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I.S. EN ISO 7405:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 7405:2008)
Available format(s)

Hardcopy , PDF

Superseded date

01-10-2019

Language(s)

English

Published date

02-12-2009

Preview

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) - 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Superseded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

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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