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Sterilization vapor testing

Sterilization vapor testing, Total:287 items.

In the international standard classification, Sterilization vapor testing involves: Sterilization and disinfection, Pharmaceutics, Vocabularies, Agricultural machines, implements and equipment, Aids for disabled or handicapped persons, Biology. Botany. Zoology, Microbiology, Plant and equipment for the food industry, Equipment for the chemical industry.

British Standards Institution (BSI), Sterilization vapor testing

BS EN ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
BS EN 285:2015+A1:2021 Sterilization. Steam sterilizers. Large sterilizers
BS EN 13060:2004+A1:2009 Small steam sterilizers
BS EN 13060:2004+A2:2010 Small steam sterilizers
BS EN 13060:2014 Small steam sterilizers
BS EN 13060:2014+A1:2018 Small steam sterilizers
BS EN 13060:2005 Small steam sterilizers
BS EN 13060:2004 Small steam sterilizers
BS EN 13060+A2:2005 Small steam sterilizers
BS EN 13060+A1:2005 Small steam sterilizers
18/30379433 DC BS EN 285 AMD1. Sterilization. Steam sterilizers. Large sterilizers
BS EN 14180:2003+A2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
BS EN 14180:2014 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
BS EN 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
23/30458211 DC BS EN 14180. Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers.Requirements and testing
BS EN 868-8:2018 Tracked Changes. Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
BS EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
BS EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Biological indicators for low-temperature steam and formaldehyde sterilization processes
BS EN ISO 11138-8:2021 Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes
BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN 868-8:2009 Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods
BS EN ISO 25424:2019+A1:2022 Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN ISO 11138-5:2017 Tracked Changes. Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes
PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat. Guidance on the designation of a medical device to a product family and processing category for steam sterilization
BS EN ISO 11140-6:2022 Tracked Changes. Sterilization of health care products. Chemical indicators. Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
21/30327620 DC BS EN ISO 11140-6. Sterilization of health care products. Chemical indicators. Part 6. Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
BS 3970-5:1990 Sterilizing and disinfecting equipment for medical products - Specification for low temperature steam disinfectors
23/30457222 DC BS EN 17180. Sterilizers for medical purposes. Low temperature vapourized hydrogen peroxide sterilizers. Requirements and testing
17/30364306 DC BS EN 17180. Sterilizers for medical purposes. Low temperature vaporized hydrogen peroxide sterilizers. Requirements and testing
21/30427336 DC BS EN ISO 25424 AMD1. Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
BS 3970-6:1993 Sterilizing and disinfecting equipment for medical products - Specification for sterilizers using low-temperature steam with formaldehyde
BS ISO 11737-3:2023 Sterilization of health care products. Microbiological methods. Bacterial endotoxin testing

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Sterilization vapor testing

GB/T 8600-1988 Inspecting method for sterilizing effect of automated autoclave sterilizer
GB 8600-1988 Inspecting method for sterilizing effect of automated autoclave sterilizer
GB/T 30690-2014 Monitoring requirements and evaluation of sterilization effect of small steam sterilizer
GB 8599-2023 Technical requirements for large pressure steam sterilizers
GB 8599-1988 Specifications for automated autoclave sterilizer
GB 8599-2008 Technical requirements for large steam sterilizers.Automatic type
GB 18281.5-2015 Biological indicators for sterilization of healthcare products - Part 5: Biological indicators for formaldehyde sterilization by low temperature steam

