ISO 16443:2014
(Main)Dentistry — Vocabulary for dental implants systems and related procedure
Dentistry — Vocabulary for dental implants systems and related procedure
ISO 16443:2014 specifies terms and definitions for dental implants and for instruments, accessories, and the most commonly used clinical terms related to implant systems and procedures in dentistry. Grafting materials and membranes are excluded from ISO 16443:2014. The following devices are also excluded from the scope of ISO 16443:2014. Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to provide anchorage for an epithesis (to replace for example: ears, noses and parts of eyes and orbital regions): epithesis implant; craniofacial implant; maxillofacial implant. Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to provide anchorage for an orthodontic appliance: orthodontic implant.
Médecine bucco-dentaire — Vocabulaire des systèmes d'implants dentaires et procédures associées
L'ISO 16443:2014 spécifie les termes et définitions relatifs aux implants dentaires, aux instruments et aux accessoires, ainsi que les termes cliniques les plus couramment employés en médecine bucco-dentaire dans le domaine des procédures et des systèmes implantaires. Les matériaux de greffe osseuse et les membranes ne sont pas traités dans l'ISO 16443:2014. Les dispositifs suivants ne relèvent pas non plus du domaine d'application de l'ISO 16443:2014. Les dispositifs spécialement conçus pour être placés à l'intérieur, au travers ou à la surface des os du complexe cranio-facial, dont le but principal est de servir d'ancrage à une épithèse (pour remplacer par exemple les oreilles, le nez et certaines parties des yeux et des régions orbitales): implant pour épithèse; implant cranio-facial; implant maxillo-facial. Les dispositifs spécialement conçus pour être placés à l'intérieur, au travers ou à la surface des os du complexe cranio-facial, dont le but principal est de servir d'ancrage à un appareil orthodontique: implant orthodontique.
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 16443
NORME
First edition
Première édition
INTERNATIONALE 2014-07-15
Dentistry — Vocabulary for dental
implants systems and related
procedure
Médecine bucco-dentaire — Vocabulaire des systèmes d’implants
dentaires et procédures associées
Reference number
Numéro de référence
ISO 16443:2014(E/F)
©
ISO 2014
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ISO 16443:2014(E/F)
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ISO 16443:2014(E/F)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions related on medical devices used in oral implantology .1
3.1 Dental implant . 1
3.2 Dental implant system . 2
3.3 Ancillary devices used in oral implantology. 6
4 Terms and definitions related to clinical and surgical concepts used in oral implantology .8
Bibliography .12
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ISO 16443:2014(E/F)
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
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. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 3, Terminology.
ISO is now publishing all its standards using a processing system that allows the production of
International Standards as XML files. With this new system, the terms and definitions from terminologies
and vocabularies are stored in the Online Browsing Platform (OBP) (www.iso.org/obp) where they can
be browsed free of charge by members of the public (but not downloaded).
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ISO 16443:2014(E/F)
Introduction
This terminology international standard has been prepared and is presented accordingly with
recommendations provided in
ISO 704, Terminology work — Principles and methods,
ISO 860, Terminology work — Harmonization of concepts and terms,
ISO 1087-1, Terminology work — Vocabulary — Part 1: Theory and application, and
ISO 10241-1, Terminological entries in standards — Part 1: General requirements and examples of
presentation.
Accordingly to ISO directives, ISO 704 and ISO 1087, this standard has been prepared and is presented
in a systematic approach. The systematic approach presents the advantage of being independent from
language, therefore allowing the same logical numbering in any language.
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INTERNATIONAL STANDARD ISO 16443:2014(E/F)
Dentistry — Vocabulary for dental implants systems and
related procedure
1 Scope
This International Standard specifies terms and definitions for dental implants and for instruments,
accessories, and the most commonly used clinical terms related to implant systems and procedures in
dentistry. Grafting materials and membranes are excluded from this International Standard.
The following devices are also excluded from the scope of this International Standard.
Device specially designed to be placed within, through or upon the bones of the cranio-facial complex,
the primary purpose of which is to provide anchorage for an epithesis (to replace for example: ears,
noses and parts of eyes and orbital regions):
— epithesis implant;
— craniofacial implant;
— maxillofacial implant.
Device specially designed to be placed within, through or upon the bones of the cranio-facial complex,
the primary purpose of which is to provide anchorage for an orthodontic appliance:
1)
— orthodontic implant .
