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DIN EN ISO 20857:2013-08

Действует
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013 — 72 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

DIN EN ISO 11140-1:2009-09
Отменен
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2009 — 39 стр.
DIN EN ISO 11607-1:2009-09
Отменен
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2009 — 34 стр.
DIN EN ISO 11607-2:2006-07
Отменен
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006); German version EN ISO 11607-2:2006 — 18 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 13485:2012-11
Отменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012 — 86 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 14971:2013-04
Отменен
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012 — 112 стр.
DIN EN ISO 15883-1:2009-09
Отменен
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006); German version EN ISO 15883-1:2009 — 89 стр.
DIN EN ISO 17664:2004-07
Отменен
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004); German version EN ISO 17664:2004 — 23 стр.
DIN EN ISO 18472:2006-10
Отменен
Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006); German version EN ISO 18472:2006 — 34 стр.
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.
DIN EN 556-1 Berichtigung 1:2006-12
Действует
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1:2001/AC:2006 — 2 стр.
DIN EN ISO 9001 Berichtigung 1:2009-12
Отменен
Quality management systems - Requirements (ISO 9001:2008); Trilingual version EN ISO 9001:2008, Corrigendum to DIN EN ISO 9001:2008-12; Trilingual version EN ISO 9001:2008/AC:2009 — 20 стр.
DIN EN ISO 9000:2005-12
Отменен
Quality management systems - Fundamentals and vocabulary (ISO 9000:2005); Trilingual version EN ISO 9000:2005 — 68 стр.
DIN EN ISO 10993-12:2012-10
Действует
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012 — 33 стр.
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)
DIN EN ISO 11138-1 Berichtigung 1:2008-08
Отменен
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006); German version EN ISO 11138-1:2006, Corrigendum to DIN EN ISO 11138-1:2006-09 — 5 стр.
ÖNORM EN ISO 11138-4:2006-10
Заменен
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2006)
DIN EN ISO 11140-1:2012-09
Отменен
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO/DIS 11140-1:2012); German version prEN ISO 11140-1:2012
BS ISO 11140-5:2007
Действует
Sterilization of health care products. Chemical indicators. Class 2 indicators for Bowie and Dick-type air removal tests — 22 стр.
DIN EN ISO 11607-1/A1:2013-04
Отменен
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006/DAM 1:2013); German version EN ISO 11607-1:2009/prA1:2013
DIN EN ISO 11607-2/A1:2013-04
Отменен
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/DAM 1:2013); German version EN ISO 11607-2:2006/prA1:2013
ÖNORM EN ISO 11737-1:2011-01
Заменен
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006 + Cor 1:2007) (consolidated version)
DIN EN ISO 9001:2008-12
Отменен
Quality management systems - Requirements (ISO 9001:2008); Trilingual version EN ISO 9001:2008 — 91 стр.
ÖNORM EN ISO 11737-2:2010-04
Заменен
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)
DIN EN ISO 15883-1/A1:2012-03
Отменен
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 DAM1:2011); German version EN ISO 15883-1:2009/prA1:2012
ÖNORM EN ISO 22442-1:2008-04
Заменен
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)
ÖNORM EN ISO 22442-2:2008-04
Заменен
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)
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 90003:2004
Заменен
Software engineering. Guidelines for the application of ISO 9001:2000 to computer software — 64 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 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 11138-4:2006-09
Отменен
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2006); German version EN ISO 11138-4:2006 — 16 стр.
DIN EN ISO 20857:2012-10
Отменен
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version FprEN ISO 20857:2012

На этот документ ссылаются

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 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 11140-1:2015-03
Действует
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014 — 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 13408-1:2011-09
Отменен
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008); German version EN ISO 13408-1:2011 — 65 стр.
DIN EN ISO 11138-4:2017-07
Действует
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017); German version EN ISO 11138-4:2017 — 17 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 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 17664:2018-04
Отменен
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017); German version EN ISO 17664:2017 — 36 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 16672:2015-12
Отменен
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015); German version EN ISO 16672:2015 — 25 стр.