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I.S. EN ISO 7405:2018

Superseded

Superseded

View Superseded by

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-17-2018

Superseded date

01-29-2020

US$114.00
Excluding Tax where applicable

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.

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 document specifies test methods for the evaluation of biological effects of medical devices used in dentistry.

Committee
TC 106
DocumentType
Test Method
Pages
0
ProductNote
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 7405:2018 Identical
EN ISO 7405:2018 Identical
BS EN ISO 7405:2018 Equivalent

US$114.00
Excluding Tax where applicable