EN 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

• Status: Withdrawn
• Publication Date: 14-Dec-2008
• Withdrawal Date: 27-Nov-2018
• ICS: 11.060.10 - Dental materials
• ICS: 11.100 - Laboratory medicine
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55/WG 4 - Preclinical biological evaluation and testing
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• 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 7405:2009 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008)

Relations

• Replaces: EN ISO 7405:1997 - Dentistry - Preclinical evaluation of biocompatability of medical devices used in dentistry - Test methods for dental materials (ISO 7405:1997)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 7405:2018 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
• Effective Date: 08-Jun-2016
• Amended By: 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-2022

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

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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.

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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



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