SIST EN ISO 7405:2009
(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)
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.
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
SIST EN ISO 7405:2009
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
SIST EN ISO 7405:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7405:2009
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SIST EN ISO 7405:2009
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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 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.
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SIST EN ISO 7405:2009
EN ISO 7405:2008 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 7405:2009
EN ISO 7405:2008 (E)
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.
3
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SIST EN ISO 7405:2009
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SIST EN ISO 7405:2009
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
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SIST EN ISO 7405:2009
ISO 7405:2008(E)
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ii © ISO 2008 – All rights reserved
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SIST EN ISO 7405:2009
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
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SIST EN ISO 7405:2009
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.
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SIST EN ISO 7405:2009
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.
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SIST EN ISO 7405:2009
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SIST EN ISO 7405:2009
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 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.
ISO 1942, Dentistry — Vocabulary
ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and
reproductive toxicity
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
1)
ISO 10993-10 , Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-12:2007, Biological evaluation of medical devices — Part 12: Sample preparation and reference
materials
ISO 14971, Medical devices — Application of risk management to medical devices
1) To be published.
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SIST EN ISO 7405:2009
ISO 7405:2008(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 10993-1, ISO 10993-12
and the following apply.
3.1
medical device
any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination,
together with any accessories, including the software necessary for its proper application intended by the
manufacturer to be used for medical purposes for human beings for the purpose of:
⎯ diagnosis, prevention, monitoring, treatment or alleviation of disease;
⎯ diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
⎯ investigation, replacement or modification of the anatomy or of a physiological process;
⎯ control of conception;
and which does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
3.2
dental material
material and/or substance or combination of materials and/or substances specially formulated and prepared
for use in the practice of dentistry and/or associated procedures
3.3
final product
medical device in its “as-used” state
NOTE Many dental materials are used in a freshly mixed state, and evaluation of the materials in both freshly mixed
and set conditions should be considered.
3.4
positive control
positive control material
any well characterized material and/or substance that, when evaluated by a specific test method,
demonstrates the suitability of the test system to yield a reproducible, appropriately positive or reactive
response in the test system
3.5
negative control
negative control material
any well characterized material and/or substance that, when evaluated by a specific test method,
demonstrates the suitability of the test system to yield a reproducible, appropriately negative, non-reactive or
minimal response in the test system
NOTE In practice, negative controls include blanks, vehicles/solvents and reference materials.
3.6
reference material
material with one or more property values that are sufficiently reproducible and well established to enable use
of the material or substance for the calibration of an apparatus, the assessment of a measurement method or
for the assignment of values to materials
NOTE For the purpose of this document, a reference material is any well characterized material and/or substance
that, when tested by the procedure described, demonstrates the suitability of the procedure to yield a reproducible,
predictable response. The response may be negative or positive.
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SIST EN ISO 7405:2009
ISO 7405:2008(E)
4 Categorization of medical devices
4.1 Categorization by nature of contact
4.1.1 General
For the purposes of this document, the classification of medical devices used in dentistry is derived from
ISO 10993-1. If a device or material can be placed in more than one category, the more rigorous testing
requirements shall apply. With multiple exposures the decision into which category a device is placed shall
take into account the potential cumulative effect, bearing in mind the period of time over which these
exposures occur.
NOTE In this context the term dentistry includes the oromaxillofacial environment.
4.1.2 Non-contact devices
These devices do not contact the patient's body directly or indirectly, and are not included in ISO 10993-1.
4.1.3 Surface-contacting devices
These devices include those that contact the surface of intact or breached or otherwise compromised skin, the
surface of intact or breached or otherwise compromised oral mucosa, and those that contact the external
surfaces of dental hard tissue, including enamel, dentine and cementum.
NOTE In some circumstances, dentine and cementum are considered as surfaces, e.g. after gingival recession.
4.1.4 External communicating devices
These devices include dental devices that penetrate and are in contact with oral mucosa, dental hard tissues,
dental pulp tissue or bone, or any combination of these, and are exposed to the oral environment.
NOTE This group also includes any kind of lining or base material to be used under a restoration.
4.1.5 Implant devices used in dentistry
These devices include dental implants and other dental devices that are partially or fully embedded in one or
more of the following:
a) soft tissue, e.g. subperiosteal implants and subdermal implants;
b) bone, e.g. endosteal implants and bone substitutes;
c) pulpodentinal system of the tooth, e.g. endodontic materials;
d) any combination of these, e.g. transosteal implants.
4.2 Categorization by duration of contact
4.2.1 General
For the purposes of this document, medical devices used in dentistry are classified by duration of contact as
described in ISO 10993-1 and listed in 4.2.2 to 4.2.4.
4.2.2 Limited exposure devices
Devices whose single or multiple use or contact is likely to be up to 24 h.
4.2.3 Prolonged exposure devices
Devices whose single, multiple or long-term use or contact is likely to exceed 24 h but not 30 d.
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ISO 7405:2008(E)
4.2.4 Permanent contact devices
Devices whose single, multiple or long-term use or contact exceeds 30 d.
NOTE 1 The definition of the term “permanent” is meant to be applied solely for the use of this document. It is
consistent with the definition given in ISO 10993-1.
NOTE 2 With multiple exposures to the device, the decision into which category a device is placed should take into
account the potential cumulative effect, bearing in mind the period of time over which these exposures occur.
