IS/ISO 9917-1: Dentistry - Water-based cement, Part 1: Powder/liquid acid-base cements

28 Pages·2003·9.4 MB·English

by  Bureau of Indian Standards

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IS/ISO 9917-1 (2003): Dentistry - Water-based cement, Part
1: Powder/liquid acid-base cements [MHD 8: Dentistry]
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15/1509917-1 : 2003
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Indian Standard
DENTISTRY - WATER-BASED CEMENTS
PART 1 POWDER/LIQUID ACID-BASE CEMENTS
ICS 11.060.10
© SIS 2008
BUR E A U 0 FIN 0 I A N 5 TAN 0 A R 0'5

MANAK SHAVAN, 9 SAHADUR SHAH ZAFAR MARG
NEW DELHI 110002
July 2008 Price Group 9
Dentistry Sectional Committee, MHR 08
NATIONAL FOREWORD
This Indian Standard (Part 1) which is identical with ISO 9917-1 : 2003 'Dentistry - Water-based
cements - Part 1: Powder/liquid acid-base cements' issued by the International Organization for
Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the
Dentistry Sectional Committee and approval of the Medical Equipment and Hospital Planning Division
Council.
Otherpart of this standard is as follows:
Part 2 Light-activated cements
The text of ISO Standard has been approved as suitable for publication as an Indian Standard without
deviations.Certainconventions are, however, not identical to those used in Indian Standards.Attention
isparticularlydrawn to the following:
a) Whereverthe words 'International Standard'appear referring to this standard, they should
be read as'Indian Standard'.
b) Comma (,) has been used as a decimal marker while in Indian Standards, the current
practice isto use a point (.)as the decimal marker.
Inthisadopted standard, referenceappearstocertain InternationalStandardsfor whichIndianStandards
also exist. The corresponding Indian Standards which are to be substituted in their respective places
are listed below along with theirdegreeof equivalencefor the editions indicated:
International Standard Corresponding Indian Standard Degree of
Equivalence
ISO 7491 : 1985 Dental IS 12181 : 1987 Determination of colour Technically
materials - Determination of stability of dental polymeric materials Equivalent
colour stability
ISO 10993-1:1992 Biological IS 12572 (Part 1) : 1994 Biological Identical
evaluation of medical devices evaluation of medical devices: Part 1
Part 1 :Evaluation and testing Guidance on selection of tests (first
revision)
ISO 3696 : 1987 Water for IS 1070 : 1992 Reagent Grade Water Technically
analytical laboratory use - Specification (third revision) Equivalent
Specification and testmethods
~echnical
!he committee has reviewed the provisions of the following International Standards referred
In this adopted standard, and has decided that they are acceptable for use in conjunction with this
standard:
InternationalStandard
Title
ISO2590 : 1973
Generalmethodforthedeterminationofarsenic- Silverdiethyldithiocarbamate
photometric method
ISO 3665 : 1996
Photography- Intra-oral dental radiographic film - Specification
ISO 7405 : 1997
Dentistry- Preclinicalevaluationof biocompatibilityof medical devices used
in dentistry- Test methods for dental materials
Forthe purposeofdecidingwhetheraparticularrequirementofthis standard is complied with, the final
v~lue,
observedorcalculatedexpressingtheresultofatestoranalysis,shallberoundedoffinaccordance
With.IS 2.: 1960 'Aules for rounding off numerical values (revised)'.The number of significant places
retained Inthe rounded off value should be the same as that of the specified value in this standard.
15IISO 9917-1 :2003
Indian Standard
DENTISTRY - WATER-BASED CEMENTS
PART 1 POWDER/LIQUID ACID-BASE CEMENTS
1 Scope
This part of ISO9917 specifies requirements and test methods for powderlliquid acid-base dental cements
intended for permanent cementation, lining and restoration. Itis applicable to both hand-mixed cements and
encapsulatedcements for mechanicalmixing.Itspecifieslimitsforeachofthepropertiesaccordingtowhether
thecementisintendedfor useasalutingagent,abaseorliner,orarestorative material.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
part of ISO9917, but it is recommended that, in assessing possible biological or toxicological hazards,
reference should be made to ISO7405, Dentistry- Preclinical evaluation of biocompatibility of medical
deviced used in dentistry- Test methods for dental materials, and ISO10993-1, Biological evaluation of
medicaldevices- Part 1:Evaluation andtesting.
2 Normativereferences
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 (includinganyamendments) applies.
ISO2590, General method for the determination of arsenic - Silver diethyldithiocarbamate photometric
method
ISO3665,Photography- Intra-oraldentalradiographicfilm- Specification
ISO3696, Waterforanalyticallaboratory use- Specificationandtestmethods
ISO7491,Dentalmaterials- Determinationofcolourstability
3 Terms anddefinitions
Forthepurposesofthisdocument,thefollowingtermsanddefinitionsapply.
3.1
mixingtime
thatpartoftheworkingtime requiredinordertoobtainasatisfactorymixofthecomponents
3.2