Association Francaise de Normalisation, Sterilization vapor testing

NF S98-011*NF EN 285:2015+A1:2021:2021 Sterilization - Steam sterilizers - Large sterilizers
NF S98-011/IN1*NF EN 285/IN1:2021 Sterilization - Steam sterilizers - Large sterilizers
NF S98-011*NF EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
NF EN 285/IN1:2021 Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs
NF S98-020:2010 Small steam sterilizers.
NF S98-020/IN2:2010 Small steam sterilizers.
NF S98-020:2015 Small steam sterilizers
NF S98-020*NF EN 13060+A1:2018 Small steam sterilizers
NF S98-020/IN1*NF EN 13060/IN1:2018 Small steam sterilizers
NF EN 13060+A1:2018 Petits stérilisateurs à la vapeur d'eau
NF EN 13060/IN1:2018 Petits stérilisateurs à la vapeur d'eau
NF EN 14180:2014 Stérilisateurs à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse température - Exigences et essais
NF S98-012:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing.
NF S98-012*NF EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
NF S98-105:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat.
NF EN 12347:1998 Biotechnologie - Équipement - Critères de performance pour les stérilisateurs à la vapeur d'eau et les autoclaves
NF S98-051-8:2009 Packaging for terminally sterilized medical devices - Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods.
GA S98-130:2002 Sterilisation of medical devices - Interpretation guide for NF EN 554 intended for health establishments - Validation and routine inspection for steam sterilisation (October 1994)
NF S98-051-8*NF EN 868-8:2018 Packaging for terminally sterilized medical devices - Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
NF EN 868-8:2018 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 8 : conteneurs réutilisables de stérilisation pour stérilisateurs à la vapeur d'eau conformes à l'EN 285 - Exigences et méthodes d'essai
NF S98-001-4*NF EN ISO 11140-4:2007 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.
NF EN ISO 11138-5:2017 Stérilisation des produits de santé - Indicateurs biologiques - Partie 5 : indicateurs biologiques pour la stérilisation à la vapeur d'eau et au formaldéhyde à basse température
NF S98-004-5*NF EN ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5 : biological indicators for low-temperature steam and formaldehyde sterilization processes
NF S98-012/IN2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing.
NF EN ISO 25424:2019 Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température - Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux
NF ISO 22441:2022 Stérilisation des produits de santé - Vapeur de peroxyde d'hydrogène à basse température - Exigences pour la mise au point, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux
NF EN ISO 11140-6:2022 Stérilisation des produits de santé - Indicateurs chimiques - Partie 6 : indicateurs de type 2 et dispositifs d'épreuve de procédé destinés à être utilisés pour les essais de performances relatifs aux petits stérilisateurs à la vapeur d'eau
NF S98-004-5:2006 Sterilization of health care products - Biological indicators - Part 5 : biological indicators for low-temperature steam and formaldehyde sterilization processes.
NF EN ISO 25424/A1:2022 Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température - Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux - Amendement 1
NF EN ISO 18472:2018 Stérilisation des produits de santé - Indicateurs biologiques et chimiques - Appareillage d'essai
NF EN ISO 11140-4:2007 Stérilisation des produits de santé - Indicateurs chimiques - Partie 4 : indicateurs de classe 2 comme alternative à l'essai de Bowie et Dick pour la détection de la pénétration de la vapeur

AENOR, Sterilization vapor testing

UNE-EN 285:2007+A2:2009 Sterilization - Steam sterilizers - Large sterilizers
UNE-EN 13060:2015 Small steam sterilizers
UNE-EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
UNE-EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
UNE-EN 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
UNE-EN ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
UNE-EN ISO 25424:2011 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)

European Committee for Standardization (CEN), Sterilization vapor testing

CEN EN 285-2006 Sterilization - Steam Sterilizers - Large Sterilizers
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
EN 285:1996 Sterilization - Steam Sterilizers - Large Sterilizers
EN 285:2015+A1:2021 Sterilization - Steam sterilizers - Large sterilizers
EN 866-5:1999 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 5: Particular Systems for Use in Low Temperature Steam and Formaldehyde Sterilizers
EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
EN 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing Incorporates Amendment A2: 2009
EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dicktype test for detection of steam penetration
EN ISO 25424:2019 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)
prEN ISO 11140-4 rev 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
EN ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
prEN ISO 11140-6:2021 Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO/DIS 11140-6:2021)
EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
EN ISO 11140-6:2022 Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)
EN ISO 25424:2019/prA1:2021 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/DAM 1:2021)
EN ISO 25424:2019/A1:2022 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)

Danish Standards Foundation, Sterilization vapor testing

DS/EN 285+A2:2009 Sterilization - Steam sterilizers - Large sterilizers
DS/EN 285:2021 Sterilization – Steam sterilizers – Large sterilizers
DS/EN 13060+A2:2010 Small steam sterilizers
DS/EN 14180+A2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
DS/EN 12347:1998 Biotechnology - Performance criteria for steam sterilizers and autoclaves
DS/EN 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
DS/EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
DS/EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 11140-4:2007 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

