ISO 22794:2007
(Main)Dentistry — Implantable materials for bone filling and augmentation in oral and maxillofacial surgery — Contents of a technical file
Dentistry — Implantable materials for bone filling and augmentation in oral and maxillofacial surgery — Contents of a technical file
ISO 22794:2007 applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (greater than 90 %) hydroxyapatite are not covered by this International Standard. Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials.
Art dentaire — Matériaux implantables de comblement et de reconstruction osseuse en chirurgie orale et maxillofaciale — Contenu d'un dossier technique
L'ISO 22794:2007 s'applique aux matériaux implantables, qu'ils soient résorbables ou non, utilisés comme dispositifs dentaires de comblement et de reconstruction osseuse en chirurgie buccale et maxillofaciale. Les produits constitués d'hydroxyapatite quasiment pure (> 90 %) ne relèvent pas de la présente Norme internationale. L'évaluation inclut les aspects physico-chimiques, mécaniques, biologiques et cliniques ainsi que le comportement de ces matériaux dentaires implantables.
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INTERNATIONAL ISO
STANDARD 22794
First edition
2007-07-15
Corrected version
2009-01-15
Dentistry — Implantable materials for
bone filling and augmentation in oral and
maxillofacial surgery — Contents of a
technical file
Art dentaire — Matériaux implantables de comblement et de
reconstruction osseuse en chirurgie orale et maxillofaciale — Contenu
d'un dossier technique
Reference number
ISO 22794:2007(E)
©
ISO 2007
---------------------- Page: 1 ----------------------
ISO 22794:2007(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 2007
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 2007 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 22794:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Implantable materials .3
5 Technical file .3
5.1 Contents .3
5.2 Chemical composition .3
5.3 Physical properties.4
5.4 Intended applications, precautions, warnings and instructions .4
5.5 Preclinical and clinical evaluation .5
5.6 Manufacture.6
5.7 Materials of animal origin .6
5.8 Sterilization.6
5.9 Packaging .7
5.10 Additional information supplied by the manufacturer.7
Bibliography .9
© ISO 2007 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 22794:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 22794 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 8, Dental
implants.
In this corrected version of ISO 22794:2007 changes have been made to the list of Normative references
(Clause 2) and to the Bibliography. Consequently cross-references in subclauses 5.2, 5.5.5, 5.7, 5.8 and 5.9.2
have been altered.
Further, new subclauses 5.5.3 and 5.5.4 have been designated with the former 5.5.3 becoming 5.5.5.
iv © ISO 2007 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 22794:2007(E)
Introduction
Different materials used for the preservation of masticatory function, such as dental restorative materials and
dental implants are subject to standards and regulations, either in existence or in preparation, designed to
evaluate the performance of these products.
Implantable materials for bone filling and augmentation in oral and maxillofacial surgery are not covered by
the procedures for evaluating and testing dental restorative materials and dental implants; it is necessary to
develop a new standard for these materials.
The aim of this International Standard is to define the content of a technical file that demonstrates safety and
effectiveness of bone filling and augmentation materials used in oral and maxillofacial surgery.
© ISO 2007 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 22794:2007(E)
Dentistry — Implantable materials for bone filling and
augmentation in oral and maxillofacial surgery — Contents of a
technical file
1 Scope
This International Standard applies to implantable materials, whether resorbable or non-resorbable, used as
dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially
pure (> 90 %) hydroxyapatite are not covered by this International Standard.
Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these
implantable dental materials.
Materials such as autografts, allografts and membranes, and products for which the primary intended use is to
deliver a medicinal product, are not covered by this International Standard.
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.
1)
ISO 1942 , Dentistry — Vocabulary
2)
ISO 10993-1 , Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management system
ISO 10993-17, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for
leachable substances
3)
ISO 11135-1 , Sterilization of health care products — Ethylene oxide — Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices
4)
ISO 11137-1 , Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
5)
ISO 11607-2 , Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
1) To be published. (Revises and replaces ISO 1942 parts 1 to 5:1989)
2) To be published. (Revision of ISO 10993-1:2003)
3) Cancels and replaces ISO 11135:1994 and ISO 11135:1994/Cor.1:1994.
