CONTINUING EDUCATION 2

IN D IR E C T C O M P O S IT E R E S IN R E S T O R A T IO N S

Adhesive Cementation of Indirect Composite

Inlays and Onlays: A Literature Review
C am illo D ’A rcan gelo, DDS; Lorenzo Vanini, MD, DDS; M a tte o Casinelli, DDS; Massimo Frascaria, DDS, PhD;
Francesco De A ngelis, DDS, PhD; Mirco Vadini, DDS, PhD; and M aurizio D ’A m ario, DDS, PhD

L E A R N IN G O B J E C T IV E S

discuss de ntal adhesive

Abstract: The authors conducted a literature review focused on materials and system s fro m b o th a

techniques used in adhesive cementation for indirect composite resin restora­ histo rical and cu rre n t-d a y
pe rsp e ctive
tions. It was based on English language sources and involved a search of online
explain key diffe ren ces
databases in Medline, EMBASE, Cochrane Library, Web of Science, Google b e tw een various adhesive
system s, in clu d in g etch -
Scholar, and Scopus using related topic keywords in different combinations; it
and-rinse, self-etch, and
was supplemented by a traditional search of peer-reviewed journals and cross- self-adhesive

referenced with the articles accessed. The purpose of most research on adhe­ d e scribe th e various
resin cem ent groups
sive systems has been to learn more about increased bond strength and simpli­
acco rd in g to
fied application methods. Adherent surface treatments before cementation are p o ly m e riz a tio n process

necessary to obtain high survival and success rates of indirect composite resin.
Each step of the clinical and laboratory procedures can have an impact on longevity and the esthetic results of
indirect restorations. Cementation seems to be the most critical step, and its long-term success relies on ad­
herence to the clinical protocols. The authors concluded that in terms of survival rate and esthetic long-term
outcomes, indirect composite resin techniques have proven to be clinically acceptable. However, the correct
management of adhesive cementation protocols requires knowledge of adhesive principles and adherence to
the clinical protocol in order to obtain durable bonding between tooth structure and restorative materials.

he proliferation of resin composites and adhesive sys­ issue of marginal infiltration associated with direct techniques, to

T
tems has met the increasing demand for esthetic resto­ date, no method has produced acceptable results . 8-9
rations in both anterior and posterior teeth .1 Depending Posterior indirect restorations are widely used in modern re­
on the respective clinical indication, resin composite storative dentistry to overcome the problems resulting from direct
materials are suitable for both direct and indirect res­ techniques .2 The adhesive concepts that have been used for direct
torations .2 Although direct resin composites have replaced restorative
other procedures are now being applied to indirect restora­
restorative options, there are a number of issues associated with tions and have been incorporated into daily practice .10 Indirect
their use in the posterior region. These include: high polymeriza­ composites offer an esthetic alternative to ceramics for posterior
tion shrinkage; gap formation; poor resistance to wear and tear; teeth . 10-11 The clinical performance of composite resin restora­
color instability; and insufficient mechanical properties . 3 Direct tions is comparable to ceramic restorations, but the relatively low
restorations can result in contact area instability, difficulty in gener­ cost associated with composites has resulted in increased use of
ating proximal contour and contact, lack of marginal integrity, and composite resin-based indirect restorations in the posterior re­
postoperative sensitivity.4 All of these factors impact the longevity gion.12' 14 Ceramic materials exhibit a very high elastic modulus, thus
and clinical success of restorations .5' 7 Despite efforts to reduce the they cannot absorb most of the occlusal forces. Since polymeric

