I.S. EN ISO 7405:2018&LC:2018
Current
The latest, up-to-date edition.
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
Hardcopy , PDF
English
16-01-2019
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.
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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) Endosseous dental implant usage test
Bibliography
This International Standard specifies test methods for the evaluation of biological effects of medical devices used in dentistry.
| Committee |
TC 106
|
| DocumentType |
Test Method
|
| Pages |
62
|
| ProductNote |
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 7405:2018 | Identical |
| EN ISO 7405:2018 | Identical |
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