4) Cancels and replaces ISO 11137:1995, ISO 11137:1995/Cor.1:1997 and ISO 11137:1995/Amd.1:2001.
5) Cancels and replaces ISO 11607:2003.
© ISO 2007 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO 22794:2007(E)
ISO 13408-1, Aseptic processing of health care products — Part 1: General requirements
6)
ISO 14155-1 , Clinical investigation of medical devices for human subjects — Part 1: General requirements
6)
ISO 14155-2 , Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation
plans
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
7)
ISO 17665-1 , Sterilization of health care products — Moist heat — Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical devices
EN 1041, Information supplied by the manufacturer of medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
biocompatibility
a) capability of a material to fulfil its function with an appropriate response for a specific application from the
receiving host;
b) quality of being accepted in a specific living environment without adverse or unwanted side effects
3.2
biomaterial
a) material intended to interface with the biological system to evaluate, treat, augment or replace tissue,
organ or function of the organism;
b) material specially prepared and/or presented to exhibit bioacceptability, biocompatibility or positive
biocompatiblity
NOTE The implantable materials referred to in this document are all biomaterials.
3.3
filling
surgical placement of a biomaterial, resorbable or non-resorbable, into an intrabony cavity during oral and
maxillofacial surgery
NOTE Intrabony cavity includes extraction socket.
3.4
augmentation
surgical placement of a biomaterial, resorbable or non-resorbable, to increase the volume of bone, usually on
the sinus floor or the alveolar ridges
6) Cancels and replaces ISO 14155:1996.
7) Cancels and replaces ISO 11134:1994 and ISO 13683:1997.
2 © ISO 2007 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 22794:2007(E)
3.5
resorption
progressive elimination by cellular activity and/or dissolution of a material in a biological environment
3.6
medicinal product
substance that produces its intended effect by pharmaceutical means
4 Implantable materials
The development of implantable materials shall be considered with regard to the properties required for the
intended purpose, taking into account the effects of manufacture, handling, sterilization and storage. Possible
reactions (intended or not) of implantable materials with human tissues and body fluids, other materials, other
implants, substances, gases, radiation and electromagnetic fields shall be considered.
Implantable materials for bone reconstruction in oral and maxillofacial surgery are used either for filling or
augmentation.
5 Technical file
5.1 Contents
The contents of a technical file shall include at least the following:
⎯ details of the chemical composition and physical properties of the implantable material;
⎯ its intended performance;
⎯ its preclinical and clinical evaluation;
⎯ details of its manufacture, sterilization and packaging;
⎯ all information necessary for the user (as detailed later).
New materials, for which the following characterization methods may not be adequate, shall be characterized
using techniques appropriate to the materials and the choice of technique shall be justified.
5.2 Chemical composition
As appropriate, the following shall apply.
The complete chemical composition, summing to 100 % by mass, including all additives, shall be described.
The crystalline and non-crystalline phases, phase purity, and the mass fractions of phases, using X-ray
diffraction (XRD), Fourier transform infrared spectroscopy (FTIR) and/or differential scanning calorimetry
(DSC), as appropriate, shall be described.
The composition description shall also include elemental analysis, identifying the cation to anion ratio (e.g.,
Ca/P, Ca/S) and/or the carbon/oxygen/nitrogen ratios (e.g., C/O/N), as appropriate, and all trace impurities
relevant to the appli
...
