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)

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 - ÄNDERUNG 1: Positivkontrolle (ISO 7405:2008/Amd 1:2013)

Art dentaire - Évaluation de la biocompatibilité des dispositifs médicaux utilisés en art dentaire - Amendement 1: Matériaux de contrôle positif (ISO 7405:2008/Amd 1:2013)

Zobozdravstvo - Ovrednotenje biokompatibilnosti medicinskih pripomočkov v zobozdravstvu - Dopolnilo A1: Pozitivna kontrola materiala (ISO 7405:2008/Amd 1:2013)

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• Status: Withdrawn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: 23-Jul-2013
• Withdrawal Date: 27-Nov-2018
• ICS: 11.060.10 - Dental materials
• ICS: 11.100.20 - Biological evaluation of medical devices
• ICS: 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: 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/A1:2013 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material (ISO 7405:2008/Amd 1:2013)

Relations

• 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
• Amends: EN ISO 7405:2008 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7405:2009/A1:2013
01-november-2013
=RER]GUDYVWYR2YUHGQRWHQMHELRNRPSDWLELOQRVWLPHGLFLQVNLKSULSRPRþNRYY
]RER]GUDYVWYX'RSROQLOR$3R]LWLYQDNRQWURODPDWHULDOD,62$PG

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry -
Amendment 1: Positive control material (ISO 7405:2008/Amd 1:2013)
Zahnheilkunde - Beurteilung der Biokompatibilität von in der Zahnheilkunde verwendeten
Medizinprodukten - ÄNDERUNG 1: Positivkontrolle (ISO 7405:2008/Amd 1:2013)
Art dentaire - Évaluation de la biocompatibilité des dispositifs médicaux utilisés en art
dentaire - Amendement 1: Matériaux de contrôle positif (ISO 7405:2008/Amd 1:2013)
Ta slovenski standard je istoveten z: EN ISO 7405:2008/A1:2013
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/A1:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7405:2009/A1:2013

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SIST EN ISO 7405:2009/A1:2013


EUROPEAN STANDARD
EN ISO 7405:2008/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2013
ICS 11.060.10; 11.100.99
English Version
Dentistry - Evaluation of biocompatibility of medical devices
used in dentistry - Amendment 1: Positive control material (ISO
7405:2008/Amd 1:2013)
Art dentaire - Évaluation de la biocompatibilité des Zahnheilkunde - Beurteilung der Biokompatibilität von in der
dispositifs médicaux utilisés en art dentaire - Amendement Zahnheilkunde verwendeten Medizinprodukten -
1: Matériaux de contrôle positif (ISO 7405:2008/Amd ÄNDERUNG 1: Positivkontrolle (ISO 7405:2008/Amd
1:2013) 1:2013)
This amendment A1 modifies the European Standard EN ISO 7405:2008; it was approved by CEN on 15 May 2013.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant 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 amendment 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7405:2008/A1:2013: E
worldwide for CEN national Members.

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SIST EN ISO 7405:2009/A1:2013
EN ISO 7405:2008/A1:2013 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 7405:2009/A1:2013
EN ISO 7405:2008/A1:2013 (E)
Foreword
This document (EN ISO 7405:2008/A1:2013) 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 Amendment to the European Standard EN ISO 7405:2008 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by January 2014, and
conflicting national standards shall be withdrawn at the latest by January 2014.
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.
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, Slovakia, Slo
...