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DIN EN ISO 25424:2011-09

Отменен
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009); German version EN ISO 25424:2011 — 52 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

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 867-5:2001-11
Действует
Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S; German version EN 867-5:2001 — 24 стр.
DIN EN 868-2:2017-05
Действует
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017 — 26 стр.
DIN EN 868-3:2017-05
Действует
Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods; German version EN 868-3:2017 — 22 стр.
DIN EN 868-4:2017-05
Действует
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017 — 18 стр.
DIN EN 868-5:2019-03
Действует
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods; German version EN 868-5:2018 — 23 стр.
DIN EN 868-6:2017-05
Действует
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2017 — 23 стр.
DIN EN 868-7:2017-05
Действует
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2017 — 30 стр.
DIN EN 868-8:2019-03
Действует
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German version EN 868-8:2018 — 21 стр.
ÖNORM EN 868-9:2019-04
Действует
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
ÖNORM EN 868-10:2019-04
Действует
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
DIN EN 14180:2014-09
Действует
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014 — 69 стр.
OVE EN 61010-2-040:2016-07
Действует
Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (IEC 61010-2-040:2015) (english version)
DIN EN ISO 9000:2015-11
Действует
Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 — 104 стр.
DIN EN ISO 10993-18:2021-03
Действует
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020 — 96 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 11138-1:2017-07
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.
DIN EN ISO 11138-5:2017-07
Действует
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017); German version EN ISO 11138-5:2017 — 16 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 11140-3:2009-09
Действует
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007); German version EN ISO 11140-3:2009 — 30 стр.
DIN EN ISO 11140-4:2007-07
Действует
Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007); German version EN ISO 11140-4:2007 — 43 стр.
DIN EN ISO 11607-1:2020-05
Действует
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020 — 60 стр.
DIN EN ISO 11607-2:2020-05
Действует
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020 — 23 стр.
DIN EN ISO 11737-1/A1:2019-06
Проект
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/DAM 1:2019); German and English version EN ISO 11737-1:2018/prA1:2019
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 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
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 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) — 54 стр.
DIN EN ISO 15883-1:2021-01
Проект
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO/DIS 15883-1:2020); German and English version prEN ISO 15883-1:2020
ÖNORM EN ISO 15883-2:2009-11
Действует
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)
ÖNORM EN ISO 15883-3:2009-11
Действует
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
ÖNORM EN ISO 15883-4:2019-06
Действует
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
DIN EN ISO 15883-6:2016-04
Действует
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011); German version EN ISO 15883-6:2015 — 22 стр.
DIN EN ISO 17664-1:2021-02
Отменен
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO/FDIS 17664-1:2020); German and English version prEN ISO 17664-1:2021 — 38 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.
ISO/TS 11139:2006
Заменен
Sterilization of health care products -- Vocabulary — 20 стр.
DIN EN ISO 25424:2020-05
Действует
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018); German version EN ISO 25424:2019 — 69 стр.
DIN EN 15424:2007-08
Отменен
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices; German version EN 15424:2007 — 51 стр.
DIN EN ISO 25424:2010-12
Отменен
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009); German version FprEN ISO 25424:2010

На этот документ ссылаются

DIN EN 14180:2014-09
Действует
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014 — 69 стр.
DIN EN 15424:2007-08
Отменен
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices; German version EN 15424:2007 — 51 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 12182:2012-07
Действует
Assistive products for persons with disability - General requirements and test methods; German version EN 12182:2012 — 66 стр.
DIN ISO 5294:1996-05
Отменен
Synchronous belt drives - Pulleys; Identical with ISO 5294:1989 — 12 стр.
DIN 58948-17:2016-10
Действует
Sterilization - Low temperature sterilizers - Part 17: Requirements for the installation and operation of low temperature steam formaldehyde and formaldehyde sterilizers and their supply sources — 28 стр.
DIN 58948-17:2016-04
Отменен
Sterilization - Low temperature sterilizers - Part 17: Requirements for the installation and operation of low temperature steam formaldehyde and formaldehyde sterilizers and their supply sources — 28 стр.
DIN EN ISO 11138-5:2017-07
Действует
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017); German version EN ISO 11138-5:2017 — 16 стр.
DIN EN ISO 25424:2020-05
Действует
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018); German version EN ISO 25424:2019 — 69 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.