Каталог стандартов

+7 (495) 223-46-76 +7 (812) 309-78-59
inform@normdocs.ru
О компании Стандарты Контакты Заказать стандарт
СтандартыDIN

DIN EN ISO 14160:2011-10

Отменен
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 (ISO 14160:2011); German version EN ISO 14160:2011 — 48 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

DIN EN ISO 9004:2009-12
Отменен
Managing for the sustained success of an organization - A quality management approach (ISO 9004:2009); Trilingual version EN ISO 9004:2009 — 140 стр.
DIN EN ISO 10012:2004-03
Действует
Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003 — 56 стр.
DIN EN ISO 10993-1:2010-04
Отменен
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009 — 35 стр.
DIN EN ISO 10993-17:2009-08
Действует
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2009 — 38 стр.
DIN EN ISO 11135-1:2007-08
Отменен
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); German version EN ISO 11135-1:2007 — 52 стр.
DIN EN ISO 11137-1:2006-07
Отменен
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006); German version EN ISO 11137-1:2006 — 49 стр.
DIN EN ISO 11138-1:2006-09
Отменен
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006); German version EN ISO 11138-1:2006 — 48 стр.
DIN EN ISO 11737-1:2009-09
Отменен
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006); German version EN ISO 11737-1:2006 + AC:2009 — 48 стр.
DIN EN ISO 11737-2:2010-04
Отменен
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009); German version EN ISO 11737-2:2009 — 28 стр.
DIN EN ISO 13485:2010-01
Отменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009 — 75 стр.
DIN EN ISO 14161:2010-03
Отменен
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009); German version EN ISO 14161:2009 — 79 стр.
DIN EN ISO 17665-1:2006-11
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 (ISO 17665-1:2006); German version EN ISO 17665-1:2006 — 51 стр.
ÖNORM EN ISO 14937:2010-03
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 (ISO 14937:2009)
DIN EN ISO 22442-1:2008-03
Отменен
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007); German version EN ISO 22442-1:2007 — 36 стр.
DIN EN ISO 22442-2:2008-03
Отменен
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007); German version EN ISO 22442-2:2007 — 23 стр.
DIN EN ISO 22442-3:2008-03
Действует
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007 — 31 стр.
ÖNORM EN 556-1:2006-12
Действует
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices (consolidated version)
ÖNORM EN ISO 9004:2018-10
Действует
Quality management - Quality of an organization - Guidance to achieve sustained success (ISO 9004:2018)
DIN EN ISO 10993-18/A1:2021-10
Проект
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/DAM 1:2021); German and English version EN ISO 10993-18:2020/prA1:2021
ÖNORM EN ISO 10993-17:2009-09
Действует
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
ÖNORM EN ISO 11137-1:2020-04
Действует
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd.1:2013 + Amd.2:2018) (consolidated version)
DIN EN ISO 11138-1:2017-07
Действует
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017); German version EN ISO 11138-1:2017 — 52 стр.
ISO/TS 11139:2006
Заменен
Sterilization of health care products -- Vocabulary — 20 стр.
DIN EN ISO 11737-2:2020-07
Действует
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020 — 43 стр.
DIN EN ISO 13408-1:2015-12
Действует
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013); German version EN ISO 13408-1:2015 — 70 стр.
DIN EN ISO 13408-2:2018-06
Действует
Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
ÖNORM EN ISO 13408-3:2011-09
Действует
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
DIN EN ISO 13408-4:2011-09
Действует
Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005); German version EN ISO 13408-4:2011 — 27 стр.
ÖNORM EN ISO 13408-5:2011-09
Действует
Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
DIN EN ISO 13408-6:2021-11
Действует
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021); German version EN ISO 13408-6:2021 — 45 стр.
DIN EN ISO 13485/A1:2019-11
Отменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
ÖNORM EN ISO 17665-1:2006-11
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 (ISO 17665-1:2006)
DIN EN ISO 22442-1:2021-08
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020 — 46 стр.
ÖNORM EN ISO 22442-2:2021-05
Действует
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
ÖNORM EN ISO 22442-3:2008-04
Действует
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
BS ISO/IEC 90003:2014
Действует
Software engineering. Guidelines for the application of ISO 9001:2008 to computer software — 64 стр.
DIN EN ISO 14160:2021-11
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 (ISO 14160:2020); German version EN ISO 14160:2021 — 59 стр.
DIN EN ISO 14160:1998-06
Отменен
Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998); German version EN ISO 14160:1998 — 22 стр.
DIN EN ISO 14160:2009-04
Отменен
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 (ISO/DIS 14160:2009); German version prEN ISO 14160:2009

На этот документ ссылаются

DIN EN 556-2:2004-03
Отменен
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003 — 10 стр.
DIN EN 556-2:2015-11
Действует
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 — 19 стр.
DIN EN ISO 5840:2009-08
Отменен
Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005); German version EN ISO 5840:2009 — 102 стр.
DIN EN ISO 13485:2010-01
Отменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009 — 75 стр.
DIN EN ISO 13408-1:2013-08
Отменен
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:2013); German version EN ISO 13408-1:2011 + A1:2013 — 64 стр.
DIN EN ISO 13408-1:2015-12
Действует
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013); German version EN ISO 13408-1:2015 — 70 стр.
DIN EN ISO 14630:2013-03
Действует
Non-active surgical implants - General requirements (ISO 14630:2012); German version EN ISO 14630:2012 — 23 стр.
DIN EN ISO 14160:1998-06
Отменен
Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998); German version EN ISO 14160:1998 — 22 стр.
DIN EN ISO 7198:2017-07
Действует
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016); German version EN ISO 7198:2017 — 76 стр.
DIN EN ISO 25539-1:2009-08
Отменен
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005); German version EN ISO 25539-1:2009 — 112 стр.
DIN EN ISO 11737-1:2018-07
Отменен
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018); German version EN ISO 11737-1:2018 — 75 стр.
DIN EN ISO 25539-2:2013-05
Отменен
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012); German version EN ISO 25539-2:2012 — 115 стр.
DIN EN ISO 5840-3:2013-06
Отменен
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013); German version EN ISO 5840-3:2013 — 122 стр.
DIN EN ISO 5840-1:2015-12
Отменен
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015); German version EN ISO 5840-1:2015 — 73 стр.
DIN EN ISO 11737-1:2018-11
Отменен
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018); German version EN ISO 11737-1:2018 — 76 стр.
DIN EN ISO 14160:2021-11
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 (ISO 14160:2020); German version EN ISO 14160:2021 — 59 стр.