same orientation

as in the original measurement.

Ten seconds before the end of the manufacturer’s stated working time (clause 8.2), apply

the load to generate a force of (150 ± 2) N vertically and centrally to the specimen via the

top plate. Ensure that the cement has completely filled the space between the glass plates.

When at least 10 min have elapsed after the application of the load, remove the plates from

the loading device and measure the combined thickness of the two glass plates and the

cement film in the same location as measurement A. Designate this measurement reading

Record the difference in thickness of the plates with and without the cement film (reading B

- reading A) as the thickness of the film. Repeat the test four times.
B.3 Treatment of results

At least four of the five results shall be no more than 25 µm for the material to pass the

requirement specified in Table 1. If only two or less results are no more than 25 µm, then

the material shall fail the requirement. If three results are no more than 25 µm, a further five

specimens shall be tested. To comply with the requirement specified in Table 1, all the

specimens in the second series of five shall be no more than 25 µm.
© ISO 2005 – All rights reserved 13
DRAFT 2008
---------------------- Page: 17 ----------------------
ISO/WD 9917-2
Figure B.1 — Loading device for use in film thickness test
14 © ISO 2005 – All rights reserved
DRAFT 2008
---------------------- Page: 18 ----------------------
ISO/WD 9917-2
Annex C (normative)
Determination of flexural strength
C.1 Apparatus
C.1.1 Mould for the construction of specimens

The exact nature of the mould is not specified but shall enable specimens to be prepared

according to the manufacturers instructions. Two examples of suitable moulds are given in

C.1.1.1 and C.1.1.2.

C.1.1.1 Mould for the preparation of a test specimen (25 ± 2) mm x (2,0 ± 0,1) mm x (2,0 ±

0,1) mm. A suitable mould is illustrated in Figure C.1. The mould may be constructed from

stainless steel, cast sheet of PMMA or another suitable non-reactive mould material. A

release agent may be required to aid removal of specimens. If a release agent is used it

shall have no effect on the setting of the cement.

NOTE: an example of a suitable release agent is a 3% solution of paraffin wax in hexane.

Figure C.1 – Mould for flexural strength specimens.
© ISO 2005 – All rights reserved 15
DRAFT 2008
---------------------- Page: 19 ----------------------
ISO/WD 9917-2
C.1.1.2 An alternative mould for specimen preparation is shown in Figure C.2.

The mould blocks shall be constructed from sheet PMMA to avoid sticking. The moulds

shall be regularly inspected and replaced when damaged or worn. A release agent may be

required to aid removal of specimens. If a release agent is used it shall have no effect on

the setting of the cement.

NOTE: an example of a suitable release agent is a 3% solution of paraffin wax in hexane.

The mould is used in conjunction with a levelling press which may be constructed from any

rigid material (constructed from alumini
...

NORME ISO
INTERNATIONALE 9917-2
Deuxième édition
2010-04-15
Médecine bucco-dentaire — Ciments à
base d'eau —
Partie 2:
Ciments modifiés par addition de résine
Dentistry — Water-based cements —
Part 2: Resin-modified cements
Numéro de référence
ISO 9917-2:2010(F)
ISO 2010
---------------------- Page: 1 ----------------------
ISO 9917-2:2010(F)
PDF – Exonération de responsabilité

Le présent fichier PDF peut contenir des polices de caractères intégrées. Conformément aux conditions de licence d'Adobe, ce fichier

peut être imprimé ou visualisé, mais ne doit pas être modifié à moins que l'ordinateur employé à cet effet ne bénéficie d'une licence

autorisant l'utilisation de ces polices et que celles-ci y soient installées. Lors du téléchargement de ce fichier, les parties concernées

acceptent de fait la responsabilité de ne pas enfreindre les conditions de licence d'Adobe. Le Secrétariat central de l'ISO décline toute

responsabilité en la matière.
Adobe est une marque déposée d'Adobe Systems Incorporated.

Les détails relatifs aux produits logiciels utilisés pour la création du présent fichier PDF sont disponibles dans la rubrique General Info

du fichier; les paramètres de création PDF ont été optimisés pour l'impression. Toutes les mesures ont été prises pour garantir

l'exploitation de ce fichier par les comités membres de l'ISO. Dans le cas peu probable où surviendrait un problème d'utilisation,

veuillez en informer le Secrétariat central à l'adresse donnée ci-dessous.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2010

Droits de reproduction réservés. Sauf prescription différente, aucune partie de cette publication ne peut être reproduite ni utilisée sous

quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les microfilms, sans l'accord écrit

de l'ISO à l'adresse ci-après ou du comité membre de l'ISO dans le pays du demandeur.

ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Publié en Suisse
ii © ISO 2010 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 9917-2:2010(F)
Sommaire Page

Avant-propos .....................................................................................................................................................iv

Introduction.........................................................................................................................................................v

1 Domaine d'application ..........................................................................................................................1

2 Références normatives.........................................................................................................................1

3 Termes et définitions ............................................................................................................................1

4 Classification et applications...............................................................................................................2

4.1 Classification .........................................................................................................................................2

4.2 Applications ...........................................................................................................................................2

5 Exigences...............................................................................................................................................3

5.1 Produits ..................................................................................................................................................3

5.2 Temps de travail ....................................................................................................................................3

5.3 Temps de prise — Produits de classes 1 et 3 uniquement...............................................................3

5.4 Épaisseur de film — Ciments de scellement uniquement ...............................................................3

5.5 Résistance à la flexion..........................................................................................................................3

5.6 Radio-opacité.........................................................................................................................................3

5.7 Stabilité de teinte et de couleur — Ciments de restauration uniquement.......................................3

6 Échantillonnage.....................................................................................................................................4

7 Conditions d'essai et préparation des éprouvettes...........................................................................4

7.1 Conditions d'essai.................................................................................................................................4

7.2 Méthode de mélange .............................................................................................................................4

7.3 Exigences relatives au contrôle...........................................................................................................4

8 Emballage, marquage et informations à fournir par le fabricant .....................................................4

8.1 Emballage...............................................................................................................................................4

8.2 Marquage et mode d'emploi .................................................................................................................5

Annexe A (normative) Détermination du temps de travail et du temps de prise .........................................8

Annexe B (normative) Détermination de l'épaisseur du film — Ciments de scellement uniquement .....10

Annexe C (normative) Détermination de la résistance à la flexion..............................................................12

Annexe D (normative) Détermination de la radio-opacité ............................................................................16

Annexe E (normative) Détermination de la stabilité de teinte et de couleur — Produits de

restauration et de scellement uniquement .......................................................................................20

Bibliographie.....................................................................................................................................................21

© ISO 2010 – Tous droits réservés iii
---------------------- Page: 3 ----------------------
ISO 9917-2:2010(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux de

normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général confiée

aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire partie du

comité technique créé à cet effet. Les organisations internationales, gouvernementales et non

gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec

la Commission électrotechnique internationale (CEI) en ce qui concerne la normalisation électrotechnique.

Les Normes internationales sont rédigées conformément aux règles données dans les Directives ISO/CEI,

Partie 2.

La tâche principale des comités techniques est d'élaborer les Normes internationales. Les projets de Normes

internationales adoptés par les comités techniques sont soumis aux comités membres pour vote. Leur

publication comme Normes internationales requiert l'approbation de 75 % au moins des comités membres

votants.

L'attention est appelée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable de ne

pas avoir identifié de tels droits de propriété et averti de leur existence.

L'ISO 9917-2 a été élaborée par le comité technique ISO/TC 106, Art dentaire, sous-comité SC 1, Produits

pour obturation et restauration.

Cette deuxième édition annule et remplace la première édition (ISO 9917-2:1998), qui a fait l'objet d'une

révision technique afin d'inclure les ciments modifiés par addition de résine dont la prise est provoquée à la

fois par polymérisation activée chimiquement et polymérisation photo-activée.

L'ISO 9917 comprend les parties suivantes, présentées sous le titre général Art dentaire — Ciments à base

d'eau:
⎯ Partie 1: Ciments acido-basiques liquides/en poudre
⎯ Partie 2: Ciments modifiés par addition de résine
iv © ISO 2010 – Tous droits réservés
---------------------- Page: 4 ----------------------
ISO 9917-2:2010(F)
Introduction

La présente partie de l'ISO 9917 a été élaborée afin de présenter les exigences et les méthodes d'essai

relatives aux ciments dans lesquels la prise est obtenue par l'association d'une réaction acido-basique et

d'une polymérisation. La partie polymérisation de la réaction peut être activée par le mélange de plusieurs

composants ou par une source d'énergie extérieure. Dans la mesure du possible, les méthodes d'essai

appliquées dans la présente partie de l'ISO 9917 ont été harmonisées avec celles utilisées dans l'ISO 4049 et

dans l'ISO 9917-1.