INTERNATIONAL ISO
STANDARD 22794
First edition
2007-07-15
Dentistry — Implantable materials for
bone filling and augmentation in oral and
maxillofacial surgery — Contents of a
technical file
Art dentaire — Matériaux implantables pour le remplissage et
l'augmentation osseuse en chirurgie orale et maxillofaciale — Contenu
d'un dossier technique
Reference number
ISO 22794:2007(E)
©
ISO 2007
---------------------- Page: 1 ----------------------
ISO 22794:2007(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 2007
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 2007 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 22794:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Implantable materials.2
5 Technical file.3
5.1 Contents .3
5.2 Chemical composition .3
5.3 Physical properties.3
5.4 Intended applications, precautions, warnings and instructions .4
5.5 Preclinical and clinical evaluation .4
5.6 Manufacture.6
5.7 Materials of animal origin .6
5.8 Sterilization.6
5.9 Packaging.7
5.10 Additional information supplied by the manufacturer.7
Bibliography .8
© ISO 2007 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 22794:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 22794 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 8, Dental
implants.
iv © ISO 2007 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 22794:2007(E)
Introduction
Different materials used for the preservation of masticatory function, such as dental restorative materials and
dental implants are subject to standards and regulations, either in existence or in preparation, designed to
evaluate the performance of these products.
Implantable materials for bone filling and augmentation in oral and maxillofacial surgery are not covered by
the procedures for evaluating and testing dental restorative materials and dental implants; it is necessary to
develop a new standard for these materials.
The aim of this International Standard is to define the content of a technical file that demonstrates safety and
effectiveness of bone filling and augmentation materials used in oral and maxillofacial surgery.
© ISO 2007 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 22794:2007(E)
Dentistry — Implantable materials for bone filling and
augmentation in oral and maxillofacial surgery — Contents of a
technical file
1 Scope
This International Standard applies to implantable materials, whether resorbable or non-resorbable, used as
dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially
pure (> 90 %) hydroxyapatite are not covered by this International Standard.
Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these
implantable dental materials.
Materials such as autografts, allografts and membranes, and products for which the primary intended use is to
deliver a medicinal product, are not covered by this International Standard.
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.
1)
ISO 1942:— , Dentistry — Vocabulary
2)
ISO 10993-1:— , Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management system
ISO 10993-17, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for
leachable substances
3)
ISO 11134 , Sterilization of health care products — Requirements for validation and routine control —
Industrial moist heat sterilization
ISO 11135:1994, Medical devices — Validation and routine control of ethylene oxide sterilization
ISO 11137:1995, Sterilization of health care products — Requirements for validation and routine control —
Radiation sterilization
ISO 11607:2003, Packaging for terminally sterilized medical devices
ISO 13408-1, Aseptic processing of health care products — Part 1: General requirements
1) To be published. (Revises and replaces ISO 1942 parts 1 to 5:1989)
2) To be published. (Revision of ISO 10993:2003)
3) International Standard withdrawn.
© ISO 2007 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO 22794:2007(E)
ISO 14155:1996, Clinical investigation of medical devices
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and information
to be supplied
EN 1041, Information supplied by the manufacturer with medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
biocompatibility
a) capability of a material to fulfil its function with an appropriate response for a specific application from the
receiving host;
b) quality of being accepted in a specific living environment without adverse or unwanted side effects
3.2
biomaterial
a) material intended to interface with the biological system to evaluate, treat, augment or replace tissue,
organ or function of the organism;
b) material specially prepared and/or presented to exhibit bioacceptability, biocompatibility or positive
biocompatiblity
NOTE The implantable materials referred to in this document are all biomaterials.
3.3
filling
surgical placement of a biomaterial, resorbable or non-resorbable, into an intrabony cavity during oral and
maxillofacial surgery
NOTE Intrabony cavity includes extraction socket.
3.4
augmentation
surgical placement of a biomaterial, resorbable or non-resorbable, to increase the volume of bone, usually on
the sinus floor or the alveolar ridges
3.5
resorption
progressive elimination by cellular activity and/or dissolution of a material in a biological environment
3.6
medicinal product
substance that produces its intended effect by pharmaceutical means
4 Implantable materials
The development of implantable materials shall be considered with regard to the properties required for the
intended purpose, taking into account the effects of manufacture, handling, sterilization and storage. Possible
2 © ISO 2007 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 22794:2007(E)
reactions (intended or not) of implantable materials with human tissues and body fluids, other materials, other
implants, substances, gases, radiation and electromagnetic fields shall be considered.
