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PD ISO/TR 37137:2014
Действует
Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants
— 26 стр.
Описание
Изменения
Ссылки
Версии
Ссылочные документы
ISO 10993-1:2009
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
— 28 стр.
ISO 10993-2:2006
Действует
Biological evaluation of medical devices -- Part 2: Animal welfare requirements
— 20 стр.
ISO 10993-3:2003
Заменен
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
— 23 стр.
ISO 10993-4:2002
Заменен
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
— 40 стр.
ISO 10993-5:2009
Действует
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
— 42 стр.
ISO 10993-6:2007
Заменен
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
— 28 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 10993-10:2010
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 10993-12:2012
Действует
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
— 28 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 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.
ISO/TS 10993-19:2006
Действует
Biological evaluation of medical devices -- Part 19: Physicochemical, morphological and topographical characterization of materials
— 22 стр.
ISO/TS 10993-20:2006
Действует
Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
— 24 стр.
ISO/TR 15499:2012
Заменен
Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
— 22 стр.