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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
NOTE Except for the following terminological entries that supersede ISO 1942:2009, the terms and definitions
given in ISO 1942 apply for the purpose of this document.
3 Terms and definitions related on medical devices used in oral implantology
For the purposes of this document, the following terms and definitions apply.
3.1 Dental implant
3.1.1
dental implant
device especially designed to be placed within, through or upon the bones of the cranio-facial complex,
the primary purposes of which are to support and/or to resist displacement of a dental prosthesis
3.1.1.1
endosseous dental implant
endosteal implant (DEPRECATED)
dental implant (3.1.1) placed partially or entirely within the bone
1) This definition supersedes the one given in ISO 1942.
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ISO 16443:2014(E/F)
3.1.1.2
interim endosseous dental implant
provisional implant
endosseous dental implant (3.1.1.1) for temporary usage
3.1.1.3
transendodontic implant
endodontic endosseous implant
transradicular implant (DEPRECATED)
rod, specially made to be inserted longitudinally either through a root canal or through a root segment
which extends through the apex into the surrounding bone to stabilize a tooth
3.1.1.4
intramucosal implant
oral mucosal insert
submucosal implant (DEPRECATED)
button implant (DEPRECATED)
dental implant (3.1.1) placed in the soft tissue lining of the oral cavity
3.1.1.5
ramus endosseous implant
ramus endosteal implant (DEPRECATED)
dental implant (3.1.1) placed within the ramus of the mandible
3.1.1.6
frame implant
ramus frame endosteal implant (DEPRECATED)
One-piece implant consisting of a number of mandibular subperiosteal and/or endosseous components
linked with an intra-oral structure
3.1.1.7
subperiosteal dental implant
subperiosteal implant abutment (DEPRECATED)
dental implant (3.1.1) that is placed beneath the periosteum and overlying the bony cortex
3.1.1.8
transmandibular implant
dental implant (3.1.1) consisting of a plate and posts designed so that the posts can be placed to extend
vertically from the inferior border of the mandible through the plate, bone and mucosa and into the oral
cavity in the anterior region
3.1.1.9
zygoma implant
dental implant (3.1.1) intended to be partially inserted into or on the zygomatic bone
3.2 Dental implant system
3.2.1
dental implant system
implant kit
implant system
integrated system of components, specific equipment and ancillary instruments necessary for the
clinical and laboratory procedures required for the placement of the dental implant (3.1.1) and the
construction and insertion of an implant-supported dental prosthesis
3.2.2
implant component
element of a dental implant system (3.2.1)
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ISO 16443:2014(E/F)
3.2.3
dental implant assembly
assembly of dental implant components (3.2.2) as recommended by the manufacturer(s) to serve the
purposes of a dental implant (3.1.1)
3.2.4
implant body
dental implant body
implant fixture (DEPRECATED)
endosteal implant body (DEPRECATED)
primary single component or portion of a dental implant (3.1.1) which is intended to remain within the
hard and soft tissues and can be totally or partially submerged by soft tissue
3.2.4.1
implant body endosseous zone
portion of the implant body (3.2.4) which is intended for intra-bone positioning
3.2.5
transmucosal component
part of a dental implant system (3.2.1) that passes through the mucosa
3.2.6
tissue interface surface
implant contact surface
surface of an implant body (3.2.4) or implant component (3.2.2) intended to contact the patient’s tissues
3.2.7
tissue interface surface treatment
modification of a dental implant component (3.2.2) surface by subtraction or addition of material
3.2.7.1
implant component coating
implant component (3.2.2) surface treatment by addition
3.2.8
connecting interface
implant connective platform
portion of a dental implant body (3.2.4) or implant component (3.2.2) intended to connect with another
implant component (3.2.2)
3.2.8.1
platform switching design
connecting interface (3.2.8) designed to allow the use of implant abutments (3.2.10) with diameters less
than that of the implant body (3.2.4)
3.2.9
anti-rotation feature
design of the connecting interface (3.2.8), that prevents rotation of the connected implant component
(3.2.2) around the central long axis of the implant body (3.2.4)
3.2.9.1
external anti-rotation feature
anti-rotation feature (3.2.9) extending outside the implant body (3.2.4)
3.2.9.2
internal anti-rotation feature
anti-rotation feature (3.2.9) shaped within the implant body (3.2.4)
