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Sterilizer Validation System

Sterilizer Validation System, Total:290 items.

In the international standard classification, Sterilizer Validation System involves: Sterilization and disinfection, Microbiology, Protection against fire, Cans. Tins. Tubes, Electricity. Magnetism. Electrical and magnetic measurements, Metrology and measurement in general, Horology, Medical equipment, Nuclear energy engineering, Refrigerating technology, Linear and angular measurements.

European Committee for Standardization (CEN), Sterilizer Validation System

EN 554:1994 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat
EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
EN 866-3:1997 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 3: Particular Systems for Use in Moist Heat Sterilizers
EN 866-6:1999 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 6: Particular Systems for Use in Dry Heat Sterilizers
EN ISO 11737-2:2020 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)
EN 866-2:1997 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 2: Particular Systems for Use in Ethylene Oxide 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 ISO 11737-2:2000 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process ISO 11737-2: 1998
EN 552:1994/A1:1999 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation Includes Amendment A1:1999
EN 866-7:1999 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 7: Particular Requirements for Self-Contained Biological Indicator Systems for Use in Moist Heat Sterilizers
EN 866-8:1999 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 8: Particular Requirements for Self-Contained Biological Indicator Systems for Use in Ethylene Oxide Sterilizers
prEN ISO 17665 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022)
EN 866-1:1997 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 1: General Requirements
prEN ISO 11135 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023)
prEN ISO 11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)
EN 867-1:1997 Non-Biological Systems for Use in Sterilizers - Part 1: General Requirements
EN ISO 11137-1:2006/A1:2013 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)
EN ISO 11137-1:2015/A2:2019 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
EN 867-2:1997 Non-Biological Systems for Use in Sterilizers - Part 2: Process Indicators (Class A)
EN ISO 11137-1:2015 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, including Amd 1:2013)
EN 868-1:1997 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 1: General Requirements and Test Methods
EN 1174-3:1996 Sterilization of Medical Devices - Estimation of the Population of Micro-Organisms on Product - Part 3: Guide to the Methods for Validation of Microbiological Techniques
EN ISO 11607-1:2020/prA1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/DAM 1:2022)
EN ISO 14937:2009 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)
EN ISO 11607-2:2020/prA1 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022)
EN 12094-8:2006 Fixed firefighting systems - Components for gas extinguishing systems - Part 8: Requirements and test methods for connectors
EN 12094-8:1998 Fixed Firefighting Systems - Components for Gas Extinguishing Systems - Part 8: Requirements and Test Methods for Flexible Connectors for CO2 Systems

未注明发布机构, Sterilizer Validation System

BS EN 552:1994(2001) Sterilization of medical devices — Validation and routine control of sterilization by irradiation
BS EN 554:1994(1998) Sterilization ofmedical devices — Validation and routine control ofsterilization by moist heat
BS EN 550:1994(1998) Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization
BS EN 866-4:2000 Biological systems for testing sterilizers and sterilization processes - Part 4: Particular systems for use in irradiation sterilizers
BS EN 866-6:2000 Biological systems for testing sterilizers and sterilization processes - Part 6: Particular systems for use in dry heat sterilizers
BS EN 866-3:1997 Biological systems for testing sterilizers and sterilization processes Part 3. Particular systems for use in moist heat sterilizers
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 EN 866-7:2000 Biological systems for testing sterilizers and sterilization processes - Part 7: Particular requirements for self - contained biological indicator systems for use in moist heat sterilizers
BS EN 866-8:2000 Biological systems for testing sterilizers and sterilization processes - Part 8: Particular requirements for self - contained biological indicator systems for use in ethylene oxide sterilizers
BS EN ISO 11135:2014+A1:2019(2020) Sterilization of health - care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
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
BS EN 866-1:1997 Biological systems for testing sterilizers and sterilization processes Part 1. General requirements
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
DIN EN ISO 11607-1 Berichtigung 1:2016 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
DIN EN ISO 11607-1 A11:2022 Packaging for medical devices to be sterilized in the final packaging – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
DIN EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized — Part 1: General requirements and test methods
DIN EN ISO 11607-1:2017 Packaging for medical devices to be sterilized in the final packaging – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1.:2014); German version EN ISO 11607-1:2017