Aucune exigence qualitative et quantitative spécifique relative à l'absence de risques biologiques n'est incluse

dans la présente partie de l'ISO 9917, mais il est recommandé que, pour l'évaluation des éventuels risques

biologiques ou toxicologiques, référence soit faite à l'ISO 10993-1 et à l'ISO 7405.

© ISO 2010 – Tous droits réservés v
---------------------- Page: 5 ----------------------
NORME INTERNATIONALE ISO 9917-2:2010(F)
Médecine bucco-dentaire — Ciments à base d'eau —
Partie 2:
Ciments modifiés par addition de résine
1 Domaine d'application

La présente partie de l'ISO 9917 spécifie les exigences et les méthodes d'essai relatives aux ciments

dentaires destinés à être utilisés pour scellement, fond de cavité, revêtement ou scellement et restauration.

Les matériaux utilisés sont aqueux et leur prise est provoquée par de multiples réactions. La prise est obtenue

par une association d'une réaction acido-basique et de la polymérisation.

EXEMPLE Les ciments traditionnels au polyalkénoate de verre sont généralement formés par réaction d'un verre

aluminosilicate libérant des ions en présence d'un acide polyalkénoïde dans un milieu aqueux. Les produits relevant du

domaine d'application de la présente partie de l'ISO 9917 sont normalement susceptibles de provoquer la prise par cette

réaction de type acido-basique en milieu aqueux mais peuvent, de plus, faire l'objet d'une prise par réaction de

polymérisation.

NOTE L'attention des fabricants et des laboratoires d'essai est attirée sur les Normes internationales ISO 4049 et

ISO 9917-1. Il est préférable de prendre en considération quelle est la Norme internationale la mieux adaptée pour

évaluer un produit particulier.
2 Références normatives

Les documents de référence suivants sont indispensables pour l'application du présent document. Pour les

références datées, seule l'édition citée s'applique. Pour les références non datées, la dernière édition du

document de référence s'applique (y compris les éventuels amendements).
ISO 1942, Médecine bucco-dentaire — Vocabulaire

ISO 3665:1996, Photographie — Film pour la radiographie dentaire intrabuccale — Spécifications

ISO 3696, Eau pour laboratoire à usage analytique — Spécification et méthodes d'essai

ISO 7491, Produits dentaires — Détermination de la stabilité de couleur

ISO 8601, Éléments de données et formats d'échange — Échange d'information — Représentation de la date

et de l'heure
3 Termes et définitions

Pour les besoins du présent document, les termes et définitions donnés dans l'ISO 1942 ainsi que les

suivants s'appliquent.
3.1
temps de mélange

partie du temps de travail nécessaire pour obtenir un mélange satisfaisant des composants

NOTE Les matériaux relevant du domaine d'application de la présente partie de l'ISO 9917 englobent les produits qui

nécessitent d'être mélangés et les produits monocomposant ne nécessistant aucun mélange.

© ISO 2010 – Tous droits réservés 1
---------------------- Page: 6 ----------------------
ISO 9917-2:2010(F)
3.2
temps de travail

durée, mesurée depuis le début du mélange, pendant laquelle un produit dentaire peut être manipulé sans

altération de ses propriétés

NOTE Le temps de travail est déterminé en l'absence de rayonnement activant, si celui-ci est requis pour l'activation

des produits de classe 3 (voir Article 4).
3.3
temps de prise

durée comprise entre le début du mélange et la fin de la prise, celle-ci étant définie par l'aptitude du produit à

résister à la force exercée par un pénétrateur de charge connue
3.4
emballage externe

type d'emballage utilisé pour regrouper un certain nombre de conteneurs de dose unitaire ou capsules

3.5
emballage extérieur

type d'emballage utilisé pour regrouper le produit et les articles additionnels, y compris le mode d'emploi et les

éventuels appareils de dosage et de mélange fournis avec le produit
4 Classification et applications
4.1 Classification

Pour les besoins de la présente partie de l'ISO 9917, les produits sont classés en fonction de leurs

caractéristiques de prise de la manière suivante:

⎯ classe 1: produits dans lesquels la réaction de prise du composant polymérisable est activée

chimiquement à la suite du mélange des composants;