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ISO 16443:2014(E/F)
3.2.10
implant abutment
implant component (3.2.2) connected to the implant body (3.2.4) or implant connecting part (3.2.11),
which serves as an abutment
3.2.10.1
straight implant abutment
non-angulated implant abutment
non-angled implant abutment
implant abutment (3.2.10) having central long axis coincident with that of the implant body (3.2.4)
3.2.10.2
angulated implant abutment
angled abutment
implant abutment (3.2.10) having a principal long axis divergent from the central long axis of the implant
body (3.2.4)
3.2.10.3
castable implant abutment
castable abutment
prefabricated implant abutment (3.2.10) intended to be customized and used for casting
3.2.10.4
partially castable implant abutment
partially castable abutment
UCLA abutment (DEPRECATED)
prefabricated implant abutment (3.2.10) intended to be customized and cast except for the connecting
interface (3.2.8)
3.2.10.5
preparable abutment
milling abutment
implant abutment (3.2.10) intended to be customized in its shape or form by a milling process
3.2.10.6
CAD/CAM abutment
patient specific implant abutment (3.2.10) designed and fabricated using the CAD/CAM process
3.2.10.7
implant ball abutment
ball abutment
implant abutment that serves as a prosthetic attachment
3.2.10.8
implant magnetic abutment
magnetic abutment
implant abutment (3.2.10) that serves as a magnetic prosthetic attachment
3.2.11
implant connecting part
dental implant connecting part
implant component (3.2.2) used between the implant body (3.2.4) and the implant abutment (3.2.10)
3.2.12
monopart implant
monotype implant
one-piece implant
1-piece implant
endosseous dental implant (3.1.1.1) made in one piece that consists of the implant body (3.2.4) part and
an implant abutment (3.2.10)
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ISO 16443:2014(E/F)
3.2.13
two part implant
two piece implant
2-piece implant
endosseous dental implant (3.1.1.1) consisting of an implant body (3.2.4) to which is connected an implant
abutment (3.2.10) or a dental prosthesis
3.2.14
multi-part implant
two parts implant (3.2.13) with the addition of one or more implant connecting parts (3.2.11)
3.2.15
implant cover screw
cover screw
implant component (3.2.2) used in phase one or placement surgery to prevent tissue growth within the
connecting interface (3.2.8) of an implant body (3.2.4)
3.2.16
transmucosal healing component
transmucosal forming component
implant healing abutment
implant component (3.2.2) that projects into the oral cavity and is used for a limited time to guide healing
of the surrounding soft tissues
3.2.17
abutment screw
centre screw (DEPRECATED)
implant component (3.2.2) used to attach an implant abutment (3.2.10) to an implant body (3.2.4)
3.2.18
prosthetic screw
horizontal screw
occlusal screw
implant component (3.2.2) screw which fixes the implant superstructure (4.23.1) to the implant body
(3.2.4), implant connecting part (3.2.11) or implant abutment (3.2.10)
3.2.19
implant connecting part screw
implant component (3.2.2) which fixes an implant connecting part (3.2.11) to an implant body (3.2.4)
3.2.20
implant analogue GB
implant analog US
implant laboratory replica
implant component (3.2.2) intended for inclusion in a working model or cast to replicate the connecting
interface (3.2.8) of an implant body (3.2.4) or implant component (3.2.2) for laboratory procedures
3.2.21
implant impression coping
implant impression cap
implant transfer post
implant impression post
implant component (3.2.2) used to transfer the position of the connecting interface (3.2.8) to the working
cast/model by means of an impression
3.2.22
abutment analog
implant component (3.2.2) directly connected to the implant laboratory replica (3.2.20) and used only
for the preparation of the implant superstructure (4.23.1) in the dental laboratory and not intended for
clinical use
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ISO 16443:2014(E/F)
3.3 Ancillary devices used in oral implantology
3.3.1
implant screwdriver
tool for tightening and/or removing (loosening) screws that connect implant components (3.2.2) and/or
dental prosthesis
3.3.2
bone thread cutter
bone tap
bone thread former
instrument for preparation of athread in the prepared implant osteotomy site (4.6)
3.3.3
profile drill
stepped drill
calibrated rotary instrument for preparation of the implant osteotomy site (4.6) in various shapes and
lengths, so as to precisely fit the implant body (3.2.4)
3.3.4
implant insertion preassembled device
insertion transfer device
fixture mount (DEPRECATED)
device to which an implant body (3.2.4) may be temporarily secured to facilitate its placement in the