Implantable materials for bone reconstruction in oral and maxillofacial surgery are used either for filling or
augmentation.
5 Technical file
5.1 Contents
The contents of a technical file shall include at least the following:
⎯ details of the chemical composition and physical properties of the implantable material;
⎯ its intended performance;
⎯ its preclinical and clinical evaluation;
⎯ details of its manufacture, sterilization and packaging;
⎯ all information necessary for the user (as detailed later).
New materials, for which the following characterization methods may not be adequate, shall be characterized
using techniques appropriate to the materials and the choice of technique shall be justified.
5.2 Chemical composition
As appropriate, the following shall apply.
The complete chemical composition, summing to 100 % by mass, including all additives, shall be described.
The crystalline and non-crystalline phases, phase purity, and the mass fractions of phases, using X-ray
diffraction (XRD), Fourier transform infrared spectroscopy (FTIR) and/or differential scanning calorimetry
(DSC), as appropriate, shall be described.
The composition description shall also include elemental analysis, identifying the cation to anion ratio (e.g.,
Ca/P, Ca/S) and/or the carbon/oxygen/nitrogen ratios (e.g., C/O/N), as appropriate, and all trace impurities
relevant to the application.
Diffraction patterns, along with superimposed patterns of each phase as given for the relevant calcium salt
and available from the International Center for Diffraction Data/Joint Committee on Powder Diffraction
Standards (ICDD/JCPDS), shall be described.
NOTE Several standards that address the specifics of different materials are available and can be useful references
for other bone-filling materials. See references [15], [16], [17], [18], [19].
5.3 Physical proper
...
NORME ISO
INTERNATIONALE 22794
Première édition
2007-07-15
Art dentaire — Matériaux implantables
de comblement et de reconstruction
osseuse en chirurgie orale et
maxillofaciale — Contenu d'un dossier
technique
Dentistry — Implantable materials for bone filling and augmentation
in oral and maxillofacial surgery — Contents of a technical file
Numéro de référence
ISO 22794:2007(F)
©
ISO 2007
---------------------- Page: 1 ----------------------
ISO 22794:2007(F)
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© ISO 2007
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
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E-mail copyright@iso.org
Web www.iso.org
Version française parue en 2009
Publié en Suisse
ii © ISO 2007 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 22794:2007(F)
Sommaire
Avant-propos .iv
Introduction.v
1 Domaine d'application .1
2 Références normatives .1
3 Termes et définitions .2
4 Matériaux implantables.3
5 Dossier technique.3
5.1 Contenu .3
5.2 Composition chimique.3
5.3 Propriétés physiques .4
5.4 Applications prévues, précautions, avertissements et instructions .4
5.5 Évaluation préclinique et clinique .5
5.6 Fabrication .7
5.7 Matériaux d'origine animale .7
5.8 Stérilisation .7
5.9 Emballage.7
5.10 Informations complémentaires fournies par le fabricant.8
Bibliographie.9
© ISO 2007 – Tous droits réservés iii
---------------------- Page: 3 ----------------------
ISO 22794:2007(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 22794 a été élaborée par le comité technique ISO/TC 106, Art dentaire, sous-comité SC 8, Implants
dentaires.
iv © ISO 2007 – Tous droits réservés
---------------------- Page: 4 ----------------------
ISO 22794:2007(F)
Introduction
Différents produits utilisés pour la préservation de la fonction masticatoire, comme les produits dentaires de
restauration et les implants dentaires, font l'objet de normes et de réglementations, en vigueur ou en
préparation, conçues pour évaluer la performance de ces produits.
