EN ISO 7405:2008/A1:2013
(Amendment)Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material (ISO 7405:2008/Amd 1:2013)
General Information
- Abstract
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.
- Status
- Withdrawn
- Publication Date
- 23-Jul-2013
- Withdrawal Date
- 22-Sep-2026
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55/WG 4 - Preclinical biological evaluation and testing
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 28-Nov-2018
- Completion Date
- 23-Sep-2026
- Directive
- Not Harmonized93/42/EEC - Medical devices
Relations
- Effective Date
- 08-Jun-2016
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 12-Feb-2026
- Effective Date
- 08-Jun-2022
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Frequently Asked Questions
EN ISO 7405:2008/A1:2013 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material (ISO 7405:2008/Amd 1:2013)". This standard covers: 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.
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.
EN ISO 7405:2008/A1:2013 is classified under the following ICS (International Classification for Standards) categories: 11.060.10 - Dental materials; 11.100.20 - Biological evaluation of medical devices; 11.100.99 - Other standards related to laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 7405:2008/A1:2013 has the following relationships with other standards: It is inter standard links to EN ISO 7405:2018, EN ISO 3691-1:2012, EN ISO 3691-1:2015, ISO 7405:2008/Amd 1:2013, EN ISO 7405:2008. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 7405:2008/A1:2013 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN ISO 7405:2008/A1:2013 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
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,
...