Lithuanian Standards Office , Sterilization vapor testing

LST EN 285-2006+A2-2009 Sterilization - Steam sterilizers - Large sterilizers
LST EN 13060-2004+A2-2010 Small steam sterilizers
LST EN 14180-2004+A2-2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
LST EN 12347-2000 Biotechnology - Performance criteria for steam sterilizers and autoclaves
LST EN 868-8-2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
LST EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006)
LST EN ISO 25424:2011 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 Institute for Standardization, Sterilization vapor testing

DIN EN 285/A1:2018 Sterilization - Steam sterilizers - Large sterilizers; German and English version EN 285:2015/prA1:2018
DIN EN 285:2021-12 Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015+A1:2021
DIN 58950-3:2021-06 Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English / Note: DIN 58950-3 (2011-01) remains valid alongside this standard until 2022-06-01.
DIN EN 13060:2019-02 Small steam sterilizers; German version EN 13060:2014+A1:2018
DIN EN 13060:2023-05 Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing; German and English version prEN 13060:2023 / Note: Date of issue 2023-04-21*Intended as replacement for DIN EN 13060 (2019-02).
DIN EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015
DIN 58950-1:2022 Sterilization - Steam sterilizers for pharmaceutical products - Part 1: Terminology; Text in German and English
DIN 58950-3:2021 Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English
DIN 58950-6:2019 Sterilization - Steam sterilizers for pharmaceutical products - Part 6: Operation; Text in German and English
DIN 58950-3:2020 Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English
DIN 58950-6:2019-03 Sterilization - Steam sterilizers for pharmaceutical products - Part 6: Operation; Text in German and English / Note: DIN 58950-6 (2011-01) remains valid alongside this standard until 2019-08-31.
DIN 58950-1:2022-06 Sterilization - Steam sterilizers for pharmaceutical products - Part 1: Vocabulary; Text in German and English
DIN EN 285:2021 Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015+A1:2021
DIN EN 14180:2023 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German and English version prEN 14180:2023
DIN EN 14180:2023-04 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German and English version prEN 14180:2023 / Note: Date of issue 2023-03-24*Intended as replacement for DIN EN 14180 (2014-09).
DIN EN 14180:2014-09 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014
DIN 58950-2:2020 Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English
DIN 58950-2:2021 Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English
DIN 58950-2:2021-06 Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English / Note: DIN 58950-2 (2011-01) remains valid alongside this standard until 2022-06-01.
DIN 58946-7:2014-01 Sterilization - Steam sterilizers - Part 7: Edificial preconditions, requirements for the services and the operation of steam sterilizers used in health care facilities
DIN EN 12347:1998-06 Biotechnology - Performance criteria for steam sterilizers and autoclaves; German version EN 12347:1998
DIN EN 13060:2019 Small steam sterilizers (includes Amendment :2018)
DIN EN 285:2009 Sterilization - Steam sterilizers - Large sterilizers (includes Amendment A2:2009); English version of DIN EN 285:2009-08
DIN 58950-7:2022-06 Sterilization - Steam sterilizers for pharmaceutical products - Part 7: Requirements on services and local environment; Text in German and English / Note: DIN 58950-7 (2011-01) remains valid alongside this standard until 2023-05-31.
DIN EN 13060:2023 Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing; German and English version prEN 13060:2023
DIN EN 13060:2015 Small steam sterilizers; German version EN 13060:2014
DIN 58950-7:2022 Sterilization - Steam sterilizers for pharmaceutical products - Part 7: Requirements on services and local environment; Text in German and English
DIN EN 13060 Berichtigung 1:2007 Small steam sterilizers; German version EN 13060:2004, Corrigenda to DIN EN 13060:2004-09
DIN 58951-2:2003 Sterilization - Steam sterilizers for laboratory use - Part 2: Apparatus requirements, requirements on services and installation
DIN EN 13060:2009 Small steam sterilizers; German version EN 13060:2004+A1:2009
DIN EN 13060:2010 Small steam sterilizers; German version EN 13060:2004+A2:2010
DIN 58951-2:2018-01 Sterilization - Steam sterilizers for laboratory use - Part 2: Apparatus requirements, requirements on services and installation
DIN EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014
DIN EN 868-8:2019 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
DIN EN 868-8:2019-03 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
DIN 58948-17:2016-10 Sterilization - Low temperature sterilizers - Part 17: Requirements for the installation and operation of low temperature steam formaldehyde and formaldehyde sterilizers and their supply sources
DIN EN ISO 11140-4:2007 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
DIN EN 14180:2010 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2003+A2:2009
DIN SPEC 58929:2012-08 Operation of small steam sterilizers in the health-care system - Guidance for validation and routine control of sterilization processes / Note: Applies in conjunction with DIN EN ISO 17665-1 (2006-11).
DIN EN ISO 11138-5:2017-07 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
DIN EN 17180:2023 Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2023
DIN EN 17180:2023-03 Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2023 / Note: Date of issue 2023-02-10
DIN SPEC 58929:2012 Operation of small steam sterilizers in the health-care system - Guidance for validation and routine control of sterilization processes
DIN EN ISO 11140-6:2023-02 Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing for small steam sterilizers (ISO 11140-6:2022); German version EN ISO 11140-6:2022
DIN EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices; English version of DIN EN 15424:2007-08
DIN EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006
DIN EN ISO 25424:2020 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)
DIN EN ISO 25424:2022-07 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 + Amd 1:2022); German version EN ISO 25424:2019...
DIN EN ISO 11140-6:2023 Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing for small steam sterilizers (ISO 11140-6:2022)
DIN EN ISO 11138-5 Berichtigung 1:2007 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006, Corrigenda to DIN EN ISO 11138-5:2006-

