EN ISO 22803:2005
(Main)Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
ISO 22803:2004 gives the requirements for a technical file on the evaluation of the chemical, physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whether resorbable, partially resorbable or non-resorbable, which are used
a) for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality,
b) in contact with teeth and/or dental implants,
c) for prevention of epithelial migration in periodontal surgery,
d) for the augmentation of bone prior to the planned insertion of dental implants,
e) and/or for augmentation of bone for stabilization of dental prostheses.
This International Standard is not applicable to materials whose primary intended use is to deliver a medicinal product, autografts and allografts, or materials intended to act through pharmacological, immunological or metabolic means.
Zahnheilkunde - Membranmaterialien für die gesteuerte Geweberegeneration bei oralen und maxillofazialen Eingriffen - Inhalt der Technischen Dokumentation (ISO 22803:2004)
Art dentaire - Membranes pour régénération de tissus en chirurgie buccale et maxillo-faciale - Contenu du dossier technique (ISO 22803:2004)
L'ISO 22803:2004 spécifie les exigences pour un dossier technique sur l'évaluation des aspects chimique, physique, mécanique, biologique et clinique des membranes, et leur comportement, qu'elles soient résorbables, partiellement résorbables ou non résorbables, utilisées
a) pour corriger un défaut morphologique ou une malformation par régénération de tissus en chirurgie buccale et maxillo-faciale;
b) au contact des dents et/ou des implants dentaires;
c) pour prévenir la migration épithéliale en chirurgie parodontale;
d) dans le but d'une augmentation osseuse avant la mise en place programmée des implants dentaires;
e) et/ou dans le but d'une augmentation osseuse pour la stabilisation des prothèses dentaires.
L'ISO 22803:2004 n'est pas applicable aux matériaux dont l'objectif principal est de libérer un médicament, aux autogreffes et allogreffes, ou à des matériaux destinés à agir par des moyens pharmacologiques, immunologiques ou métaboliques.
Zobozdravstvo – Membranski materiali za vodeno obnavljanje tkiva v ustni in maksilofacialni kirurgiji – Vsebina tehnične mape (ISO 22803:2004)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2006
=RER]GUDYVWYR±0HPEUDQVNLPDWHULDOL]DYRGHQRREQDYOMDQMHWNLYDYXVWQLLQ
PDNVLORIDFLDOQLNLUXUJLML±9VHELQDWHKQLþQHPDSH ,62
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial
surgery - Contents of a technical file (ISO 22803:2004)
Zahnheilkunde - Membranmaterialien für die gesteuerte Geweberegeneration bei oralen
und maxillofazialen Eingriffen - Inhalt der Technischen Dokumentation (ISO 22803:2004)
Art dentaire - Membranes pour régénération de tissus en chirurgie buccale et maxillo-
faciale - Contenu du dossier technique (ISO 22803:2004)
Ta slovenski standard je istoveten z: EN ISO 22803:2005
ICS:
11.060.15 Zobni implantati Dental implants
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 22803
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2005
ICS 11.060.15
English Version
Dentistry - Membrane materials for guided tissue regeneration in
oral and maxillofacial surgery - Contents of a technical file (ISO
22803:2004)
Art dentaire - Membranes pour régénération de tissus en Zahnheilkunde - Membranmaterialien für die gesteuerte
chirurgie buccale et maxillo-faciale - Contenu du dossier Geweberegeneration bei oralen und maxillofazialen
technique (ISO 22803:2004) Eingriffen - Inhalt der Technischen Dokumentation (ISO
22803:2004)
This European Standard was approved by CEN on 7 October 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22803:2005: E
worldwide for CEN national Members.
Foreword
The text of ISO 22803:2004 has been prepared by Technical Committee ISO/TC 106 "Dentistry”
of the International Organization for Standardization (ISO) and has been taken over as EN ISO
22803:2005 by 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 May 2006, and conflicting national standards
shall be withdrawn at the latest by May 2006.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 22803:2004 has been approved by CEN as EN ISO 22803:2005 without any
modifications.
INTERNATIONAL ISO
STANDARD 22803
First edition
2004-09-01
Dentistry — Membrane materials for
guided tissue regeneration in oral and
maxillofacial surgery — Contents of a
technical file
Art dentaire — Membranes pour régénération de tissus en chirurgie
buccale et maxillo-faciale — Contenu du dossier technique
Reference number
ISO 22803:2004(E)
©
ISO 2004
ISO 22803:2004(E)
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ii ISO 2004 – All rights reserved
ISO 22803:2004(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 22803 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 8, Dental implants.