Les matériaux implantables de comblement et de reconstruction osseuse en chirurgie orale et maxillofaciale
ne relèvent pas des modes opératoires d'évaluation et d'essai des produits dentaires de restauration et des
implants dentaires; il est donc nécessaire d'élaborer une nouvelle norme pour ces produits.
La présente Norme internationale a pour objet de définir le contenu d'un fichier technique visant à démontrer
la sécurité et l'efficacité des produits de comblement et de reconstruction osseuse utilisés en chirurgie orale et
maxillofaciale.
© ISO 2007 – Tous droits réservés v
---------------------- Page: 5 ----------------------
NORME INTERNATIONALE ISO 22794:2007(F)
Art dentaire — Matériaux implantables de comblement et de
reconstruction osseuse en chirurgie orale et maxillofaciale —
Contenu d'un dossier technique
1 Domaine d'application
La présente Norme internationale s'applique aux matériaux implantables, qu'ils soient résorbables ou non,
utilisés comme dispositifs dentaires de comblement et de reconstruction osseuse en chirurgie orale et
maxillofaciale. Les produits constitués d'hydroxyapatite quasiment pure (> 90 %) ne relèvent pas de la
présente Norme internationale.
L'évaluation inclut les aspects physico-chimiques, mécaniques, biologiques et cliniques ainsi que le
comportement de ces matériaux dentaires implantables.
Les produits tels que les autogreffes, les allogreffes et les membranes, ou les produits conçus pour délivrer un
produit pharmaceutique, ne relèvent pas de la présente Norme internationale.
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).
1)
ISO 1942, Art dentaire — Vocabulaire
ISO 10993-1, Évaluation biologique des dispositifs médicaux — Partie 1: Évaluation et essais au sein d'un
2)
système de gestion du risque
ISO 10993-17, Évaluation biologique des dispositifs médicaux — Partie 17: Établissement des limites
admissibles des substances relargables
ISO 11135-1, Stérilisation des produits de santé — Oxyde d'éthylène — Partie 1: Exigences de
développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs
3)
médicaux
ISO 11137-1, Stérilisation des produits de santé — Irradiation — Partie 1: Exigences relatives à la mise au
4)
point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux
1) À publier. (Révision de l'ISO 1942-1:1989 à l'ISO 1942-5:1989)
2) À publier. (Révision de l'ISO 10993-1:2003)
3) Annule et remplace l'ISO 11135:1994 et l'ISO 11135:1994/Cor.1:1994.
4) Annule et remplace l'ISO 11137:1995, l'ISO 11137:1995/Cor.1:1997 et l'ISO 11137:1995/Amd.1:2001.
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ISO 22794:2007(F)
ISO 11607-1, Emballages des dispositifs médicaux stérilisés au stade terminal — Partie 1: Exigences
5)
relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage
ISO 11607-2, Emballages des dispositifs médicaux stérilisés au stade terminal — Partie 2: Exigences de
5)
validation pour les procédés de formage, scellage et assemblage
ISO 13408-1, Traitement aseptique des produits de santé — Partie 1: Exigences générales
ISO 14155-1, Investigation clinique des dispositifs médicaux pour sujets humains — Partie 1: Exigences
6)
générales
ISO 14155-2, Investigation clinique des dispositifs médicaux pour sujets humains — Partie 2: Plans
6)
d'investigation clinique
ISO 14937, Stérilisation des produits de santé — Exigences générales pour la caractérisation d'un agent
stérilisant et pour le développement, la validation et la vérification de routine d'un processus de stérilisation
pour dispositifs médicaux
ISO 14971, Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux
ISO 15223, Dispositifs médicaux — Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à
fournir relatifs aux dispositifs médicaux
ISO 17665-1, Stérilisation des produits de santé — Chaleur humide — Partie 1: Exigences pour le
7)
développement, la validation et le contrôle de routine d'un procédé de stérilisation des dispositifs médicaux
8)
EN 1041, Informations fournies par le fabricant avec les dispositifs médicaux
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
biocompatibilité
a) capacité d'un matériau à remplir sa fonction en induisant une réponse appropriée du receveur dans le
cadre d'une application spécifique
b) qualité de ce qui est accepté dans un environnement vivant spécifique, sans effet contraire ou non désiré
3.2
biomatériau
a) matériau destiné à interagir avec le système biologique pour évaluer, traiter, augmenter ou remplacer un
tissu, un organe ou une fonction de l'organisme
b) produit spécialement préparé et/ou présenté pour être bioacceptable, biocompatible ou à compatibilité
active
NOTE Les matériaux implantables mentionnés dans le présente Norme internationale sont tous des biomatériaux.
