I.S. EN ISO 7405:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
10-01-2019
English
12-02-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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 106
|
| DocumentType |
Test Method
|
| Pages |
48
|
| ProductNote |
THIS STANDARD ALSO REFERS TO :ANSI/ADA Specification No. 41
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN ISO 7405:2008 | Identical |
| SN EN ISO 7405 : 2009 AMD 1 2013 | Identical |
| NF EN ISO 7405 : 2009 AMD 1 2013 | Identical |
| ISO 7405:2008 | Identical |
| BS EN ISO 7405 : 2008 | Identical |
| DIN EN ISO 7405:2013-12 | Identical |
| ONORM EN ISO 7405 : 2013 | Identical |
| UNI EN ISO 7405 : 2013 | Identical |
| UNE-EN ISO 7405:2009 | 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 |
| 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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