57 0 COMPENDIUM Septem ber 2015 Volume 36, N umber 8

materials absorb a significant amount of occlusal stress, they should
be considered the m aterial of choice.10,15
The success of adhesive restorations depends primarily upon the
luting agent and adhesive system.16Several authors investigated the
properties of resin luting materials such as bond strength, degree of
conversion, and wear, in order to predict their clinical behavior.1722
Among the param eters that may influence the clinical success of
indirect restorations is a proper degree of polymerization of the
resin luting agent, which should be taken into account.23Moreover,
successful adhesion depends on proper treatm ent of the internal
surfaces of the restoration as well as the dentinal surface.2,16
This article discusses materials and techniques used in adhesive
cem entation for indirect composite resin restorations.
The Adhesive Systems
A Historical Overview
Because the microscopic structure of two different contact surfaces
presents irregularities, an adherent is necessary. The introduction
of adhesive materials as alternatives to traditional retentive tech­
niques has greatly revolutionized restorative dentistry.24 In the
development of dental adhesives, the ultim ate goal is to achieve
strong, durable adhesion to dental hard tissues.25 In 1955, Buono-
core showed how the treatm ent of enam el with phosphoric acid
increases the exposed enamel surface by producing m icro-irregu­
larities on it, resulting in improved adhesion potential. The modern
concept of enamel bonding can be traced to his published findings.26
In 1965, Bowen form ulated the first generation of dentinal ad­
hesive.27The increasing interest in adhesion in dentistry led to the
development of four generations of adhesive systems, with the 4th
generation achieving good results for dentin bonding in the 1990s.28
Modern Adhesive Systems
The m odern form ulation of an enam el-dentin adhesive system
includes the following three com ponents29:
• Etchant—an organic acid with the function of dem ineralizing the
surface, dissolving hydroxyapatite crystals, and increasing free
surface energy.
• Primer—an am phiphilic com pound th at increases the w ettabil­
ity of the hydrophilic substrate (dentin) to a hydrophobic agent
(bonding or resin).
• Bonding agent-a fluid resin used to penetrate the etched and primed
substrate and, after curing, to create a real and stable adhesive bond.
In order to obtain an optim al infiltration of enam el and den­
tin substrates, the ideal features of an adhesive m aterial are: low
viscosity; high superficial tension; and effective wettability. The
fundamental requisite is wettability, which depends on the intrinsic
properties of fluid and dental substrate.30
The classification of the respective adhesive systems is based on
their etching characteristics and the num ber of steps they require.31
Etch-and-fiinse Systems—The etch-and-rinse technique is char­
acterized by the etching of the enamel and/or dentin with an acid
agent (orthophosphoric acid at 35% to 37%), which needs to be sub­
sequently washed away. The etch-and-rinse adhesive systems can be
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further classified into three-step and two-step systems. Three-step
systems require separate etching, priming, and bonding. Two-step
adhesives are instead characterized by an application of an etching
compound and then an agent that combines a prim er and a bonding.
The etching application removes the smear plugs, demineralizes the
dentin, and exposes the intertubular dentin collagen fibers, obtaining
an ideal micromechanical anchor for the adhesive.32,33
Self-Etch Systems—Self-etch refers to an adhesive system that
dissolves the smear layer and infiltrates it at the same time, without
a separate etching step.31The self-etch adhesives have been further
classified into two-step systems and one-step systems, which simul­
taneously provide etching, priming, and bonding.34
Self-Adhesive Systems—In the past few years, new resin cements,
so-called “self adhesives,” have been introduced. This particular
resin cem ent needs only to be applied on tooth substrate, w ithout
any etching, priming, or bonding phases.35
Tooth Preparation
After caries and/or failed restoration removal, a cavity with slightly
occlusal divergent walls (5° to 15°) and round internal angles is
prepared by using decreasing grit (from 60-70 pm to 15-20 pm grit)
cylindrical round-ended diamond burs. Preparation margins are not
bevelled but prepared via b u tt joint.2After cavity preparation and
before cavity finishing, adhesive procedures are perform ed36using
a rubber dam in order to achieve an immediate dentin sealing.37,38
In keeping with rubber dam placem ent for subsequent restoration
placement, the interproxim al m argin m ust be supragingival. To
avoid a dual marginal leakage, no direct composite is used for gingi­
val margin rebuilding.39If any deep subgingival margin persists after
cavity preparation-thus precluding proper rubber dam placem ent-
the feasibility of a surgical crown-lengthening procedure and/or an
orthodontic extrusion must be considered.40Alight-curing compos­
ite filling material is used to block out defect-related undercuts.2,41