British Standards Institution (BSI), Sterilizer Validation System

BS EN 866-2:1998 Biological systems for testing sterilizers and sterilization processes - Particular systems for use in ethylene oxide sterilizers
BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
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
22/30409085 DC BS EN ISO 17665. Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS ISO 22441:2022 Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
23/30424625 DC BS EN ISO 11135. Sterilization of health care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
23/30426672 DC BS EN ISO 11137-1. Sterilization of health care products. Radiation - Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices
PD ISO/TS 21387:2020 Sterilization of medical devices. Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
17/30363659 DC BS EN ISO 11137-1 AMD2. Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices
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
18/30338923 DC 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
21/30412844 DC BS EN ISO 22441. Sterilization of health care products. Low temperature vaporized hydrogen peroxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN ISO 11607-2:2020+A11:2022 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
DD ISO/TS 13075:2009 Gaseous-media fire-extinguishing systems. Engineered extinguishing systems. Flow calculation implementation method and flow verification and testing for approval
22/30427344 DC BS EN ISO 11607-1:2019 AMD1. Packaging for terminally sterilized medical devices - Part 1. Requirements for materials, sterile barrier systems and packaging systems
BS EN ISO 14160:2021 Tracked Changes. 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 ...
22/30422020 DC BS ISO 11607-2:2019/AMD1. Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
18/30363974 DC BS EN ISO 14160. 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 ...
23/30437554 DC BS ISO 11040-7. Prefilled syringes - Part 7. Packaging systems for sterilized subassembled syringes ready for filling
BS EN 12094-8:2006 Fixed firefighting systems - Components for gas extinguishing systems - Requirements and test methods for connectors
BS EN ISO 14937:2010 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
BS EN ISO 14937:2009 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
BS 7516:1995 Nuclear instrumentation. Liquid-scintillation counting systems. Performance verification
BS EN ISO 11140-3:2010 Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
BS EN ISO 11140-3:2007 Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
BS EN ISO 11140-3:2009 Sterilization of health care products - Chemical indicators - Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
BS EN 12094-9:2003 Fixed firefighting systems - Components for gas extinguishing systems - Requirements and test methods for special fire detectors
BS EN 12094-4:2004 Fixed firefighting systems - Components for gas extinguishing systems - Requirements and test methods for container valve assemblies and their actuators

German Institute for Standardization, Sterilizer Validation System

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 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 17665:2022-11 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022); German and English version prEN ISO 17665:2022 / Note: Date of is...
DIN EN ISO 20857:2013-08 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
DIN EN ISO 11135:2020-04 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019
DIN EN ISO 17665-1:2006-11 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 / Note: To be replaced b...
DIN EN ISO 14937:2010-03 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); German version EN ISO 14937:2009
DIN EN ISO 11137-1:2020-04 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, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1...
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 11135:2023-05 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023 / Note: Date o...
DIN EN ISO 11137-1:2023-05 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023 / Note:...
DIN 58952-3:2012-04 Sterilization - Transport baskets for sterile barrier systems - Part 3: Instrument trays for sterilizing goods made of metal
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 14160:2018 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 pr
DIN EN ISO 14160:2021-11 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...
DIN EN ISO 11607-1/A11:2022-08 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/A11:2022
DIN EN ISO 11607-1:2020-05 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 / Note: To be amended by DIN EN ISO 11607-1/A1 (2022-08).
DIN EN ISO 11135:2020 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018) (includes Amendment :2019)
DIN 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 - Amendment 1 (ISO 25424:2018/DAM 1:2021); German and English vers
DIN EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
DIN EN ISO 11607-2:2020-05 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 / Note: To be amended by DIN EN ISO 11607-2/A1 (2022-08).
DIN EN ISO 11607-2/A11:2022-08 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/A11:2022
DIN EN ISO 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023
DIN EN ISO 11137-1:2023 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023); German and English version prEN ISO 11137-1:2023
DIN ISO 11040-7:2020-11 Prefilled syringes - Part 7: Packaging systems for sterilized subassembled syringes ready for filling (ISO 11040-7:2015)
DIN EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
DIN EN ISO 11607-1/A1:2022-08 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/DAM 1:2022); German and English version EN ISO 11607-1:2020/prA1:2022 / Note: Date o...
DIN EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO/DIS 11607-2:2017); German and English version prEN ISO 11607-2:2017
DIN EN 12094-8:2016 Fixed firefighting systems - Components for gas extinguishing systems - Part 8: Requirements and test methods for connectors; German and English version prEN 12094-8:2016
DIN EN ISO 11607-2/A1:2022-08 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022); German and English version EN ISO 11607-2:2020/prA1:2022 / Note: Date of issu...