5 Biological evaluation process
5.1 General
Each medical device used in dentistry shall be subjected to a structured biological evaluation programme
within a risk management process (see ISO 10993-1). Guidance on the implementation of this programme is
provided in ISO 14971 and ISO 10993-1. The biological evaluation programme shall include the review of data
sets concerning the biological properties of each medical device used in dentistry. When this part of the
biological evaluation programme indicates that one or more data sets are incomplete and that further testing is
necessary, the tests should be selected from the methods described in the ISO 10993 series of standards or
in this International Standard, or in both. If tests that are not included in these International Standards are
selected, a statement shall be made that indicates that the tests described in these International Standards
have been considered and shall include a justification for the selection of other tests.
For combination products the final product should be evaluated according to this document in conjunction with
any applicable standards.
NOTE 1 In this context, combination products are dental devices of any kind that incorporate, or are intended to
incorporate, as an integral part, a substance that:
a) if used separately, would be a medicine or a biological product;
b) is liable to affect the patient’s body by an ancillary action.
An example would be a bone filling/augmentation device containing a growth factor (i.e. a biological product).
NOTE 2 For combination products, where the device and pharmacological components are packaged separately, it
may be informative to test the device components alone.
5.2 Selection of tests and overall assessment
The selection of tests and the overall assessment of the results shall be carried out by an expert who has the
appropriate chemical, physical and biological data concerning the device and who is aware of the intended
conditions of use.
5.3 Selection of test methods
The selection of test methods shall be based upon consideration of:
a) the intended use of the medical device;
b) the tissue(s) which the medical device may contact;
c) the duration of the contact.
If a test selected is not included in the International Standards, a justification for the choice of the methods
shall be included in the test report for each device. If more than one test method in the same category is
recommended by the standards, the selection of one test over the others should be justified.
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SIST EN ISO 7405:2009
ISO 7405:2008(E)
5.4 Types of test
According to the categorization of the device, tests shall be considered for use as summarised in Table A.1.
This table indicates which types of test method shall be considered, but not that they are necessarily required
to be carried out. A decision not to carry out a type of test identified in Table A.1 shall be justified in the test
report on each device. The types of test listed are regarded as a framework for the evaluation of the
biocompatibility of medical devices used in dentistry. For most types of test, particular methods are identified,
although for some devices it is recognized that alternative methods not included in the International Standards
listed may be more appropriate.
For convenience, the types of test have been listed in three groups.
a) Group I
This group comprises in vitro tests of cytotoxicity. General guidance for in vitro cytotoxicity tests is presented
in ISO 10993-5 and shall be followed. Detailed test protocols for the agar or agarose diffusion and filter
diffusion methods, appropriate to dental materials, are included in this International Standard. The in vitro
cytotoxicity methods include:
1) agar diffusion test (see 6.2);
2) filter diffusion test (see 6.3);
3) direct contact or extract tests in accordance with ISO 10993-5;
4) dentine barrier cytotoxicity test (see Annex B);
5) tooth slice model.
NOTE 1 The order of listing does not indicate any preference for one method over another.
NOTE 2 This list does not indicate that all cytotoxicity tests mentioned have to be performed for each medical device
under consideration.
NOTE 3 The use of the dentine barrier cytotoxicity test is encouraged and a description of the test is presented in
Annex B. Another approach is the tooth slice model. References to this test are presented in the Bibliography.
b) Group II
This group comprises tests in accordance with the 10993 series of standards and particular tests, where
appropriate, are identified:
1) acute systemic toxicity — oral application — in accordance with ISO 10993-11;
2) acute systemic toxicity — application by inhalation — in accordance with ISO 10993-11;
3) subacute and subchronic systemic toxicity — oral application — in accordance with ISO 10993-11;
4) skin irritation and intracutaneous reactivity in accordance with ISO 10993-10;
5) delayed-type hypersensitivity in accordance with ISO 10993-10;
6) genotoxicity in accordance with ISO 10993-3;
7) local effects after implantation in accordance with ISO 10993-6.
NOTE 1 In order to allow use of the latest edition of the referenced document only, an undated cross-reference is
possible. An indication of the appropriate clause and subclause is only possible for dated references. Therefore, the user
of this International Standard is requested to check the referenced documents for the appropriate clause numbers.
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ISO 7405:2008(E)
NOTE 2 Information regarding acute toxicity testing is presented in Annex C.
NOTE 3 In the evaluation of materials following local implantation involving mineralized tissues in accordance with
ISO 10993-6, examination of undemineralized sections, in addition to routine demineralized sections, is recommended.
c) Group III
This group comprises tests, specific for medical devices used in dentistry, not referred to in the 10993 series
of standards:
1) pulp and dentine usage test (see 6.4);
2) pulp capping test (see 6.5);
3) endodontic usage test (see 6.6).
NOTE Dental implant system usage test in accordance with ISO/TS 22911 can also be considered, if applicable.
5.5 Re-evaluation of biocompatibility
In accordance with ISO 10993-1, a device shall be considered for re-evaluation of its biocompatibility as
described in 5.4 when revisions or modifications to the formula, quality and/or performance specifications are
made.
6 Test procedures specific to dental materials
6.1 Recommendations for sample preparation
6.1.1 General
These recommendations have been designed for in vitro testing, but can also be used for other purposes, if
suitable.
6.1.2 General recommendations for sample preparation
For the preparation of test samples, consult the respective product standards and/or the manufacturer’s
instructions, and follow those descriptions as closely as possible. Justify any deviation from the
manufacturer's instructions. A detailed description of the sample preparation shall be included in the test
report. Take the following (e.g. environmental) factors into account, considering the final use of the device:
a) temperature;
b) humidity;
c) light exposure: samples of photosensitive materials should be produced under the condition that
ambient light does not activate them;
d) material of sample mould: ensure that the material of the sample mould and eventual lubricant used do
not interfere w
...
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