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ÖNORM EN ISO 25539-1:2011-03

Заменен
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005) (consolidated version)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

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 10993-5:2009
Действует
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity — 42 стр.
ISO 10993-7:2008
Действует
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals — 94 стр.
ISO 10993-7:2008/Cor.1:2009
Действует
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals -- Technical Corrigendum 1 — 2 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 10993-17:2002
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 13485:2016
Действует
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 46 стр.
ISO 14155:2011
Действует
Clinical investigation of medical devices for human subjects -- Good clinical practice — 66 стр.
ISO 14155:2011/Cor.1:2011
Действует
Clinical investigation of medical devices for human subjects -- Good clinical practice -- Technical Corrigendum 1 — 1 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.
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.
ISO 10993-16:2017
Действует
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables — 36 стр.
ISO 10993-4:2017
Действует
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood — 76 стр.
ISO 10993-6:2016
Действует
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation — 36 стр.
ISO 10993-1:2009
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.
ISO 10993-1:2009/Cor.1:2010
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process -- Technical Corrigendum 1 — 1 стр.
ÖNORM EN ISO 25539-1:2017-09
Действует
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)
ÖNORM EN ISO 25539-1:2009-10
Отменен
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

На этот документ ссылаются

ÖNORM EN ISO 25539-1:2009-10
Отменен
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
ÖNORM EN ISO 25539-1:2017-09
Действует
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)