EN ISO 7405:2008
(Main)Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008)
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008)
ISO 7405:2008 specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
Zahnheilkunde - Beurteilung der Biokompatibilität von in der Zahnheilkunde verwendeten Medizinprodukten (ISO 7405:2008)
Diese Internationale Norm legt Prüfverfahren zur Beurteilung der biologischen Wirkungen von in der Zahnheilkunde verwendeten Medizinprodukten fest. Enthalten sind auch Prüfungen von pharmakologischen Stoffen, die ein integraler Bestandteil des zu prüfenden Medizinproduktes sind.
Diese Internationale Norm gilt nicht für die Prüfung von Materialien und Produkten, die weder direkt noch indirekt mit dem Körper des Patienten in Kontakt kommen.
Art dentaire - Évaluation de la biocompatibilité des dispositifs médicaux utilisés en art dentaire (ISO 7405:2008)
L'ISO 7405:2008 spécifie des méthodes d'essai pour l'évaluation des effets biologiques des dispositifs médicaux utilisés en art dentaire. Elle inclut des essais de produits pharmacologiques qui font partie intégrante du dispositif en cours d'essai.
L'ISO 7405:2008 ne couvre pas les essais des matériaux et des dispositifs qui n'entrent pas en contact direct ou indirect avec le corps du patient.
Zobozdravstvo - Ovrednotenje biokompatibilnosti medicinskih pripomočkov v zobozdravstvu (ISO 7405:2008)
Ta mednarodni standard določa preskusne metode za ovrednotenje bioloških učinkov medicinskih pripomočkov v zobozdravstvu. Vključuje preskušanje farmakoloških agentov, ki so ključen del pripomočka, ki se preskuša. Ta mednarodni standard ne zajema preskušanja materialov in pripomočkov, ki ne prihajajo v neposreden ali posreden stik z bolnikovim telesom.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2009
1DGRPHãþD
SIST EN ISO 7405:2000
=RER]GUDYVWYR2YUHGQRWHQMHELRNRPSDWLELOQRVWLPHGLFLQVNLKSULSRPRþNRYY
]RER]GUDYVWYX ,62
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO
7405:2008)
Zahnheilkunde - Beurteilung der Biokompatibilität von in der Zahnheilkunde verwendeten
Medizinprodukten (ISO 7405:2008)
Art dentaire - Évaluation de la biocompatibilité des dispositifs médicaux utilisés en art
dentaire (ISO 7405:2008)
Ta slovenski standard je istoveten z: EN ISO 7405:2008
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 7405
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2008
ICS 11.060.10; 11.100 Supersedes EN ISO 7405:1997
English Version
Dentistry - Evaluation of biocompatibility of medical devices
used in dentistry (ISO 7405:2008)
Art dentaire - Évaluation de la biocompatibilité des Zahnheilkunde - Beurteilung der Biokompatibilität von in der
dispositifs médicaux utilisés en art dentaire (ISO Zahnheilkunde verwendeten Medizinprodukten (ISO
7405:2008) 7405:2008)
This European Standard was approved by CEN on 5 December 2008.
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.
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© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7405:2008: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 7405:2008) 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 June 2009, and conflicting national standards shall be withdrawn at
the latest by June 2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7405:1997.
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 the United Kingdom.
Endorsement notice
The text of ISO 7405:2008 has been approved by CEN as a EN ISO 7405:2008 without any modification.
INTERNATIONAL ISO
STANDARD 7405
Second edition
2008-12-15
Dentistry — Evaluation of
biocompatibility of medical devices used
in dentistry
Art dentaire — Évaluation de la biocompatibilité des dispositifs
médicaux utilisés en art dentaire
Reference number
ISO 7405:2008(E)
©
ISO 2008
ISO 7405:2008(E)
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ii © ISO 2008 – All rights reserved
ISO 7405:2008(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Categorization of medical devices .3
4.1 Categorization by nature of contact .3
4.2 Categorization by duration of contact.3
5 Biological evaluation process.4
5.1 General .4
5.2 Selection of tests and overall assessment.4
5.3 Selection of test methods.4
5.4 Types of test .5
5.5 Re-evaluation of biocompatibility.6
6 Test procedures specific to dental materials .6
6.1 Recommendations for sample preparation .6
6.2 Agar diffusion test.8
6.3 Filter diffusion test .10
6.4 Pulp and dentine usage test.13
6.5 Pulp capping test.17
6.6 Endodontic usage test.19
Annex A (informative) Types of test to be considered for evaluation of biocompatibility of medical
devices used in dentistry.23
Annex B (informative) Dentine barrier cytotoxicity test.25
Annex C (informative) Acute toxicity testing .32
Bibliography.33
ISO 7405:2008(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 7405 was prepared by Technical Committee ISO/TC 106, Dentistry.
This second edition cancels and replaces the first edition (ISO 7405:1997) which has been technically revised.
The following changes have been made:
a) addition of dentine barrier cytotoxicity test to Annex B;
b) improved description of test methods;
c) updated cross-references to ISO 10993 series.
iv © ISO 2008 – All rights reserved
ISO 7405:2008(E)
Introduction
This International Standard concerns the evaluation of the biocompatibility of medical devices used in
dentistry. It is to be used in conjunction with the ISO 10993 series of standards. This International Standard
contains special tests, for which ample experience exists in dentistry and which acknowledge the special
needs of dentistry.
Only test methods for which the members of the committee considered there was sufficient published data
have been included. In recommending test methods, the need to minimize the use of animals was given a
high priority. It is essential that the decision to undertake tests involving animals be reached only after a full
and careful review of the evidence indicating that a similar outcome cannot be achieved by other types of test.
In order to keep the number of animals required for tests to an absolute minimum, consistent with achieving
the objective indicated, it can be appropriate to conduct more than one type of test on the same animal at the
same time, e.g. pulp and dentin usage test and pulp capping test. However, in accordance with ISO 10993-2
these tests are performed both in an efficient and humane way. On all occasions when animal testing is
undertaken, such tests are conducted empathetically and according to standardized procedures as described
for each test.
This International Standard does not explicitly describe test methods for occupationally related risks.
Annexes B and C are included to encourage the development of in vitro and ex vivo test methods which will
further reduce the use of animals in the evaluation of the biocompatibility of medical devices used in dentistry.
INTERNATIONAL STANDARD ISO 7405:2008(E)
Dentistry — Evaluation of biocompatibility of medical devices
used in dentistry
1 Scope
This International Standard specifies test methods for the evaluation of biological effects of medical devices
used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under
test.
This International Standard does not cover testing of materials and devices that do not come into direct or
indirect contact with the patient's body.
2 Normative references
The following referenced documents are indispensable for the ap
...
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