The finishing phases are performed with diamond burs with a slight
taper and with silicone points (Table 1). The teeth are protected with
tem porary eugenol-free restorations after impression making.42
TABLE 1
Tooth Preparation Phases for
Indirect Composite Resin
T O O T H P R E P A R A T IO N
• D e c re a s in g g r i t ( f r o m 6 0 -7 0 pm to 15-20 pm g r it)
c y lin d r ic a l r o u n d - e n d e d d ia m o n d b u rs
• S lig h tly o c c lu s a l d iv e r g e n t w a lls (5° to 15°)
• R o u n d in te r n a l a n g le s
• B u t t j o i n t p r e p a r a tio n m a r g in s
• Im m e d ia te d e n tin s e a lin g u s in g a d h e s iv e p r o c e d u r e
and ru b b e r dam
• B lo c k in g o u t d e f e c t - r e la te d u n d e r c u ts
• F in is h in g w i t h d ia m o n d b u rs a n d s ilic o n e p o in ts
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Dentin Treatments
Research on adhesive systems is focused mainly on increasing bond
strength and simplifying application. The application of phosphoric
acid increases the surface energy of the dentin by removing the
sm ear layer and prom oting dem ineralization of surface hydroxy­
apatite crystals. T he resin m onom ers, by m eans of th e prim er
agent’s am phiphilic properties, infiltrate the w ater-filled spaces
between collagen fibers, which results in a “hybrid layer” composed
of collagen, resin, residual hydroxyapatite, and traces of water. It
results in an ideal micromechanical anchor substrate for adhesive
systems on dentin.16'43'44
Im m ediate dentin sealing (IDS) is a strategy in which a dentin
bonding agent is applied to freshly cut dentin and polymerized b e­
fore making an impression.45The recommended technique focuses
on the use of the “etch-and-rinse” systems. Etching should extend
slightly over enamel to ensure the conditioning of the entire dentin
surface. The use of either two-step or three-step dentin bonding
agents is equally effective. Self-priming resins, however, generate a
more excess resin layer, which may extend over the margin and re­
quire additional bur corrections. IDS can be immediately followed
by the placement of composite in order to block out eventual under­
cuts and/or build up deep cavities, reducing restoration thickness
and ensuring the light-cured polym erization of the luting agent.
Finally, enam el margins are usually reprepared before final im ­
pression to remove excess adhesive resin and provide ideal taper.45
W hen th e prep aratio n exposes no dentinal areas—eg, in v e­
neered indirect restorations—neither im m ediate dentin sealing
TABLE 2
Suggested Treatment for the Internal
Surfaces of Indirect Restorations
C O M P O S IT E RESTO R A TIO N SURFACE TREATM ENTS
• A cid etch ing
• S andblasting w ith alum inum oxide
• Silane co u pling
• Tribochem ical coa ting
• Laser tre a tm e n t
nor prim er agent applications are necessary, since the etching and
bonding phases ensure an optim al bond for enam el adhesion 46
Im m ediate dentin sealing should be followed by air blocking and
pum icing to generate ideal im pressions 47 In-vitro studies have
shown increased bond strength for IDS versus delayed dentin
sealing (DDS) techniques.48'52The IDS technique also elim inates
any concerns regarding the film thickness of the dentin sealant
and protects dentin against bacterial leakage and sensitivity d u r­
ing th e provisional phase of treatm en t.45 Moreover, it was sug­
gested th a t m ultiple adhesive coatings can improve the quality
of resin-dentin bonds.53
Surface Treatments for Composite Restorations
Several techniques have been suggested for increasing bond
strength, involving treating the internal surfaces of indirect res­
torations (Table 2).54,55 The surface treatm en ts aim not only to
achieve a high retentive bond strength of the restoration, but also
to avoid any microbiological leakage.56 Composite surface tre a t­
m ents are necessary for adhesion of indirect com posite resto ra­
tions.57Acid-etching w ith phosphoric acid, acidulated phosphate
fluoride, or hydrofluoric (HF) acid is one of the treatm ents reported
in literature.58'60
T he in te rn al surfaces of indirect resto ratio n s can be abrad­
ed w ith alum inium oxide, using an in trao ral sandblasting d e­
vice.58,59,61'63Also, silane coupling agents are used as adhesion pro­
moters.64,65A nother m ethod, the tribochem ical coating, forms a
silica-modified surface as a result of airborne-particle abrasion
w ith silicon dioxide (S i0 2)-coated alum inium particles. The sur­
face becomes chemically reactive to th e resin by means of silane
coupling agents.63,66,67
M any studies show th a t EriYAG laser tre a tm e n t enhances
bond strength betw een com posite and resin cem ent.68,69 O ther
studies d em o n strate no influence of laser tre a tm e n t on bond
strength.67,70
R oughening th e com posite area of adhesion, sandblasting,
o r b o th san d b lastin g and silanizing can provide statistically
significant additional resistance to ten sile load. A cid-etching
w ith silane tre a tm e n t does n o t reveal significant changes in
tensile bond strength. Sandblasting tre a tm e n t is th e m ain fac­
to r responsible in improving the retentive properties of indirect
com posite resto ratio n s.57

