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BS EN ISO 7405:2008+A1:2013

Действует
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry — 44 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 6344-1:1998
Действует
Coated abrasives - Grain size analysis - Part 1: Grain size distribution test — 8 стр.
ISO 10993-1:2009
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.
ISO 10993-5:2009
Действует
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity — 42 стр.
ISO 10993-6:2016
Действует
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation — 36 стр.
ISO 19426-5:2018
Действует
Structures for mine shafts -- Part 5: Shaft system structures — 46 стр.
ISO 10993-2:2006
Действует
Biological evaluation of medical devices -- Part 2: Animal welfare requirements — 20 стр.
ISO 10993-3:2014
Действует
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity — 42 стр.
ISO 10993-10:2010
Действует
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization — 74 стр.
ISO 10993-11:2006
Заменен
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 34 стр.
ISO 10993-13:2010
Действует
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices — 22 стр.
ISO 10993-14:2001
Действует
Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics — 18 стр.
ISO/TS 22911:2005
Заменен
Dentistry -- Preclinical evaluation of dental implant systems -- Animal test methods — 12 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ISO 10993-7:2008
Действует
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals — 94 стр.
ISO 10993-9:2009
Действует
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products — 16 стр.
ISO 10993-15:2000
Действует
Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys — 20 стр.
ISO 10993-16:2010
Заменен
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables — 18 стр.
ISO 10993-17:2002
Действует
Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances — 31 стр.
ISO 10993-18:2005
Действует
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials — 24 стр.
BS EN ISO 7405:2008
Действует
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry — 44 стр.

На этот документ ссылаются

BS EN ISO 7405:1997
Заменен
Dentistry. Preclinical evaluation of biocompatibility of medical devices used in dentistry. Test methods for dental materials — 24 стр.
BS EN ISO 7405:2018
Действует
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry — 52 стр.