ES-UNE, Sterilization vapor testing

UNE-EN 285:2016+A1:2023 Sterilization - Steam sterilizers - Large sterilizers
UNE-EN 13060:2015+A1:2019 Small steam sterilizers
UNE-EN ISO 25424:2020 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)
UNE-EN ISO 11140-6:2023 Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)
UNE-EN ISO 25424:2020/A1:2022 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)

GOSTR, Sterilization vapor testing

GOST R EN 13060-2011 Small steam sterilizers
GOST R 58163-2018 Sterilization of health care products. Moist heat. Part 3. Guidance on the designation of a medical device to a product family and processing category for steam sterilization

Professional Standard - Medicine, Sterilization vapor testing

YY 1007-2010 Vertical mode steam sterilizers
YY 0504-2016 Portable Steam Sterilizer
YY 1007-2005 Vertical mode steam sterilizers
YY/T 0646-2022
YY 0504-2005 Portable mode steam sterilizers
YY 0085.2-1992 Forevacuum pressure steam sterilizer
YY 0679-2008 Sterilizers for medical purposes.Low temperature steam and formaldehyde sterilizers
YY 91111-1999 Series of horizontal autoclave sterilizers
YY 0085.1-1992 Pulse vacuum pressure steam sterilizer
YY 0646-2008 Small steam sterilizers.automatic type
YY/T 0159-2005 Steam trap fitted on pressure steam sterilizer
YY 0731-2009 Large steam sterilizers.Manual control type
YY/T 0646-2015 Small steam sterilizer automatic control type
YY/T 0157-2005 Spring type release on pressure steam sterilizer
YY/T 0158-2005 Spring type gasket on pressure steam sterilizer
YY/T 0158-2013 Gasket ring on pressure steam sterilizer
YY 1277-2016 Biosafety performance requirements for steam sterilizers
YY 0154-2005 Spring type safety valve on pressure steam sterilizer
YY 0154-1994 Spring-loaded safety valve for pressure steam sterilization equipment
YY 1277-2023 Biosafety performance requirements for pressure steam sterilizers
YY 0154-2013 Spring full lift safety valves on pressure steam sterilizer
YY/T 1464-2016 Sterilization of medical devices.Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices
YY/T 1402-2016 Test method to demonstrate the suitability of the process challenge device(PCD)during steam sterilization
YY/T 0698.8-2009 Packaging materials for terminally sterilized medical devices—Part 8: Requirements and test methods for reusable sterilization containers for steam sterilizers
YY/T 0084.1-1992 Major pressure component of round pressure and steam sterilizer Calculation of intension and related stipulations
YY/T 0084.1-2009 Strength calculation and relevant regulations of primary pressure components of cylindrical pressure steam sterilizer
YY/T 0084.2-2009 Strength calculation and relevant regulations of primary pressure containing parts for rectangular pressure steam-heated sterilizer
YY/T 0084.2-1992 Major pressure component of rectangle pressure and steam sterilizer Calculation of intension and related stipulations