working time
period of time,measured from the start of mixing, during which itis possible to manipulate a dental material
without anadverse effect onitsproperties
ISllSO 9917-1: 2003
3.3
netsettingtime
period of time, measured from the end of mixing, until the material has set according to the criteria and
conditionsspecifiedinAnnexA
NOTE Forthepurposesofthispartof ISO9917, in view of the wide variation in mixingtimes of cements, the net
settingtimeisdeterminedfromtheendofmixing.
.. Classification
4.1 Chemicaltype
Forthe purposesof this part of ISO9917, dental cements shall be classified on the basis of their chemical
composition,asfollows:
a) zincphosphatecement,seeClauseB.1;
b) zincpolycarboxylatecement,seeClauseB.2;
c) glasspolyalkenoatecement,seeClauseB.3.
Acid-basesetting,water-basedcements otherthan those listed above may fall within the scope of this part of
ISO9917. If the manufacturer wishes to claim conformity for a particular product, the manufacturer shall
specifythetypeofmaterialinaccordancewith4.1and4.2sothat the correctperformance limitsareapplied.
4.2 Application
ForthepurposesofthispartofISO9917,materialsshall beclassified onthe basis oftheir usage asfollows:
a) lutingcements;
b) basesorliners;
c) restorativecements.
5 Material
5.1 General
The ce~ent Shall consist of a powder and liquid which, when mixed in accordance with the manufacturer's
Instructions,shallconformwiththerequirements inthis clauseand inClauses 8to 15.
5.2 Components
5.2.1 liquid
:o~non~ncapsu~ated
cements, visually inspect the liquid. It shall be free from deposits or filaments on the
Insideofitscontamer.Thereshallbenovisiblesignsofgelation.
5.2.2 Powder

For non:-encapsulated cements, visually inspect the powder. It shall be free from extraneous material. If the
powderIScoloured,thepigmentshallbeuniformlydispersed throughoutthe powder.
Encapsulatedcementsshallnotbeexaminedinthisway.
2
IsnSO 9917-1 :2003
5.3 Unsetcement
The cement shall bemixed inaccordancewith Clause 6,andthen visually inspected.Itshall behomogeneous
and ofasmooth consistency.
6 Preparation oftestspecimens
6.1 Ambient conditions
Allspecimensshall be prepared at atemperatureof(23±1)·Candarelative humidityof(50±10)%.
6.2 Methodof mixing
The cement shall be prepared in accordance with 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 foreach specimen.
NOTE For encapsulated materials. more than one capsule simultaneously mixed may be required for certain
specimens.
7 Sampling
7.1 Hand-mixedcements
The sample. drawn from one batch, shall provide sufficient material to complete all the prescribed tests and
any necessaryrepeats.
NOTE Approximately509ofpowderisnecessarytocompletethetests.
7.2 Encapsulatedcements
The sample shall comprise aretail package of a sufficient numberof capsules from one batch to complete all
the tests.
8 Net settingtime
When determined in accordance with Annex A, the net setting time of the cement shall conform to relevant
requirementsspecifiedinTable 1.
9 Film thickness (luting cements only)
When determined in accordance with Annex C, the film thickness shall conform to relevant requirements
specifiedinTable 1.
10 Compressive strength
When determined in accordance with Annex D, the compressive strength of the cement shall conform to the

