BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

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

BS EN ISO 7405.

Committee	CH/106
DocumentType	Draft
Pages	51
PublisherName	British Standards Institution
Status	NA

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
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/TS 10993-19:2006	Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical 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 16443:2014	Dentistry Vocabulary for dental implants systems and related procedure
ISO 10993-9:2009	Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 14801:2016	Dentistry Implants Dynamic loading test for endosseous dental implants
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/TR 15499:2016	Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process
ISO 10993-6:2016	Biological evaluation of medical devices Part 6: Tests for local effects after implantation