US-AAMI, Sterilization vapor testing

ANSI/AAMI ST8-2013 Hospital steam sterilizers
ANSI/AAMI ST79 and A1 and A2 and A3-2012 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79 and A1 and A2 and A3 and A4-2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79-2010/A4-2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities,Amendment 4
ANSI/AAMI/ISO TIR17665-3:2014 Sterilization of health care products - Moist heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization

American National Standards Institute （ANSI), Sterilization vapor testing

ANSI/AAMI ST55:2016(R2023) Table-top steam sterilizers
ANSI/AAMI ST79/A 2.1-2011 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79/A 2.2-2011 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79/A 2.3-2011 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79/A 2.5-2011 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79/A 3.1-2012 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79/A 3.6-2012 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79/A 3.7-2012 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79/A 3.4-2012 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79/A 3.3-2012 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79-2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79/A 3.2-2012 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79/A 3.5-2012 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79/A 4.1-2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI ST79/A 4.2-2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ANSI/AAMI/ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration

Korean Agency for Technology and Standards (KATS), Sterilization vapor testing

KS P 6130-2020 Table-top steam sterilizers
KS P 6131-2020 Hospital steam sterilizers
KS P 6101-2017 Boiling and steam sterilizer
KS P 6102-2009(2019) High-pressure steam sterilizers for medical use
KS P ISO 11138-5:2009 Sterilization of health care products－Biological indicators－Part 5：Biological indicators for low-temperature steam and formaldehyde sterilization processes
KS P ISO 11138-5:2020 Sterilization of health care products — Biological indicators —Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
KS P ISO 25424:2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 11140-4:2020 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
KS P ISO 11140-4:2009 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

国家食品药品监督管理局, Sterilization vapor testing

YY/T 1007-2018 Vertical steam sterilizer
YY/T 1609-2018 Cassette steam sterilizer
YY/T 1612-2018 Test method for medical sterilization steam quality
YY/T 0679-2016 Medical low temperature steam formaldehyde sterilizer

工业和信息化部/国家能源局, Sterilization vapor testing

JB/T 20171-2016 Medical pure steam sterilizer

TH-TISI, Sterilization vapor testing

TIS 2665-2014 Small steam sterilizers for medical uses

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会, Sterilization vapor testing

GB/T 33420-2016 Evaluation standard of biological for moist heat sterilization processes

Professional Standard - Supply and Marketing Cooperative, Sterilization vapor testing

GH/T 1417-2023 Steam sterilizer for edible fungi culture medium

中华全国供销合作总社, Sterilization vapor testing

GH/T 1139-2017 "Steam sterilizer for edible fungi culture media"

ZA-SANS, Sterilization vapor testing

SANS 981:1973 High-pressure down-draught steam sterilizers (autoclaves) (with independent steam supply)
SANS 982:1990 High-pressure high-vacuum steam sterilizers (autoclaves)
SANS 982:2009 High-pressure high-vacuum steam sterilizers (autoclaves)

Japanese Industrial Standards Committee (JISC), Sterilization vapor testing

JIS T 7322:1989 High-pressure steam sterilizers for medical use
JIS T 7322:2005 High-pressure steam sterilizers for medical use
JIS T 7324:1989 High-pressure steam sterilizers for medical use (small size)
JIS T 7324:2005 High-pressure steam sterilizers for medical use (Small size)

Group Standards of the People's Republic of China, Sterilization vapor testing

T/ZZB 2396-2021 Micro tabletop type B steam sterilizers
T/WSJD 9-2020 Technical guidelines for on-line monitoring of sterilization effect of small pressure steam sterilizers in medical institutions
T/FDSA 023-2021 General technical criteria of instruction bags for formaldehyde sterilization
T/CASME 325-2023 Testing method for performance of moist heat sterilizer

国家医药管理局, Sterilization vapor testing

YY/T 0159-1994 Steam trap for pressure steam sterilization equipment
YY/T 0157-1994 Spring-type steam release valve for pressure steam sterilization equipment
YY/T 0158-1994 Sealing gaskets for pressure steam sterilization equipment

IN-BIS, Sterilization vapor testing

RU-GOST R, Sterilization vapor testing

GOST EN 14180-2011 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and tests
GOST 19569-1989 Medical steam sterilizers. General technical requirements and test methods

Professional Standard - Aquaculture, Sterilization vapor testing

SC/T 6024-2003 Sterilizing device using pressure steam for small package food

CEN - European Committee for Standardization, Sterilization vapor testing

EN 285:2015/PRA1:2018 Sterilization - Steam sterilizers - Large sterilizers
EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development@ validation and routine control of a sterilization process for medical devices

