I.S. EN ISO 7405:2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 7405:2018)
Hardcopy , PDF
29-01-2020
English
17-12-2018
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) Endosseous dental implant usage test
Bibliography
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