prepared osteotomy site
3.3.5
holding bar
holding key
device designed to hold the implant body (3.2.4) in the planned position during placement
3.3.6
pilot drill
rotary instrument used to prepare a preliminary hole for the implant osteotomy site (4.6)
3.3.7
abutment finisher
crown base finisher
finishing instrument for planned removal of oxide layers on the implant abutment (3.2.10)
3.3.8
tissue punch
rotary tissue punch
soft tissue trepan
central knife
instrument for removal of a disc of soft tissue
3.3.9
ratchet wrench
force transferring instrument, used for preparation of the implant osteotomy site or the insertion of the
implant body (3.2.4) or as a holder for the implant screwdriver (3.3.1)
3.3.10
torque wrench
ratchet wrench (3.3.9) with a measurable torque and/or torque limitation
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ISO 16443:2014(E/F)
3.3.11
ratchet wrench insert
applicator
torque wrench adapter
ratchet adapter
device inserted into the wrench or the torque wrench (3.3.10) to connect with the rotated tool or implant
body (3.2.4)
3.3.12
implant mallet
mallet for insertion of an impacted implant body (3.2.4)
3.3.13
insertion instrument
impact transferring device
mallet force transferring device
instrument for transferring the force between implant mallet (3.3.12) and impacted implant body (3.2.4)
3.3.14
paralleling device
alignment pin
graduated rod inserted in the implant socket (4.6) during its preparation so as to aid in its orientation
and depth
3.3.15
template
physical or virtual artefact fabricated to aid in the planning and/or treatment of a patient with a dental
implant (3.1.1) or implants
3.3.15.1
measuring template
measuring foil
transparency with pictures of the implant body (3.2.4) in various sizes according to radiographic
magnifications for selection, on the patient’s radiographs, of the proper implant dimension
3.3.15.2
radiographic guide
template (3.3.15) designed to optimize linear measurement on a radiographic image
3.3.15.3
surgical template
surgical guide
drill template
template (3.3.15) designed to assist a clinician in optimising the position(s)of the implant(s) in their
surgical implant site(s) during dental implant surgery (4.5)
3.3.15.4
CAD/CAM template
template (3.3.15), fabricated by technology which involves the use of digitalized data in design and
fabrication
3.3.15.5
bur sleeve
drill sleeve
drill tube
bur tube
sleeve embedded in a surgical template (3.3.15.3) for the purpose of guiding the drill during dental
implant surgery (4.5)
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ISO 16443:2014(E/F)
4 Terms and definitions related to clinical and surgical concepts used in oral
implantology
4.1
oral implantology
dental implantology
dental treatment modality concerned with the study and the utilization of dental implants (3.1.1)
4.2
biointegration
persistence of a biomaterial implanted in a living tissue, without unacceptable adverse effect
4.3
osseointegration
osteointegration
retention of an implant body (3.2.4) by direct contact of living bone cells visible at the light microscope
level
4.4
dental implant biointegration
osseointegration (4.3) and/or biointegration (4.2) of a dental implant (3.1.1) in the tissues
4.5
dental implant surgery
surgical placement of dental implant (3.1.1) and associated materials such as bone grafting materials or
membrane
4.6
implant socket
implant osteotomy site
cavity prepared in the bone to host the implant body (3.2.4)
4.7
immediate implantation
direct implantation
dental implant surgery (4.5) immediately or until 48 h after tooth loss
4.8
delayed immediate implantation
dental implant surgery (4.5) in the still existing residual part of the dental alveoli and after 48 h up to six
months after tooth loss
4.9
delayed implantation
dental implant surgery (4.5) in a bone with no residual alveoli, or more than 6 months after tooth loss
4.10
replacement implantation
dental implant surgery (4.5) to replace a lost dental implant (3.1.1) in the same location
4.11
transosteal
a procedure involving penetration of both the external and directly opposing internal cortical bone
plates
4.12
fully embedded implant
dental implant body (3.2.4) that is fully inserted inside the bone and covered by soft tissue
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ISO 16443:2014(E/F)
4.12.1
two stage procedure
dental implant surgery (4.5) to place a fully embedded implant (4.12), needing a later surgery to uncover it
4.12.2
second stage implant surgery
operation used in a two stage procedure (4.12.1) to uncover an implant body (3.2.4) in preparation for
connecting the implant body (3.2.4) to an added dental implant component (3.2.2)
4.13