©
ISO 2004 – All rights reserved iii
ISO 22803:2004(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.
Membrane materials for periodontal tissue reconstruction in oral and maxillofacial surgery are not covered by
the procedures for evaluating and testing dental restorative materials and dental implants, thus it is necessary
to develop a new International 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 membrane materials used in oral and maxillofacial surgery.
©
iv ISO 2004 – All rights reserved
INTERNATIONAL STANDARD ISO 22803:2004(E)
Dentistry — Membrane materials for guided tissue regeneration
in oral and maxillofacial surgery — Contents of a technical file
1Scope
This International Standard gives the requirements for a technical file on the evaluation of the chemical,
physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whether
resorbable, partially resorbable or non-resorbable, which are used
— for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or
abnormality,
— in contact with teeth and/or dental implants,
— for prevention of epithelial migration in periodontal surgery,
— for the augmentation of bone prior to the planned insertion of dental implants,
— and/or for augmentation of bone for stabilization of dental prostheses.
This International Standard is not applicable to materials whose primary intended use is to deliver a medicinal
product, autografts and allografts, or materials intended to act through pharmacological, immunological or
metabolic means.
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
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 11134, Sterilization of health care products — Requirements for validation and routine control — Industrial
moist heat sterilization
ISO 11135, Sterilization of health care products — Ethylene oxide — Requirements for development, validation
and routine control of a sterilization process for medical devices
ISO 11137, Sterilization of health care products — Requirements for validation and routine control — Radiation
sterilization
ISO 11607, Packaging for terminally sterilized medical devices
ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
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
1) Revision of ISO 1942-1:1989, ISO 1942-2:1989, ISO 1942-3:1989, ISO 1942-4:1989 and ISO 1942-5:1989.
©
ISO 2004 – All rights reserved 1
ISO 22803:2004(E)
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
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
periodontal tissue
all tissues constituting the dental periodontium, i.e. alveolar bone, gingival tissue, periodontal ligament and
cementum
3.2
biocompatibility
〈material action〉 capacity of a material to fulfill its function with an appropriate response for a specific application
in the recipient
3.3
biocompatibility
〈material reaction〉 quality of being accepted in a specific living environment without adverse or unwanted side
effects
[ISO 1942-1:1989/Amd.5:1993, definition 1.200]
3.4
biomaterial
〈general purpose〉 material intended to interface with the biological system to evaluate, treat, augment or
replace tissue, organ or function of the organism
3.5
biomaterial
〈tailored preparation〉 material specially prepared and/or presented to exhibit bioacceptability, biocompatibility or
positive biocompatiblity
[ISO 1942-1:1989/Amd.5:1993, definition 1.204]
NOTE The implantable materials referred to in this International Standard are all biomaterials.
3.6
membrane material
medical device specifically prepared as a material which, when placed into tissue, carries out a barrier function
NOTE The sheet may be occlusive or selectively permeable to cells, macromolecules and/or fluid.
3.7
barrier
structure which, when placed into tissue, prevents the intermixing of the cell population on each side of the
structure and/or prevents the prolapse of tissue
3.8
packing
surgical placement of a biomaterial to fill an intrabony cavity or defect
©
2 ISO 2004 – All rights reserved
ISO 22803:2004(E)
3.9
augmentation
surgical placement of autogenous bone and/or of a biomaterial, resorbable or non-resorbable, to increase the
volume of a bone or bridging of a defect
3.10
resorbable
ability of a membrane material to undergo progressive elimination by cellular activity and/or dissolution in a
biological environment
3.11
tissue regeneration
reproduction or reconstruction of a lost or injured tissue by induction, conduction or healing process
3.12
guided tissue regeneration
GTR
formation of tissue among which the orientation, the function, the volume and the place are pre-modelled by an
exogenous mean
3.13
guided bone regeneration
GBR
bone formation specifically obtained by GTR principles
4 General description
Membrane materials are widely used in periodontology and oral and maxillofacial surgery, and have
characteristics which are unique to these applications, for example:
a) placement in contact with teeth and their supporting tissues;
b) prevention of oral mucosal epithelial migration into surgically treated defects;
c) predictable loss of structural integrity and mechanical properties over time in oral sites into which dental
implants are to be subsequently placed;
d) known behaviour of the material should it become inadvertently exposed to the oral or paranasal cavities
subsequent to placement;
e) augmentation of the volume or dimension of bone for enhanced stabilization of dentures or for placement of
dental implants.
The development of membrane 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 n
...
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