TABLE 3

Recommended Clinical Protocol, According to Review Outcomes

D E N T IN SURFACE C O M P O S IT E SURFACE C E M E N TA TIO N

TREATM ENT TR EA TM EN T

Im m ediate de n tin sealing S oft-san dblastin g
using a three-step, to ta l- (50 pm A I2 0 3 using
etch d e n tin -b o n d in g ag e n t an intraoral sandblast-
w ith a fille d adhesive resin ing device a t 2 bar
and ru b b e r dam isolation pressure) abrasion o f
the co m p o site internal
surfaces
• C o nstan tly using ru b b e r dam isolation w ith three-step,
to ta l-e tc h , lig h t-c u re d cem e nt system
• P reheating th e lig h t-cu re d co m p o site resin cem ent
• Rem oving residual cem ent using explorer, scalpels,
and floss be fore co m p le te p o lym e riza tio n and 15c
scalpel a fte r po lym e riza tio n

572 COMPENDIUM September 2015 Volume 36, Number 8

 Cementation
Resin cements are divided into three groups according to polym­
erization process: chemically activated cements, light-cured ce­
ments, and dual-cured cements.1671Of the three, light-cured resin
cements have the clinical advantages of longer working time and
better color stability, but curing time, restoration thickness, and
overlay material significantly influence the microhardness of the
resin composites employed as luting agents.4672
Dual-cured resin cements have the advantages of controlled
working time and adequate polymerization in areas that are inac­
cessible to light. Conversely, they are relatively difficult to han­
dle.23,73'74 Photoactivation increases the degree of conversion and
surface hardness of dual-cured cements.75
Optimal luting of indirect restorations is dependent on the light
source power, irradiation time, and dual-cure luting cement or
light-curing composite chosen. Curing should be calibrated for
each material to address high degrees of conversion. Preheating
light-cured filled composites allows the materials to reach optimal
F ig 1. A m a n d ib u la r firs t molar, w ith a fra c tu re d c o m p o s ite re sto ra tio n : c a v ity p reparation . F ig 2 . Im m ediate d e n tin sealing. F ig 3. C e m e n ta tio n o f
an in d ire c t c o m p o s ite re stora tion. F ig 4 . P ostop era tive view.
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fluidity.7678 The suggested temperature for composite preheating
is 39°C.79The necessary working time for positioning the indirect
restorations and removing the excess cement can be extended at
the discretion of the clinician, using a light-curing composite as
luting agent, thus overcoming the relatively restricted working
time allowed by dual-cure cements.2
Total-etching of dentin substrate is recommended as the first
step for the two- and three-step adhesive systems.80To reduce the
number of operative steps and to simplify the clinical procedures,
self-etching adhesive systems, which do not require a separate
acid-etching step, have been introduced.81Literature reports dem­
onstrate that multi-bottle systems with simultaneous etching and
rinsing show superior in-vitro and in-vivo activities compared to
the new all-in-one systems.44'82
The self-adhesive resins may be considered an alternative for
luting indirect composite restorations onto non-pretreated dentin
surfaces,83 even if bond strengths are lower than etch-and-rinse
systems.8485The etch-and-rinse technique provides more reliable
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bonding com pared to self-etch luting agents and self-adhesive An appropriate treatm en t of the fitting surface of the resin com ­
luting agents when used to bond indirect composite restorations posite restoration and dentin substrate is necessary to establish
to dentin.22,86"88 a strong and durable bond.57
The constant use of rubber dam isolation is necessary for the 11 is recommended th at the freshly cut dentin surfaces be sealed
cem entation protocol with adhesive systems. Removing residual with a dentin bonding agent imm ediately following tooth prepa­
cem ent using explorers, scalpels, and floss before complete polym­ ration, before taking impression.45 Im m ediate dentin sealing re­
erization, and a 15c scalpel after polymerization, is recommended sults in a high bond strength for total-etch and self-etch adhesives;
in order to avoid com prom ising restoration m arginal accuracy, however, the microleakage is sim ilar to th a t w ith conventional