single stage procedure
dental implant surgery (4.5) where the dental implant (3.1.1) projects into the oral cavity immediately
after placement
4.14
countersink
modification of the bone at the implant site to accommodate the cervical shape of a dental implant (3.1.1)
4.15
closed healing
process of healing when the implant body (3.2.4) is not exposed to the oral cavity
4.16
open healing
process of healing when the implant body (3.2.4) is exposed to the oral cavity
4.17
primary stability
initial stability
mechanical stability
absence of significant movement of the implant body (3.2.4) determined at the clinical level immediately
after insertion
4.18
secondary stability
biological stability
secondary fixation
absence of detectable movement of the implant body (3.2.4) determined at the clinical level after the
healing period
4.19
peri-implantitis
inflammation of the tissues adjacent to a dental implant (3.1.1), including the bone, at the protrusion of
the implant through the mucosa
4.20
peri-implant mucositis
inflammation of the mucosa at the protrusion of a dental implant (3.1.1) through the mucosa
4.21
endosteal peri-implantitis
bone inflammation around the implant body (3.2.4)
4.22
peri-implant tissue management
treatment of the bone and/or mucosa surrounding the dental implant (3.1.1) for aesthetic or functional
purposes
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ISO 16443:2014(E/F)
4.22.1
bone augmentation
oral surgery procedure of using grafting materials to increase the osseous volume of a portion of a
mandibular or maxillary alveolar ridge or other adjacent osseous structures
4.22.2
crestal sinus lift
internal sinus lift
bone augmentation (4.22.1) underneath the sinus membrane through the dental implant (3.1.1) borehole
4.22.3
lateral sinus lift
external sinus lift
bone augmentation (4.22.1) underneath the sinus membrane through a vestibular access
4.22.4
bone packing
bone augmentation (4.22.1) within an intrabony cavity
4.22.5
bone spreading
bone expanding
bone augmentation (4.22.1) on the outer surface of the bone
4.22.6
bone splitting
surgical horizontal bone expansion by dividing the opposing bone plates from the cervical to the apical
direction to allow augmentation and dental implant placement
4.22.7
alveolar ridge distraction
distraction bone generation
distraction
distraction osteogenesis
continuous, instrument guided separation of intentionally fractured bone segments, with the intention
to increase the vertical jaw bone height
4.22.8
bone condensing
compression of bone in the implant site in order to increase bone density
4.23
implant prosthetics
prosthodontic restoration of oral function in an implant patient including treatment planning, prosthesis
design and fabrication
4.23.1
implant superstructure
single or multiple layer structure connected to dental implant(s) (3.1.1) to restore the function of missing
tissues
Note 1 to entry: This excludes dental implant abutments (3.2.10).
4.23.2
implant loading
exposure of a dental implant (3.1.1) to partial or full functional stress
4.23.3
immediate loading
direct loading
implant loading within a maximum of 72 hours after the placement of the dental implant (3.1.1)
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ISO 16443:2014(E/F)
4.23.4
progressive loading
gradual increase of implant loading (4.23.2)
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ISO 16443:2014(E/F)
Bibliography
[1] DIN 13902-1, Zahnheikunde — Terminologie der oralen Implantology — Teil 1: Enossale dentale
Implantatsysteme
[2] DIN 13902-2, Zahnheikunde — Terminologie der oralen Implantology — Teil 2: Instrumente und
zahntechnische Hilfsteile
[3] DIN 13902-3, Zahnheikunde — Terminologie der oralen Implantology — Teil 3: Klinische Begriffe
[4] ISO 704, Terminology work — Principles and methods
[5] ISO 860, Terminology work — Harmonization of concepts and terms
[6] ISO 1087-1, Terminology work — Vocabulary — Part 1: Theory and application
[7] ISO 10241-1, Terminological entries in standards — Part 1: General requirements and examples of
presentation
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ISO 16443:2014(E/F)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions relatifs aux dispositifs médicaux utilisés en implantologie buccale .1
3.1 Implant dentaire . 1
3.2 Système d’implant dentaire . 2
3.3 Matériel ancillaire utilisé en implantologie buccale . 6
4 Termes et définitions relatifs aux concepts cliniques et chirurgicaux utilisés en
implantologie buccale . 8
Bibliographie .12
© ISO 2014 – All rights reserved/Tous droits réservés iii
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ISO 16443:2014(E/F)
Avant-propos
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