SIST EN ISO 22794:2007

SLOVENSKI STANDARD
SIST EN ISO 22794:2007
01-september-2007
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Dentistry - Implantable materials for bone filling and augmentation in oral and
maxillofacial surgery - Contents of a technical file (ISO 22794:2007)
Zahnheilkunde - Implantierbare Materialien zur Auffüllung von Knochendefekten und zur
Augmentation bei oralen und maxillofazialen Eingriffen - Inhalt der Technischen
Dokumentation (ISO 22794:2007)
Art dentaire - Matériaux implantables pour le remplissage et l'augmentation osseuse
dans la chirurgie orale et maxillofaciale - Contenu d'un dossier technique (ISO
22794:2007)
Ta slovenski standard je istoveten z: EN ISO 22794:2007
ICS:
11.060.15 Zobni implantati Dental implants
SIST EN ISO 22794:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 22794
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2007
ICS 11.060.15

English Version
Dentistry - Implantable materials for bone filling and
augmentation in oral and maxillofacial surgery - Contents of a
technical file (ISO 22794:2007)
Art dentaire - Matériaux implantables pour le remplissage et Zahnheilkunde - Implantierbare Materialien zum Auffüllung
l'augmentation osseuse en chirurgie orale et maxillofaciale von Knochendefekten und zur Augmentation bei oralen und
- Contenu d'un dossier technique (ISO 22794:2007) maxillofazialen Eingriffen - Inhalt der Technischen
Dokumentation (ISO 22794:2007)
This European Standard was approved by CEN on 20 June 2007.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22794:2007: E
worldwide for CEN national Members.

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EN ISO 22794:2007 (E)





Foreword


This document (EN ISO 22794:2007) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 "Dentistry", the secretariat of
which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by January 2008, and conflicting national
standards shall be withdrawn at the latest by January 2008.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.


Endorsement notice

The text of ISO 22794:2007 has been approved by CEN as EN ISO 22794:2007 without any
modifications.

2

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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

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ISO 22794:2007(E)
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ii © ISO 2007 – All rights reserved

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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

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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

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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

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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

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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
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