⎯ classe 2: produits dans lesquels la réaction de prise du composant polymérisable se fait par photo-

activation;

⎯ classe 3: produits pour lesquels la réaction de prise du composant polymérisable est activée

chimiquement à la suite du mélange des composants, la prise pouvant également s'effectuer par photo-

activation.
4.2 Applications

Pour les besoins de la présente partie de l'ISO 9917, l'application clinique de ces produits est classée de la

manière suivante:
a) scellement;
b) fond de cavité ou revêtement;
c) restauration.
2 © ISO 2010 – Tous droits réservés
---------------------- Page: 7 ----------------------
ISO 9917-2:2010(F)
5 Exigences
5.1 Produits

Au cours des essais, aucune trace de substances étrangères ne doit être visible dans un composant

quelconque; les composants liquides fournis séparément doivent être exemptes de gélification.

5.2 Temps de travail

Lors des essais réalisés conformément à l'Annexe A, le temps de travail doit satisfaire aux exigences

énoncées dans le Tableau 1 et sa durée doit être au moins aussi longue que la valeur indiquée par le

fabricant (voir Tableau 2, point 24).
5.3 Temps de prise — Produits de classes 1 et 3 uniquement

Lors des essais réalisés conformément à l'Annexe A, le temps de prise des produits de classes 1 et 3 doit

satisfaire aux exigences énoncées dans le Tableau 1 et sa durée doit être inférieure ou égale à la valeur

indiquée par le fabricant (voir Tableau 2, point 25).
5.4 Épaisseur de film — Ciments de scellement uniquement (voir 4.2)

Lors des essais réalisés conformément à l'Annexe B, l'épaisseur de film des produits de scellement doit

satisfaire aux exigences énoncées dans le Tableau 1.
5.5 Résistance à la flexion

Lors des essais réalisés conformément à l'Annexe C, la résistance à la flexion doit satisfaire aux exigences

énoncées dans le Tableau 1.
5.6 Radio-opacité

Si le fabricant déclare que le produit est radio-opaque (voir Tableau 2, point 16), la radio-opacité, déterminée

conformément à l'Annexe D, doit être égale ou supérieure à l'épaisseur équivalente d'aluminium. Si une radio-

opacité supérieure est déclarée, elle ne doit pas être inférieure de plus de 0,5 mm à la valeur déclarée par le

fabricant (voir Tableau 2, point 17).
5.7 Stabilité de teinte et de couleur — Ciments de restauration uniquement

Lors des essais réalisés conformément à l'Annexe E, la teinte du produit dont la prise s'est effectuée doit

correspondre étroitement au nuancier spécifié par le fabricant. Lors des essais réalisés conformément à

l'Annexe E et à l'ISO 7491, il doit y avoir au plus un léger changement de couleur au bout de 7 jours.

Tableau 1 — Exigences relatives aux ciments dentaires
Épaisseur de film Temps de travail Temps de prise Résistance à la
flexion
Application
µm min min MPa
max. min. max. min.
Scellement 25 1,5 8 10
Fond de cavité ou revêtement — 1,5 6 10
Restauration — 1,5 6 25

Produits de classes 1 et 3 uniquement. Les produits de classe 3 ont été soumis à essai en l'absence de photo-activation.

© ISO 2010 – Tous droits réservés 3
---------------------- Page: 8 ----------------------
ISO 9917-2:2010(F)
6 Échantillonnage

Un échantillon prélevé sur un lot doit fournir suffisamment de produit pour réaliser tous les essais spécifiés

plus une marge de tolérance pour les éventuels contre-essais, s'il est nécessaire d'y avoir recours.

L'échantillon pour essai doit se composer de paquets préparés pour la vente au détail.

7 Conditions d'essai et préparation des éprouvettes
7.1 Conditions d'essai

Préparer et soumettre à essai la totalité des éprouvettes à une température ambiante de (23 ± 2) °C.

Contrôler le degré d'humidité relative afin de s'assurer qu'il se maintient, à tout moment, à (50 ± 20) %. Si le

produit a été réfrigéré pour les besoins du stockage, le laisser revenir à une température de (23 ± 2) °C. Il

convient de maintenir l'appareillage d'essai aux conditions spécifiées pour les essais individuels.

Pour les produits de classes 2 et 3, le rayonnement activant doit être exclu lors de la détermination du temps

de travail.