com pared to the use of burs, discs, or strips (Table 3).2 cem entation techniques.49
W hen following a protocol of cem en tatio n using an adhesive
Discussion and Conclusions system, constant rubber dam isolation and careful hand finish­
R esin-based com posites give predictable results in te e th res­ ing are necessary to provide predictable clinical results (Figure
toration w ith respect to both mechanical and 1 through F igure 4).a
esthetic properties w hen they are used as indi­ Supragingival margins facilitate impression
rect restoration materials.2 Indirect composites Resin cem ents are making, definitive restoration placement, and
make it possible to overcome some shortcom ­ divided into three detection of secondary caries.94 In addition,
ings of direct techniques. Indirect restorations— some studies have dem onstrated th a t subgin­
ie, those created outside of the m outh—result
groups according to gival restorations are associated w ith higher
in b etter proximal and occlusal contacts, better polym erization levels of gingival bleeding, attachm ent loss, and
w ear and marginal leakage resistance, and en­ gingival recession than supragingival resto ra­
hancem ent of mechanical properties compared
process: chem ically tions.95,96 Therefore, in all cases where rubber
to direct techniques.6,85 activated cements, dam can n o t be adequately placed, surgical
Since the dentin substrate has a high organic crown lengthening or orthodontic extrusion
content, tubular structure variations, and the
light-cured cements, should be taken into account. Otherwise, tr a ­
presence of outward fluid movement, bonding and dual-cured ditionally cemented restorations are preferable
to dentin is a less reliable technique when com ­ to the use of adhesive procedures.
pared to enamel bonding.89,90Bonding composite cements. Sandblasting of the composite surfaces has
restorations to tooth structure involves the den- been recommended as a predictable means for
tin/adhesive-cem ent interface and com posite enhancing the retention between resin cements
restorations/ cem ent interface.22 and indirect composite restorations.57,97The ap­
Each step of the clinical and laboratory procedures can have plication of an appropriately selected adhesive material with proper
an impact on the esthetic results and longevity of indirect resto­ technique will ensure predictable results and successful long-term
rations.91 C em entation is the most critical step and involves the clinical outcomes.
application of both the adhesive system and resin luting agent.92,93 Modified United States Public H ealth Service criteria are the
most complete and commonly used assessment techniques in clini­
Fig 5. cal trials on indirect composite restorations.37,98
D’Arcangelo, et al, 20142 ■ Manhart, et al, 2001100
X Barone, et al, 2008 6 • Leirskar, et al, 1999 101 As shown in Figure 5, restorations were evaluated at baseline and
A Huth, et al, 2011 99 + Scheibenbogen-Fuchsbrunner, et al, 1999102 after a follow-up period for secondary caries, marginal adaptation,
marginal discoloration, color match, anatomic form, surface rough­
100
ness, endodontic complications, fracture of the restoration, fracture
90 ----- ID- of the tooth, and retention of the restoration.2,6,99 102In m any of the
80 reported follow-up studies, indirect restorative procedures were
70 carried out by dental students,99"102 and the main reasons for fail­
60 ures during the observation period seemed to be secondary caries,
50
endodontic complications, and fractures.1,2
T he literatu re sources su p p o rt th e clinical acceptability of
40
indirect composite resin techniques regarding survival rate and
30
esthetic outcomes at up to 10 years’ follow-up.1,103Adhesive cem en­
20 tation is a complex procedure that requires knowledge of adhesive
10 principles and adherence to the clinical protocol in order to obtain
0% durable bonding between tooth structure and restorative material.
24 m onths 36 months 4 8 months 6 0 months

DISCLOSURE
Fig 5. S urvival rate o f in d ire c t c o m p o s ite re stora tions re p o rte d in
references 2, 6, 99-102. The survival rate (%) is calcu la te d c o n sid erin g
th e USPHS criteria. The authors had no disclosures to report.

