EN ISO 7405:2018
(Main)Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
This document 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 document 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 7405:2018)
Médecine bucco-dentaire - Évaluation de la biocompatibilité des dispositifs médicaux utilisés en médecine bucco-dentaire (ISO 7405:2018)
Le présent document spécifie des méthodes d'essai pour l'évaluation des effets biologiques des dispositifs médicaux utilisés en médecine bucco-dentaire. Il inclut des essais de produits pharmacologiques qui font partie intégrante du dispositif soumis à essai.
Le présent document 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 7405:2018, popravljena verzija 2018-12)
Ta dokument določa preskusne metode za ovrednotenje bioloških učinkov medicinskih pripomočkov v zobozdravstvu. Vključuje preskušanje farmakoloških agentov, ki so ključen del pripomočka, ki se preskuša.
Ta dokument 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-januar-2019
Nadomešča:
SIST EN ISO 7405:2009
SIST EN ISO 7405:2009/A1:2013
Zobozdravstvo - Ovrednotenje biokompatibilnosti medicinskih pripomočkov v
zobozdravstvu (ISO 7405:2018, popravljena verzija 2018-12)
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO
7405:2018, Corrected version 2018-12)
Zahnheilkunde - Beurteilung der Biokompatibilität von in der Zahnheilkunde verwendeten
Medizinprodukten (ISO 7405:2018)
Médecine bucco-dentaire - Évaluation de la biocompatibilité des dispositifs médicaux
utilisés en médecine bucco-dentaire (ISO 7405:2018)
Ta slovenski standard je istoveten z: EN ISO 7405:2018
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 7405
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2018
EUROPÄISCHE NORM
ICS 11.060.10; 11.100.99 Supersedes EN ISO 7405:2008
English Version
Dentistry - Evaluation of biocompatibility of medical
devices used in dentistry (ISO 7405:2018, Corrected
version 2018-12)
Médecine bucco-dentaire - Évaluation de la Zahnheilkunde - Beurteilung der Biokompatibilität von
biocompatibilité des dispositifs médicaux utilisés en in der Zahnheilkunde verwendeten Medizinprodukten
médecine bucco-dentaire (ISO 7405:2018) (ISO 7405:2018)
This European Standard was approved by CEN on 17 August 2018.
This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 19 December 2018.
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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NOR M UN G
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7405:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 7405:2018) 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 May 2019, and conflicting national standards shall be
withdrawn at the latest by May 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7405:2008.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 7405:2018, Corrected version 2018-12 has been approved by CEN as EN ISO 7405:2018
without any modification.
INTERNATIONAL ISO
STANDARD 7405
Third edition
2018-10
Corrected version
2018-12
Dentistry — Evaluation of
biocompatibility of medical devices
used in dentistry
Médecine bucco-dentaire — Évaluation de la biocompatibilité des
dispositifs médicaux utilisés en médecine bucco-dentaire
Reference number
ISO 7405:2018(E)
©
ISO 2018
ISO 7405:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
ISO 7405:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Categorization of medical devices . 2
4.1 Categorization by nature of contact . 2
4.1.1 General. 2
4.1.2 Non-contact devices . 3
4.1.3 Surface-contacting devices . 3
4.1.4 External communicating devices . 3
4.1.5 Implant devices used in dentistry . 3
4.2 Categorization by duration of contact . 3
4.2.1 General. 3
4.2.2 Limited exposure devices . 3
4.2.3 Prolonged exposure devices . 3
4.2.4 Permanent contact devices . 4
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
5.4.1 General. 5
5.4.2 Physical and chemical characterization . 5
5.4.3 Group I . 5
5.4.4 Group II . 5
5.4.5 Group III . 6
5.5 Re-evaluation of biocompatibility . 6
6 Test procedures specific to dental materials . 6
6.1 Recommendations for sample preparation . 6
6.1.1 General. 6
6.1.2 General recommendations for sample preparation . 6
6.1.3 Specific recommendations for light curing materials . 7
6.1.4 Specific recommendations for chemically setting materials . 8
6.1.5 Positive control material . 8
6.2 Agar diffusion test . 8
6.2.1 Objective . . 8
6.2.2 Cell line . 8
6.2.3 Culture medium, reagents and equipment . 8
6.2.4 Sample preparation . 9
6.2.5 Controls . 9
6.2.6 Test procedure . 9
6.2.7 Parameters of assessment . 9
6.2.8 Assessment of results .10
6.2.9 Test report .11
6.3 Filter diffusion test .1
...