5) Annule et remplace l'ISO 11607:2003.
6) Annule et remplace l'ISO 14155:1996.
7) Annule et remplace l'ISO 11134:1994 ainsi que l'ISO 13683:1997.
8) À publier.
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3.3
comblement
mise en place d'un biomatériau, résorbable ou non, dans une cavité intra-osseuse par chirurgie orale et
maxillofaciale
NOTE La cavité intra-osseuse inclut l'alvéole dentaire après extraction.
3.4
reconstruction
mise en place chirurgicale d'un biomatériau, résorbable ou non, pour augmenter le volume de l'os,
généralement à la base du sinus ou au niveau des crêtes alvéolaires
3.5
résorption
élimination progressive, par activité cellulaire et/ou dissolution, d'un matériau dans un environnement
biologique
3.6
produit pharmaceutique
substance qui produit l'effet souhaité par des moyens pharmaceutiques
4 Matériaux implantables
La mise au point des matériaux implantables doit s'effectuer en vertu des propriétés requises pour l'usage
prévu, compte tenu des effets liés à la fabrication, à la manipulation, à la stérilisation et au stockage. Les
réactions possibles (souhaitées ou non) des matériaux implantables avec les tissus humains et les liquides
corporels, avec d'autres matériaux, d'autres implants, des substances, des gaz, des rayonnements ou des
champs électromagnétiques doivent être prises en compte.
Les matériaux implantables de reconstruction osseuse en chirurgie orale et maxillofaciale sont utilisés pour le
comblement ou pour la reconstruction.
5 Dossier technique
5.1 Contenu
Le dossier technique doit inclure au moins les points suivants:
⎯ des détails sur la composition chimique et les propriétés physiques du matériau implantable;
⎯ ses performances prévues;
⎯ son évaluation préclinique et clinique;
⎯ des précisions concernant sa fabrication, sa stérilisation et son emballage;
⎯ toutes les informations nécessaires à l'utilisateur (détaillées ci-après).
Les nouveaux matériaux, pour lesquels les méthodes de caractérisation suivantes peuvent ne pas convenir,
doivent être caractérisés selon des techniques adaptées, et le choix de la technique doit être justifié.
5.2 Composition chimique
Les dispositions suivantes doivent s'appliquer.
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⎯ Décrire la composition chimique complète, à hauteur de 100 % en masse, y compris tous les additifs.
⎯ Décrire les phases cristalline et non cristalline, la pureté et les fractions massiques de ces phases, après
analyse par diffraction de rayons X (XRD), par spectroscopie à infrarouge de Fourier (FTPIR) et/ou par
calorimétrie à balayage différentiel (DSC), selon le cas.
La description de la composition doit également inclure l'analyse des éléments, l'identification du rapport
cations/anions (par exemple Ca/P, Ca/S) et/ou des rapports carbone/oxygène/azote (par exemple C/O/N),
selon le cas, ainsi que toutes les impuretés sous forme de traces correspondant à l'application.
Décrire les diagrammes de diffraction avec les diagrammes superposés de chaque phase pour le sel de
calcium considéré, disponibles auprès du Centre international des données de diffraction/Comité mixte sur les
normes de diffraction des poudres (ICDD/JCPDS).
NOTE Il existe plusieurs normes concernant les spécificités des différents matériaux, et ces normes peuvent être des
références uti
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