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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.
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На этот документ ссылаются

DD ISO/TS 12417:2011
Действует
Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products — 60 стр.
BS EN ISO 13408-1:2011+A1:2013
Заменен
Aseptic processing of health care products. General requirements — 60 стр.
BS EN ISO 5840:2009
Заменен
Cardiovascular implants. Cardiac valve prostheses — 96 стр.
PD ISO/TR 16142:2006
Заменен
Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices — 26 стр.
BS EN ISO 25539-1:2009
Заменен
Cardiovascular Implants. Endovascular devices. Endovascular prostheses — 96 стр.
BS EN ISO 7198:2017
Действует
Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches — 68 стр.
BS EN ISO 13408-1:2015
Действует
Aseptic processing of health care products. General requirements — 60 стр.
BS EN ISO 12417-1:2015
Действует
Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products. General requirements — 64 стр.
BS EN 556-2:2015
Действует
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices — 20 стр.
BS ISO 18362:2016
Действует
Manufacture of cell-based health care products. Control of microbial risks during processing — 46 стр.
BS ISO 16142-1:2016
Действует
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards — 60 стр.
PD ISO/TS 19930:2017
Действует
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 — 32 стр.
PD ISO/TR 22442-4:2010
Действует
Medical devices utilizing animal tissues and their derivatives. Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes — 24 стр.
PD ISO/TR 14283:2018
Действует
Implants for surgery. Essential principles of safety and performance — 28 стр.
18/30338923 DC
Действует
BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process — 30 стр.
BS EN ISO 25539-1:2017
Действует
Cardiovascular implants. Endovascular devices. Endovascular prostheses — 138 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 11737-2:2009
Действует
Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process — 28 стр.
BS EN ISO 22442-3:2007
Действует
Medical devices utilizing animal tissues and their derivatives. Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents — 34 стр.
BS EN ISO 22803:2005
Действует
Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file — 16 стр.
BS ISO 5910:2018
Действует
Cardiovascular implants and extracorporeal systems. Cardiac valve repair devices — 134 стр.
BS EN ISO 22794:2009
Действует
Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file — 20 стр.
BS EN ISO 11737-1:2018
Действует
Sterilization of health care products. Microbiological methods. Determination of a population of microorganisms on products — 64 стр.
18/30375452 DC
Действует
BS EN ISO 22442-1. Medical devices utilizing animal tissues and their derivatives. Part 1. Application of risk management — 35 стр.
BS EN ISO 22442-1:2015
Действует
Medical devices utilizing animal tissues and their derivatives. Application of risk management — 38 стр.
BS EN ISO 14630:2012
Действует
Non-active surgical implants. General requirements — 24 стр.
BS ISO 27427:2013
Действует
Anaesthetic and respiratory equipment. Nebulizing systems and components — 58 стр.
BS EN ISO 25539-2:2012
Действует
Cardiovascular implants. Endovascular devices. Vascular stents — 100 стр.
BS EN ISO 5840-2:2015
Действует
Cardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes — 64 стр.
BS EN ISO 5840-3:2013
Действует
Cardiovascular implants. Cardiac valve prostheses. Heart valve substitutes implanted by transcatheter techniques — 116 стр.
BS EN ISO 5840-1:2015
Действует
Cardiovascular implants. Cardiac valve prostheses. General requirements — 66 стр.
ÖNORM EN ISO 13408-1:2014-01
Заменен
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:2013) (consolidated version)
ÖNORM EN ISO 5840:2009-09
Заменен
Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
ÖNORM EN ISO 25539-2:2013-06
Заменен
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
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)
ÖNORM EN ISO 13408-1:2015-11
Действует
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
ÖNORM EN ISO 14630:2013-04
Действует
Non-active surgical implants - General requirements (ISO 14630:2012)
ÖNORM EN ISO 5840-1:2015-12
Заменен
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
ÖNORM EN ISO 5840-3:2013-06
Заменен
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
ÖNORM EN ISO 5840-1:2021-07
Действует
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)
ÖNORM EN ISO 7198:2017-06
Действует
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
ÖNORM EN ISO 25539-1:2017-09
Действует
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)
ÖNORM EN ISO 25539-2:2021-03
Действует
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)