SLOVENSKI STANDARD
01-januar-2019
1DGRPHãþD
SIST EN ISO 7405:2009
SIST EN ISO 7405:2009/A1:2013
=RER]GUDYVWYR2YUHGQRWHQMHELRNRPSDWLELOQRVWLPHGLFLQVNLKSULSRPRþNRYY
]RER]GUDYVWYX ,62
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO
7405:2018)
Zahnheilkunde - Beurteilung der Biokompatibilität von in der Zahnheilkunde verwendeten
Medizinprodukten (ISO 7405:2018)
Médecine bucco-dentaire - Évaluation de la biocompatibilité des dispositifs médicaux
utilisés en médecine bucco-dentaire (ISO 7405:2018)
Ta slovenski standard je istoveten z: EN ISO 7405:2018
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.
EN ISO 7405
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2018
EUROPÄISCHE NORM
ICS 11.060.10; 11.100.99 Supersedes EN ISO 7405:2008
English Version
Dentistry - Evaluation of biocompatibility of medical
devices used in dentistry (ISO 7405:2018)
Médecine bucco-dentaire - Évaluation de la Zahnheilkunde - Beurteilung der Biokompatibilität von
biocompatibilité des dispositifs médicaux utilisés en in der Zahnheilkunde verwendeten Medizinprodukten
médecine bucco-dentaire (ISO 7405:2018) (ISO 7405:2018)
This European Standard was approved by CEN on 17 August 2018.
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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7405:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 7405:2018) 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 May 2019, and conflicting national standards shall be
withdrawn at the latest by May 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7405:2008.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 7405:2018 has been approved by CEN as EN ISO 7405:2018 without any modification.
INTERNATIONAL ISO
STANDARD 7405
Third edition
2018-10
Corrected version
2018-12
Dentistry — Evaluation of
biocompatibility of medical devices
used in dentistry
Médecine bucco-dentaire — Évaluation de la biocompatibilité des
dispositifs médicaux utilisés en médecine bucco-dentaire
Reference number
ISO 7405:2018(E)
©
ISO 2018
ISO 7405:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
ISO 7405:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Categorization of medical devices . 2
4.1 Categorization by nature of contact . 2
4.1.1 General. 2
4.1.2 Non-contact devices . 3
4.1.3 Surface-contacting devices . 3
4.1.4 External communicating devices . 3
4.1.5 Implant devices used in dentistry . 3
4.2 Categorization by duration of contact . 3
4.2.1 General. 3
4.2.2 Limited exposure devices . 3
4.2.3 Prolonged exposure devices . 3
4.2.4 Permanent contact devices . 4
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
5.4.1 General. 5
5.4.2 Physical and chemical characterization . 5
5.4.3 Group I . 5
5.4.4 Group II . 5
5.4.5 Group III . 6
5.5 Re-evaluation of biocompatibility . 6
6 Test procedures specific to dental materials . 6
6.1 Recommendations for sample preparation . 6
6.1.1 General. 6
6.1.2 General recommendations for sample preparation . 6
6.1.3 Specific recommendations for light curing materials . 7
6.1.4 Specific recommendations for chemically setting materials . 8
6.1.5 Positive control material . 8
6.2 Agar diffusion test . 8
6.2.1 Objective . . 8
6.2.2 Cell line . 8
6.2.3 Culture medium, reagents and equipment . 8
6.2.4 Sample preparation . 9
6.2.5 Controls . 9
6.2.6 Test procedure . 9
6.2.7 Parameters of assessment . 9
6.2.8 Assessment of results .10
6.2.9 Test report .11
6.3 Filter diffusion test .11
6.3.1 Objective . .11
6.3.2 Cell line .
...
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