relevantrequirementsspecified inTable 1.
lSIISO 9917-1:2003
11 Acid erosion
Whendeterminedin accordance with Annex E, the acid erosion of the cement shall conform to the relevant
requirementsspecifiedinTable 1.
12 Optical properties (polyalkenoate restorative cements only)
When prepared, stored and tested in accordance with Annex F. cements shall meet the follOWing
requirements:
a) The opacity of the set restorative cement shall be within the limits specified in Table 1, unless the
restorativecementisdesignatedasopaque bythemanufacturer(see Clause 15).
b) Thecolourofthesetcementshallmatch themanufacturer's shade guide.Ifa shade guide isnot supplied
by the manufacturer, then the manufacturer shall nominate a commercially available shade guide [see.
15.3.1c)).
13 Acid-soluble arsenic and lead contents
13.1 Acid-soluble arseniccontent
WhendeterminedinaccordancewithAnnex G,the acid-soluble arseniccontent shall not exceed the relevant
limitsspecifiedinTable 1.
13.2 Acid-soluble leadcontent
When determined in accordance with Annex G, the acid-soluble lead content shall not exceed the relevant
limitsspecifiedinTable 1.
14 Radiopacity
When the manufacturer describes the material as being radiopaque (see 15.2), the radiopacity shall be at
least equivalent to that of the same thickness of aluminium when determined in accordance with Annex H.
When the manufacturer claims a greater radiopacity, the measured value shall not be less than the value
claimedwhendeterminedinaccordancewithAnnexH.
15 Packaging, marking and information to be supplied by manufacturer
NOTE AdditionalinformationmaybeinclUdedatthediscretionofthemanufacturerorasrequiredbylegislation.
15.1 Packaging
~aterials
The shall be supplied in containers or capsules (for the purposes of this part of ISO9917. the
contal~er or capsule shall be considered to be the immediate wrapping of the material) that afford adequate
protectionandhavenoadverse effectonthequalityofthecontents.
An outerpackmayalsobeusedtopresentthecontainers orcapsules as asingle unit.
15IISO 9917·1 :2003
15.2 Marking
Each outer container shall beclearlymarkedwiththefollowingdetails:
a) thename and/ortrademark ofthemanufacturer andthe tradename,typeandapplication ofthecement;
b) theshade ofthepowder accordingtothemanufacturer's nominated shadeguide;
c) the minimum netmass, ingrams, ofthepowder orthe minimum netvolume, inmillilitres,ofthe liquid,as
appropriate;
d) themanufacturer's batchorlotnumber;
e) on the outermost packaging, the recommended conditions of storage, and the "expiry date" for the
material under thoseconditionsofstorage;
f) ifthecementisdesignated opaque,theouterpackaging shallbeclearly markedwiththis information;
g) if the cement is designated as radiopaque, the outer packaging shall be clearly marked with this
information;
h) each outer container of encapsulated cements shall be marked with the number of capsules in the
container, and thenet mass ineach capsule.
15.3 Manufacturer's instructions
15.3.1 General
Instructionsshall accompanyeachpackage ofthematerialandshall includethe following:
a) thetrade name ofthe product;
b) themanufacturer'sname andcontactdetails;
c) a shade guide or, when no shade guide is provided, details of acommercially available shade guide for
usewiththe material.
Inaddition, at least the information in 15.3.2or 15.3.3,asappropriate, shall begiven.For those materials not
mentioned specifically in 4.1, the manufacturer shall indicate the type of material (see 4.1 and 4.2) against
whose performancerequirements thematerialshallbetested.
15.3.2 Hand-mixed cements
Forhand-mixed cements, the following informationshallbesupplied:
a) thetemperaturerange forpreparation;
b) the recommended powder/liquid ratio, expressed as a mass/mass ratio for the recommended
temperature range,and an indication of how the user may achieve this ratio [also. for test purposes, the
powder/liquid ratio on a mass/mass basis to a precision of 0,01g at a temperature of (23±1)·C and a
relative humidityof (50±10)%];
c) thetype of mixing slabandspatulaandtheircondition;
d) therate ofincorporationofthepowder intotheliquid;

e) themixing time (see 3.1);
f) theworking time (see3.2);
5