International Organization for Standardization (ISO), Sterilizer Validation System

ISO/TS 13409:2002 Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
ISO/DIS 17665 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/FDIS 17665:2023 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/DIS 11135 Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/DIS 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11737-2:2019 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 14160:2020 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, developmen
ISO 22441:2022 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 21387:2020 Sterilization of medical devices — Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
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 11607-1:2019/FDAmd 1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
ISO 11607-2:2006/Amd 1:2014 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
ISO 11607-2:2019/FDAmd 1 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
ISO 11607-1:2019/Amd 1:2011 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management
ISO 14937:2009 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 11607-2:2019/Amd 1:2011 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
ISO/CD 6182-2:2023 Fire protection — Automatic sprinkler systems — Part 2: Requirements and test methods for sprinkler system alarm valves, check valves, water motor alarms, retard devices and accelerators

Association Francaise de Normalisation, Sterilizer Validation System

NF EN ISO 14937:2009 Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un agent stérilisant et pour la mise au point, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux
NF S98-101*NF EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
NF EN ISO 20857:2013 Stérilisation des produits de santé - Chaleur sèche - Exigences pour l'élaboration, la validation et le contrôle de routine d'un processus de stérilisation pour dispositifs médicaux
XP ISO/TS 21387:2020 Stérilisation des dispositifs médicaux - Lignes directrices concernant les exigences de validation et de traitement de routine des procédés de stérilisation à l'oxyde d'éthylène par libération paramétrique
NF EN ISO 17665-1:2006 Stérilisation des produits de santé - Chaleur humide - Partie 1 : exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation des dispositifs médicaux
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 EN ISO 11137-1:2016 Stérilisation des produits de santé - Irradiation - Partie 1 : exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux
NF EN ISO 11135:2014 Stérilisation des produits de santé - Oxyde d'éthylène - Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des 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 S98-103-1*NF EN ISO 11137-1:2016 Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices
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 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 S98-052-1*NF EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems
NF EN ISO 11607-1:2020 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1 : exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage
NF EN ISO 11137-1/A2:2019 Stérilisation des produits de santé - Irradiation - Partie 1 : exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux - Amendement 2 : révision de 4.3.4 e...
NF S98-101/A1*NF EN ISO 11135/A1:2019 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - AMENDMENT 1: Revision of Annex E, Single batch release
NF EN ISO 11607-1/A11:2022 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1 : exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage - Amendement A11
NF S98-052-2*NF EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes
NF EN ISO 11607-2:2020 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : exigences de validation pour les procédés de formage, scellage et assemblage
NF EN ISO 11135/A1:2019 Stérilisation des produits de santé - Oxyde d'éthylène - Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux - AMENDEMENT 1 : révision de l'Annexe E, Libération ...
NF ISO 11040-7:2015 Seringues préremplies - Partie 7 : système d'emballage pour les seringues stérilisées prêtes à l'emploi et préremplissables
NF S93-006-7*NF ISO 11040-7:2015 Prefilled syringes - Part 7 : packaging systems for sterilized subassembled syringes ready for filling
NF EN ISO 14160:2021 Stérilisation des produits de santé - Agents stérilisants chimiques liquides pour dispositifs médicaux non réutilisables utilisant des tissus animaux et leurs dérivés - Exigences pour la caractérisation, le développement, la validation et le c...
NF EN ISO 11607-2/A11:2022 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : exigences de validation pour les procédés de formage, scellage et assemblage - Amendement A11
NF S62-138*NF EN 12094-8:2006 Fixed firefighting system - Components for gas extinguishing systems - Part 8 : requirements and test methods for connectors
NF S62-134*NF EN 12094-4:2004 Fixed firefighting systems - Components for gas extinguishing systems - Part 4 : requirements and test methods for container valve assemblies and their actuators
NF S62-138:1998 Fixed firefighting system. Components for gas extinguishing systems. Part 8 : requirements and test methods for flexible connectors for CO2 systems.