卫生健康委员会, Sterilization vapor testing

WS/T 649-2019 Hygiene requirements for medical low-temperature steam formaldehyde sterilizers
WS/T 651-2019 Evaluation requirements for medical low-temperature steam formaldehyde sterilization indicators

未注明发布机构, Sterilization vapor testing

BS EN 866-5:2000 Biological systems for testing sterilizers and sterilization processes - Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizers
BS 3970-6:1993(1999) Sterilizing and disinfecting equipment for medical products — Part 6 : Specification for sterilizers using low temperature steam with formaldehyde
BS EN ISO 25424:2018+A1:2022 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
BS 3970-2:1991(2011) Sterilizing and disinfecting equipment for medical products — Part 2 : Specification for steam sterilizers for aqueous fluids in sealed rigid containers
BS 3970-4:1990(1999) Sterilizing and disinfecting equipment for medical products — Part 4 : Specification for transportable steam sterilizers for unwrapped instruments and utensils
BS 3970-5:1990(2011) Sterilizing and disinfecting equipment for medical products — Part 5 : Specification for low temperature steam disinfectors
DIN EN ISO 25424:2022 Sterilization of healthcare products – Low temperature vapor formaldehyde – Requirements for the development, validation and routine monitoring of sterilization procedures for medical devices

RO-ASRO, Sterilization vapor testing

STAS 11359/10-1981 NATIVE SULPHUR ORES AND CONCENTRATES Acidity determination

Canadian Standards Association (CSA), Sterilization vapor testing

CSA Z314.7-M91-CAN/CSA-1991 Steam Sterilizers Used for Hospitals.General Instruction No 1
CSA Z314.7-2003 Stérilisateurs à la vapeur pour les établissements de santé (Quatrième édition; Mise à jour no 1: Décembre 2005)
CAN/CSA-Z314.7-2003 Steam Sterilizers for Health Care Facilities (Fourth Edition; Update No. 1: December 2005)

UNKNOWN, Sterilization vapor testing

GB/T 18281.5-2015 Biological Indicators for Sterilization of Healthcare Products Part 5: Biological Indicators for Formaldehyde Sterilization by Low Temperature Steam

International Organization for Standardization (ISO), Sterilization vapor testing

ISO/TS 17665-3:2013 Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
ISO/CD 11140-4 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 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 25424:2018/Amd 1:2022 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment
ISO 11140-6:2022 Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
ISO 11140-4:2007 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

KR-KS, Sterilization vapor testing

KS P ISO 11138-5-2020 Sterilization of health care products — Biological indicators —Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
KS P ISO 25424-2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 11140-4-2020 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

国家药监局, Sterilization vapor testing

YY/T 1464-2022 Development, validation and routine control requirements for low-temperature steam formaldehyde medical device sterilization process for sterilization of healthcare products

Xinjiang Provincial Standard of the People's Republic of China, Sterilization vapor testing

DB65/T 2203-2005 Methods and Standards to Evaluting the Efficacy of High.pressure Steam Sterilization at Altitude Above 2000m

North Atlantic Treaty Organization Standards Agency, Sterilization vapor testing

STANAG 2906-1998 ESSENTIAL PHYSICAL REQUIREMENTS AND PERFORMANCE CHARACTERISTICS OF FIELD TYPE HIGH PRESSURE STEAM STERILIZERS

Professional Standard - Agriculture, Sterilization vapor testing

JAP-082 Captan, ethyl ester fofol, chlorothalonil and folpet detection method

HU-MSZT, Sterilization vapor testing

MSZ 9402/34.lap-1961

AT-ON, Sterilization vapor testing

OENORM EN ISO 11140-6:2021 Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO/DIS 11140-6:2021)
OENORM EN ISO 25424/A1:2021 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/DAM 1:2021) (Amendment)

CZ-CSN, Sterilization vapor testing

CSN 37 8312-1979 Detection of combustible gases and vapours escape

NATO - North Atlantic Treaty Organization, Sterilization vapor testing

STANAG 2906-1983 Essential Physical Requirements and Performance Characteristics of Field Type High Pressure Steam Sterilizers (ED 2 AMD 2; To obtain please contact your national Defense Standardization Office or the NATO Standardization Office website: http:/ so.nato.int