L'eau utilisée au cours de tous les essais spécifiés dans la présente partie de l'ISO 9917 doit être de qualité 2

conformément à l'ISO 3696.

Pour les produits de classes 2 et 3, il doit être fait référence aux instructions fournies par le fabricant (voir

Tableau 2, point 26) qui indiquent la source d'énergie externe à utiliser. Veiller à s'assurer que la source est

dans un état de fonctionnement satisfaisant.
7.2 Méthode de mélange

Le ciment doit être préparé suivant les instructions du fabricant. Une quantité suffisante de ciment doit être

mélangée pour garantir que la préparation de chaque éprouvette s'effectue à partir d'un seul mélange. Un

mélange frais doit être préparé pour chaque éprouvette.

NOTE Pour les produits en capsules, il peut s'avérer nécessaire, pour certaines éprouvettes, d'utiliser plusieurs

capsules mélangées simultanément. De même, pour les produits fournis en prédoses individuelles, plusieurs prédoses

peuvent être nécessaires pour chaque éprouvette.
7.3 Exigences relatives au contrôle

La conformité aux exigences énoncées en 5.1 et à l'Article 8 doit faire l'objet d'un contrôle visuel.

8 Emballage, marquage et informations à fournir par le fabricant
8.1 Emballage

Les composants du produit doivent être fournis dans des conteneurs convenablement scellés qui protègent

leur contenu de manière appropriée et qui sont sans effet nuisible pour la qualité du produit.

Un emballage externe peut également être utilisé pour présenter les conteneurs individuels sous forme

unitaire.

NOTE Les produits en capsules à pâte unique et liquide/en poudre peuvent être vendus dans un emballage

contenant des doses unitaires de matériau.
4 © ISO 2010 – Tous droits réservés
---------------------- Page: 9 ----------------------
ISO 9917-2:2010(F)
8.2 Marquage et mode d'emploi

Les emballages extérieurs ou les conteneurs doivent comporter des informations détaillées, portées de

manière lisible (pour les emballages multiples à plusieurs doses ou les capsules), selon le cas, et conformes

aux indications du Tableau 2.

Chaque emballage du produit concerné doit être accompagné d'instructions et doit comporter des

informations correspondant au produit (voir Article 4), conformes aux indications du Tableau 2.

Des informations complémentaires à celles spécifiées au Tableau 2 peuvent être fournies à la discrétion du

fabricant.

NOTE Certaines informations y figurent obligatoirement, d'autres étant facultatives. Le symbole «/» signifie que le

sujet en question est sans rapport ou facultatif en ce qui concerne le produit. Le Tableau 2 contient plusieurs références

facultatives et sert de guide au fabricant quant au type d'informations pouvant être utiles aux dentistes.

