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CEN

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

Status
Published
Publication Date
27-Nov-2018
Withdrawal Date
30-May-2019
ICS
11.060.10 - Dental materials
11.100 - Laboratory medicine
11.100.99 - Other standards related to laboratory medicine
Technical Committee
CEN/TC 55 - Dentistry
Drafting Committee
CEN/TC 55/WG 4 - Preclinical biological evaluation and testing
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
28-Nov-2018
Completion Date
28-Nov-2018
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Ref Project
SIST EN ISO 7405:2019 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)

Relations

Replaces
EN ISO 7405:2008/A1:2013 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material (ISO 7405:2008/Amd 1:2013)
Effective Date
08-Jun-2016
Replaces
EN ISO 7405:2008 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008)
Effective Date
08-Jun-2016

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7405:2019
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
SIST EN ISO 7405:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 7405:2019

---------------------- Page: 2 ----------------------
SIST EN ISO 7405:2019


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.

---------------------- Page: 3 ----------------------
SIST EN ISO 7405:2019
EN ISO 7405:2018 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 7405:2019
EN ISO 7405:2018 (E)
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, Cor
...

SLOVENSKI STANDARD
SIST EN ISO 7405:2019
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
SIST EN ISO 7405:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 7405:2019

---------------------- Page: 2 ----------------------

SIST EN ISO 7405:2019


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.

---------------------- Page: 3 ----------------------

SIST EN ISO 7405:2019
EN ISO 7405:2018 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 7405:2019
EN ISO 7405:2018 (E)
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.


3

---------------------- Page: 5 ----------------------

SIST EN ISO 7405:2019

---------------------- Page: 6 ----------------
...

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