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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008)
Hardcopy , PDF
English
12-02-2009
10-01-2019
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.
Dates of withdrawal of national standards are available from NSAI.
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Superseded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 |
| 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 |
| 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 |
| DIN EN ISO 7405:2009-06 | Equivalent |
| UNE-EN ISO 7405:2009 | Identical |
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