Tableau 2 — Exigences relatives au marquage et au mode d'emploi
Emballage Emballage Capsule Livret
extérieur externe des (dose d'instructions
Exigence capsules unitaire), du fabricant
voir 3.5
seringues
voir 3.4
ou flacons
a b
1 Nom du produit M M
/ M
2 Identification ou nom du fabricant M M / M
Adresse du fabricant ou de son mandataire
3 M / / M
chargé de la vente
4 Adresse URL / / / /
Informations requises par la réglementation
5 M M / M
locale/nationale
6 Conditions de stockage recommandées M / / M
7 Numéro du lot du fabricant M M / /
Date de péremption, exprimée conformément à
l'ISO 8601, du ciment lorsque celui-ci est
8 M M / /
stocké dans les conditions recommandées par
le fabricant
Durée de conservation dans ces conditions de
9 / / / /
stockage
10 Classification du ciment (voir 4.1) M / / /
11 Application clinique (voir 4.2) / / / M
Nombre de conteneurs/capsules, pour les
12 M M / /
ciments conditionnés en capsules ou prédoses
13 Masse nette de chaque conteneur/capsule / M / M
Teinte et/ou couleur du ciment conformément
14 au nuancier du fabricant (pour produits à / M /
plusieurs teintes seulement)
Si le produit est désigné comme étant opaque,
15 M / / M
une indication claire à cet effet
© ISO 2010 – Tous droits réservés 5
---------------------- Page: 10 ----------------------
ISO 9917-2:2010(F)
Tableau 2 (suite)
Emballage Emballage Capsule Livret
extérieur externe des (dose d'instructions
Exigence capsules unitaire), du fabricant
voir 3.5
seringues
voir 3.4
ou flacons
Si le produit est désigné comme étant radio-
16 opaque (voir 5.6), une indication claire à cet / / / M
effet
Si une déclaration spécifique est faite
concernant le degré de radio-opacité,
17 / / / M
l'épaisseur équivalente d'aluminium pour une
épaisseur de 1 mm du ciment (voir 5.6)
Proportions recommandées des composants
(par exemple poudre/liquide) et instructions
relatives à l'utilisation de tout dispositif aidant à
effectuer le dosage (par exemple des petites
18 / / / M
cuillères, etc.) et proportions poudre/liquide sur
une base masse/masse, avec une exactitude
de 0,1 g. (Pour les produits mélangés
manuellement uniquement)
Vitesse d'incorporation de la poudre dans le
19 liquide. Pour les produits mélangés / / / M
manuellement seulement
Temps de mélange (voir 3.1), s'il est
20 / / / M
nécessaire de réaliser un mélange
État de mélange (s'il y a lieu, état et type de
21 plaque à ciment et de spatule). Pour les / / / M
produits mélangés manuellement seulement
Pour les ciments en capsules, la méthode
22 adoptée pour établir un contact physique entre / / / M
les composants, si nécessaire
Méthode, minutage et type de mélange
23 / / / M
mécanique, si nécessaire
24 Temps de travail (voir 3.2) / / / M
Temps de prise (pour les produits de classes 1
25 / / / M
et 3 uniquement, voir 3.3)
Sources d'énergie extérieures recommandées,
temps d'exposition et toute instruction
26 particulière afférente à l'utilisation du materiel / / / M
(pour les produits de classes 2 et 3
uniquement)
Épaisseur maximale de la couche pour
27 polymérisation [matériaux de classes 2 et 3 / / / M
pour application b) et c) uniquement]
Durée minimale après laquelle on peut
28 commencer la finition et le polissage (pour / / / M
restauration uniquement, voir 4.2)
6 © ISO 2010 – Tous droits réservés
---------------------- Page: 11 ----------------------
ISO 9917-2:2010(F)
Tableau 2 (suite)
Emballage Emballage Capsule Livret
extérieur externe des (dose d'instructions
Exigence capsules unitaire), du fabricant
voir 3.5
seringues
voir 3.4
ou flacons
Méthode de finition recommandée (pour
29 / / / /
restauration uniquement, voir 4.2)
30 Nécessité d'appliquer un vernis, le cas échéant / / / /
Précautions à prendre afin d'éviter l'activation
31 prématurée de la prise (les ciments de / / / M
classes 2 et 3 uniquement)

«/» signifie sans rapport pour cette combinaison conteneur/marquage/instructions ou qu'une telle exigence serait irréalisable ou

impossible ou bien que les informations peuvent être informatives mais facultatives.

«M» indique qu'un élément est obligatoire.

Pour conteneur de dose, individuel ou de petite taille. Les conteneurs individuels doivent permettre l'identification de la

couleur/teinte du matériau, soit directement, soit au moyen d'une référence à une légende ou un guide dans le livret d'instructions.

La désignation opaque peut être incluse dans la teinte.
© ISO 2010 – Tous droits réservés 7
---------------------- Page: 12 ----------------------
ISO 9917-2:2010(F)
Annexe A
(normative)
Détermination du temps de travail et du temps de prise
A.1 Appareillage

A.1.1 Enceinte d'essai, pouvant être maintenue à une température de (37 ± 1) °C et à une humidité

relative d'au moins 50 %.

A.1.2 Pénétrateur, d'une masse donnée, ayant une extrémité plate d'un diamètre donné. La pointe de

l'aiguille doit être cylindrique sur environ 5 mm. L'aiguille doit avoir une extrémité plane et perpendiculaire à

son grand axe.

A.1.2.1 Pénétrateur pour le temps de travail, d'une masse de (28,00 ± 0,25) g et d'un diamètre de

(2,0 ± 0,1) mm.

A.1.2.2 Pénétrateur pour le temps de prise, d'une masse de (400 ± 5) g et d'un diamètre de

(1,0 ± 0,1) mm.

A.1.3 Moule métallique, d'épaisseur (5 ± 2) mm, ayant un trou circulaire ou carré de (10 ± 2) mm de

diamètre et/ou de longueur, découpé dans une tôle de dimensions minimales de 16 mm .