574 COMPENDIUM Septem ber 2015 Volume 36, N umber 8

 ABOUT THE AUTHORS
Camillo D’Arcangelo, DDS
Department of Restorative Dentistry, School of Dentistry, University G. D’Annunzio -
Chieti, Italy
Lorenzo Vanini, MD, DDS
Private Practice, Chiasso, Switzerland
Mutteo Casinelli, DDS
Unit of Restorative Dentistry, Department of Life, Health and Environmental
Sciences, School of Dentistry, University of LAquila, LAquila, Italy
Massimo Frascaria, DDS, PhD
Unit o f Restorative Dentistry, Department of Life, Health and Environmental
Sciences, School of Dentistry, University of LAquila, LAquila, Italy
Francesco De Angelis, DDS, PhD
Department of Restorative Dentistry, School of Dentistry, University G. D’Annunzio -
Chieti, Italy
Mirco Vadini, DDS, PhD
Department of Restorative Dentistry, School of Dentistry, University G. D’Annunzio -
Chieti, Italy
Maurizio DAmario, DDS, PhD
Unit of Restorative Dentistry, Department of Life, Health and Environmental
Sciences, School of Dentistry, University of LAquila, LAquila, Italy
Queries to the author regarding this course may be submitted to
authorqueries@aegiscomm.com.
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QUIZ

Adhesive Cementation of Indirect Composite Inlays and Onlays: A Literature Review

C a m illo D’A rcan ge lo, DDS; Lorenzo Vanini, MD, DDS; M atteo C asinelli, DDS; Massimo Frascaria, DDS, PhD;
Francesco De A ngelis, DDS, PhD; M irco Vadini, DDS, PhD; and M aurizio D’A m ario, DDS, PhD

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1. Issues associated with the use of direct resin composites in the 6. After cavity preparation and before cavity finishing, adhesive
posterior region include: procedures are performed using a rubber dam in order to:
A. high p o ly m e riz a tio n shrinkage. A. decrease g rit.
B. ga p fo rm a tio n . B. achieve an im m e d ia te d e n tin sealing.
C. c o lo r instability. C. expose in te rtu b u la r d e n tin collagen fibers.
D. all o f th e above D. dissolve th e h y b rid layer.

2. While the clinical performance of composite resin restorations is 7. The application of phosphoric acid increases the surface
comparable to ceramic restorations, increased use of composite energy of dentin by removing the what and promoting
resin-based indirect restorations in the posterior region is a demineralization of surface hydroxyapatite crystals?
result of: A. collag en fibe rs
A. c o m p o s ite s ’ exce lle nt resistance to w ear and tear. B. trib o c h e m ic a l co a tin g
B. co m p o site s' s up erb m a rgina l inte grity. C. h yb rid layer
C. th e re la tively low co st associated w ith com posites. D. sm ear layer
D. a lack o f po s to p e ra tiv e s e n s itiv ity associated w ith com posites.
8. Immediate dentin sealing (IDS) is a strategy in which a dentin
3. An adherent is necessary because the microscopic structure of bonding agent is applied to freshly cut dentin and
two different contact surfaces presents: polymerized before:
A. irre gula rities. A. caries rem oval.
B. ro und inte rnal angles. B. m aking an im pression.
C. a clean, s m o o th surface. C. m a rgin preparation .
D. a b u tt jo in t. D. laser tre a tm e n t.

4. What is an organic acid that demineralizes the surface, dissolves 9. What is the main factor responsible in improving the retentive
hydroxyapatite crystals, and increases free surface energy? properties of indirect composite restorations?
A. p rim e r A. sa n dblastin g tre a tm e n t
B. b o n d in g a g e n t B. a cid -e tch in g
C. e tc h a n t C. silaniza tion
D. lig h t-c u re d c o m p o s ite fillin g m aterial D. pu m icing

5. What refers to an adhesive system that dissolves the smear layer and 10. Light-cured filled composites can reach optimal fluidity by
infiltrates it at the same time, without a separate etching step? doing what to them?
A. self-etch A. e tch in g and rinsing the m
B. self-adhesive B. isolatin g the m
C. etch -a n d -rin se C. p re hea ting the m
D. se le ctive -e tch D. air b lo ckin g the m

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578 COMPENDIUM September 2015 Volume 36, Number 8

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idsimpiants.com
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580 COMPENDIUM September 2015 Volume 36, Number 8

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idsimplants.com —
IfjQ integrated dental systems 300 Sylvan Ave.. Suite 104, Englewood Cliffs. N.J. 07632 ISO 9001 : 2000
I More for you. More for your patients. 866-277-5662 • 201-676-2456 ISO 13485 : 2003
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