EN ISO 7405:2008/A1:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
29-01-2020
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Categorization of medical devices
5 Biological evaluation process
6 Test procedures specific to dental materials
Annex A (informative) - Types of test to be considered for
evaluation of biocompatibility of medical devices
used in dentistry
Annex B (informative) - Dentine barrier cytotoxicity test
Annex C (informative) - Acute toxicity testing
Bibliography
Describes test methods for the evaluation of biological effects of medical devices used in dentistry.
Committee |
TC 55
|
DevelopmentNote |
2008 Edition Re-Issued in July 2013 & incorporates AMD 1 2013. (08/2013)
|
DocumentType |
Test Method
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
DS EN ISO 7405 : 2009 AMD 1 2013 | Identical |
PN-EN ISO 7405:2019 | Identical |
PN EN ISO 7405 : 2009 AMD 1 2013 | Identical |
ISO 7405:2008 | Identical |
I.S. EN ISO 7405:2009 | Identical |
BS EN ISO 7405 : 2008 | Identical |
DIN EN ISO 7405:2013-12 | Identical |
ISO 7405:2018 | Identical |
NS EN ISO 7405 : 2018 | Identical |
UNE-EN ISO 7405:2009 | Identical |
ÖNORM EN ISO 7405 : 2019 | Identical |
NBN EN ISO 7405 : 2009 AMD 1 2013 | Identical |
NEN EN ISO 7405 : 2009 AMD 1 2013 | Identical |
NS EN ISO 7405 : 2008 AMD 1 2013 | Identical |
SN EN ISO 7405 : 2009 AMD 1 2013 | Identical |
NF EN ISO 7405 : 2009 AMD 1 2013 | Identical |
ONORM EN ISO 7405 : 2013 | Identical |
UNI EN ISO 7405 : 2013 | Identical |
I.S. EN ISO 7405:2018 | Identical |
08/30184612 DC : DRAFT SEP 2008 | BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
02/563845 DC : DRAFT SEP 2002 | BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
DIN EN 1642:2012-06 | Dentistry - Medical devices for dentistry - Dental implants |
CEN/TR 12401:2009 | Dentistry - Guidance on the classification of dental devices and accessories |
CR 12401 : 1996 | DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
S.R. CEN TR 12401:2009 | DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
DIN EN 1641:2010-02 | Dentistry - Medical devices for dentistry - Materials |
I.S. EN 1642:2011 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
I.S. EN 1641:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
UNI EN 1642 : 2012 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
08/30184615 DC : DRAFT SEP 2008 | BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
UNI EN 1641 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
PD CEN/TR 12401:2009 | Dentistry. Guidance on the classification of dental devices and accessories |
I.S. EN ISO 1564:1999 | DENTAL AQUEOUS IMPRESSION MATERIALS BASED ON AGAR |
02/563832 DC : DRAFT SEP 2002 | BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
UNE-EN 1642:2012 | Dentistry - Medical devices for dentistry - Dental implants |
ISO 1564:1995 | Dental aqueous impression materials based on agar |
BS EN 1641:2004 | Dentistry. Medical devices for dentistry. Materials |
EN ISO 1564:1998 | Dental aqueous impression materials based on agar (ISO 1564:1995) |
EN 1641:2009 | Dentistry - Medical devices for dentistry - Materials |
EN 1642:2011 | Dentistry - Medical devices for dentistry - Dental implants |
PD CR 12401:2003 | Dentistry. Guidance on the classification of dental devices and accessories |
BS EN 1642:2011 | Dentistry. Medical devices for dentistry. Dental implants |
BS EN ISO 1564:1999 | Dental aqueous impression materials based on agar |
ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
ISO 10993-18:2005 | Biological evaluation of medical devices Part 18: Chemical characterization of materials |
ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
ISO 1942:2009 | Dentistry Vocabulary |
ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
ADA 41 : 2015 | EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
ISO 6344-1:1998 | Coated abrasives Grain size analysis Part 1: Grain size distribution test |
ISO 14971:2007 | Medical devices Application of risk management to medical devices |
ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
ISO/TS 22911:2016 | Dentistry Preclinical evaluation of dental implant systems Animal test methods |
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