NOTE Les coins intérieurs d'un trou carré peuvent être arrondis.

A.1.4 Bloc métallique, dont l'épaisseur est d'au moins 8 mm et ayant un volume minimal de 60 cm .

A.1.5 Feuille d'aluminium.
A.1.6 Chronomètre, exact à ±1 s.
A.2 Détermination du temps de travail
A.2.1 Mode opératoire

Il convient de manipuler les produits de classes 2 et 3 en l'absence de lumière ayant une longueur d'onde

comprise entre 400 nm et 500 nm, en opérant par exemple dans un local sombre et/ou en lumière filtrée.

L'essai doit être réalisé dans les conditions décrites en 7.1.

Placer le moule métallique (A.1.3), conditionné à (23 ± 1) °C sur le bloc métallique (A.1.4) recouvert de la

feuille d'aluminium (A.1.5), également conditionnée à (23 ± 1) °C et le remplir à ras bord de ciment mélangé.

10 s avant la fin du temps de travail indiqué par le fabricant (voir Tableau 2, point 24) ou la valeur minimale

indiquée dans le Tableau 1 (selon la plus grande des deux valeurs), abaisser avec précaution le

pénétrateur (A.1.2.1) verticalement sur la surface du ciment et l'y laisser 5 s. Noter si le pénétrateur produit

une marque circulaire complète sur la surface du ciment.
Répéter l'essai avec deux mélanges distincts du produit.
8 © ISO 2010 – Tous droits réservés
---------------------- Page: 13 ----------------------
ISO 9917-2:2010(F)
A.2.2 Traitement des résultats

Pour satisfaire aux exigences de l'essai, le pénétrateur doit produire une marque circulaire complète sur la

surface de l'éprouvette de ciment. Les trois valeurs de pénétration doivent être conformes au bout de 10 s

avant le temps de travail indiqué par le fabricant (voir Tableau 2, point 24) et elles doivent être conformes à la

valeur minimale de temps de travail indiqué au Tableau 1.
A.3 Détermination du temps de prise — Produits de classes 1 et 3 uniquement

NOTE Le but du présent essai est de confirmer que la prise peut s'effectuer pour les matériaux de classes 1 et 3 en

l'absence de photo-activation.
A.3.1 Mode opératoire

Placer le moule (A.1.3), conditionné à (23 ± 1) °C, sur la feuille d'aluminium (A.1.5), mélanger ou distribuer le

ciment, mettre en marche le chronomètre (A.1.6) et remplir le moule à ras bord de ciment mélangé.

60 s après la fin du mélange, placer le montage comprenant le moule, la feuille et l'éprouvette de ciment sur

le bloc métallique (A.1.4), dans l'enceinte d'essai (A.1.1). Veiller au bon contact entre le moule, la feuille et le

bloc.

Les produits de classe 3 doivent être soumis à essai en l'absence de photo-activation.

10 s après le temps de prise indiqué par le fabricant (voir Tableau 2, point 25) ou la valeur limite indiquée

dans le Tableau 1 (selon la plus grande des deux valeurs), abaisser avec précaution le pénétrateur (A.1.2.2)

verticalement sur la surface du ciment et l'y laisser 5 s. Retirer le pénétrateur de la surface et noter si celui-ci

cesse de produire une marque circulaire complète dans le ciment, lorsque celle-ci est observée avec un

grossissement ×2.
Répéter l'essai encore deux fois.
A.3.2 Traitement des résultats

Pour satisfaire aux exigences de l'essai, le pénétrateur doit cesser de produire une marque circulaire

complète dans le ciment lors des trois essais. Les matériaux pour lesquels la photo-activation est nécessaire

pour que la prise s'effectue doivent être désignés comme matériaux de classe 2.
© ISO 2010 – Tous droits réservés 9
---------------------- Page: 14 ----------------------
ISO 9917-2:2010(F)
Annexe B
(normative)
Détermination de l'épaisseur du film —
Ciments de scellement uniquement
B.1 Appareillage

B.1.1 Deux plaques de verre, carrées ou circulaires, optiquement planes, transparentes, dont l'aire de la

surface de contact est de (200 ± 25) mm . L'épaisseur de chaque plaque doit être uniforme et ne pas être

inférieure à 5 mm.
B.1.2 Dis
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.