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BS EN ISO 7198:2017

Действует
Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches — 68 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 25539-2:2012
Действует
Cardiovascular implants -- Endovascular devices -- Part 2: Vascular stents — 98 стр.
ISO 25539-1:2003/Amd.1:2005
Заменен
Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses -- Amendment 1: Test methods — 50 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO 12417-1:2015
Действует
Cardiovascular implants and extracorporeal systems -- Vascular device-drug combination products -- Part 1: General requirements — 56 стр.
ISO/TS 17665-2:2009
Действует
Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1 — 54 стр.
ISO 17665-1:2006
Действует
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices — 48 стр.
BS EN ISO 17665-1:2006
Действует
Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices — 52 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
BS EN ISO 14971:2012
Действует
Medical devices. Application of risk management to medical devices — 104 стр.
ISO 14937:2009
Действует
Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices — 46 стр.
BS EN ISO 14937:2009
Действует
Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices — 52 стр.
BS EN ISO 14630:2012
Действует
Non-active surgical implants. General requirements — 24 стр.
ISO 14630:2012
Действует
Non-active surgical implants -- General requirements — 20 стр.
ISO 14160:2011
Действует
Sterilization of health care products -- Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives -- Requirements for characterization, development, validation and routine control of a sterilization process for medical devices — 42 стр.
BS EN ISO 14160:2011
Действует
Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices — 44 стр.
ISO 14155:2011
Действует
Clinical investigation of medical devices for human subjects -- Good clinical practice — 66 стр.
BS EN ISO 14155:2011
Действует
Clinical investigation of medical devices for human subjects. Good clinical practice — 68 стр.
ISO 11607-1:2006
Действует
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems — 32 стр.
BS EN ISO 11607-1:2009
Действует
Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems — 34 стр.
ISO 11137-3:2006
Действует
Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects — 22 стр.
BS EN ISO 11137-3:2006
Заменен
Sterilization of health care products. Radiation. Guidance on dosimetric aspects — 28 стр.
ISO 11137-2:2013
Действует
Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose — 76 стр.
BS EN ISO 11137-2:2015
Действует
Sterilization of health care products. Radiation. Establishing the sterilization dose — 84 стр.
ISO 11137-1:2006
Действует
Sterilization of health care products -- Radiation -- Part 1: Requirements For development, validation and routine control of a sterilization process for medical devices — 44 стр.
BS EN ISO 11137-1:2015
Действует
Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices — 52 стр.
ISO 11135:2014
Действует
Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices — 88 стр.
BS EN ISO 11135:2014
Действует
Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices — 94 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/TS 10993-19:2006
Действует
Biological evaluation of medical devices -- Part 19: Physicochemical, morphological and topographical characterization of materials — 22 стр.
ISO 10993-18:2005
Действует
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials — 24 стр.
BS EN ISO 10993-18:2009
Действует
Biological evaluation of medical devices. Chemical characterization of materials — 28 стр.
ISO 10993-17:2002
Действует
Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances — 31 стр.
BS EN ISO 10993-17:2009
Действует
Biological evaluation of medical devices. Establishment of allowable limits for leachable substances — 36 стр.
ISO 10993-16:2010
Заменен
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables — 18 стр.
BS EN ISO 10993-16:2010
Заменен
Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables — 22 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.
BS EN ISO 10993-15:2009
Действует
Biological evaluation of medical devices. Identification and quantification of degradation products from metals and alloys — 22 стр.
ISO 10993-14:2001
Действует
Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics — 18 стр.
BS EN ISO 10993-14:2009
Действует
Biological evaluation of medical devices. Identification and quantification of degradation products from ceramics — 22 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.
BS EN ISO 10993-13:2010
Действует
Biological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices — 26 стр.
ISO 10993-12:2012
Действует
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials — 28 стр.
BS EN ISO 10993-12:2012
Действует
Biological evaluation of medical devices. Sample preparation and reference materials — 32 стр.
ISO 10993-11:2006
Заменен
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 34 стр.
BS EN ISO 10993-11:2009
Заменен
Biological evaluation of medical devices. Tests for systemic toxicity — 38 стр.
ISO 10993-10:2010
Действует
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization — 74 стр.
BS EN ISO 10993-10:2013
Действует
Biological evaluation of medical devices. Tests for irritation and skin sensitization — 78 стр.
ISO 10993-9:2009
Действует
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products — 16 стр.
BS EN ISO 10993-9:2009
Действует
Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products — 20 стр.
ISO 10993-7:2008
Действует
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals — 94 стр.
BS EN ISO 10993-7:2008
Действует
Biological evaluation of medical devices. Ethylene oxide sterilization residuals — 98 стр.
ISO 10993-6:2007
Заменен
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation — 28 стр.
BS EN ISO 10993-6:2009
Заменен
Biological evaluation of medical devices. Tests for local effects after implantation — 32 стр.
ISO 10993-5:2009
Действует
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity — 42 стр.
BS EN ISO 10993-5:2009
Действует
Biological evaluation of medical devices. Tests for in vitro cytotoxicity — 46 стр.
ISO 10993-4:2002
Заменен
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood — 40 стр.
BS EN ISO 10993-4:2009
Заменен
Biological evaluation of medical devices. Selection of tests for interactions with blood — 46 стр.
ISO 10993-3:2014
Действует
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity — 42 стр.
BS EN ISO 10993-3:2014
Действует
Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity — 46 стр.
ISO 10993-2:2006
Действует
Biological evaluation of medical devices -- Part 2: Animal welfare requirements — 20 стр.
BS EN ISO 10993-2:2006
Действует
Biological evaluation of medical devices. Animal welfare requirements — 24 стр.
ISO 10993-1:2009
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.
BS EN ISO 10993-1:2009
Заменен
Biological evaluation of medical devices. Evaluation and testing within a risk management process — 32 стр.
BS EN 12006-2:1998+A1:2009
Заменен
Non active surgical implants. Particular requirements for cardiac and vascular implants, Vascular prostheses including cardiac valve conduits — 16 стр.
BS ISO 7198:1998
Заменен
Cardiovascular implants. Tubular vascular prostheses — 56 стр.

На этот документ ссылаются

BS ISO 7198:1998
Заменен
Cardiovascular implants. Tubular vascular prostheses — 56 стр.
BS EN 12006-2:1998+A1:2009
Заменен
Non active surgical implants. Particular requirements for cardiac and vascular implants, Vascular prostheses including cardiac valve conduits — 16 стр.