BS EN ISO 7405 : 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
Hardcopy , PDF
28-11-2018
English
01-01-2008
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 |
CH/106
|
DevelopmentNote |
Supersedes BS 5828(1989) & 07/30163763 DC. (01/2009) 2008 Edition Re-Issued in August 2013 & incorporates AMD 1 2013. Supersedes 12/30256259 DC. (08/2013)
|
DocumentType |
Standard
|
Pages |
44
|
PublisherName |
British Standards Institution
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
ISO 7405:2008 | 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 |
I.S. EN ISO 7405:2009 | Identical |
SN EN ISO 7405 : 2009 AMD 1 2013 | Identical |
UNI EN ISO 7405 : 2013 | Identical |
UNE-EN ISO 7405:2009 | Identical |
NF EN ISO 7405 : 2009 AMD 1 2013 | Identical |
DIN EN ISO 7405:2013-12 | Identical |
ONORM EN ISO 7405 : 2013 | Identical |
EN ISO 7405:2018 | Identical |
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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