CEN - European Committee for Standardization, Sterilizer Validation System

EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition@ validation and maintenance of a sterilization process
EN 552:1994 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation (Incorporates Amendment A1: 1999)
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

国家食品药品监督管理局, Sterilizer Validation System

YY/T 1608-2018 Sampling methods for radiation sterilization verification dose experiments and sterilization dose audits of medical devices

US-AAMI, Sterilizer Validation System

AAMI TIR56-2013 Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices

Danish Standards Foundation, Sterilizer Validation System

DS/EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 14937:2009 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
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 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 11737-2:2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
DS/EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 11137-1/A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
DS/ISO 14160:2021 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 pr
DS/EN ISO 14160:2021 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 pr
DS/EN 867-5:2001 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
DS/EN ISO 14160:2011 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 pr
DS/EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
DS/EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
DS/EN 12094-8/ZA:2007 Fixed firefighting systems – Components for gas extinguishing systems – Part 8: Requirements and test methods for connectors
DS/EN 12094-8:2006 Fixed firefighting systems – Components for gas extinguishing systems – Part 8: Requirements and test methods for connectors

KR-KS, Sterilizer Validation System

KS P ISO 11135-2022 Sterilization of health-care products ─ Ethylene oxide ─ Requirements for the development, validation and routine control of a sterilization process for medical devices
KS P ISO 14937-2018 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 devi
KS P ISO 11137-1-2022 Sterilization of health care products ─ Radiation ─ Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 11737-2-2018 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
KS P ISO 11137-1-2019 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 17665-1-2019 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
KS P ISO 11135-2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
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 11607-1-2021 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
KS P ISO 11607-1-2018 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
KS P ISO 11607-2-2021 Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
KS P ISO 11607-2-2018 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

RU-GOST R, Sterilizer Validation System

GOST ISO 11135-2017 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
GOST ISO 11737-2-2011 Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process
GOST 8.216-2011 State system for ensuring the uniformity of measurements. Voltage transformers. Verification procedure
GOST 8.216-1988 State system for ensuring the uniformity of measurements. Voltage transformers. Verification methods
GOST 8.286-1978 State system for ensuring the uniformity of measurements. Electrical timemeters. Methods and means for verification
GOST R 53288-2009 Automatic water and foam extinguishers systems. Automatic fire water mist spray extinguishers systems. Modules. General technical requirements. Test methods
GOST 8.311-1978 State system for ensuring the uniformity of measurements. Cathode-ray oscillographs. Methods and means for verification
GOST R 8.687-2009 State system for ensuring the uniformity of measurements. D. C. measuring voltage dividers. Verification methods
GOST 8.608-2012 State system for ensuring the uniformity of measurements. State verification schedule for measuring instruments of chromatic dispersion in optical fiber
GOST R 8.671-2009 State system for ensuring the uniformity of measurements. In process gauges of linear parameters. Verification methods

Canadian Standards Association (CSA), Sterilizer Validation System

CAN/CSA-ISO 14937:2011 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 (Second Edition)
CAN/CSA-Z11135-2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (First Edition)
CAN/CSA-Z11137-2007 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (First Edition)
CSA ISO 14937-01-CAN/CSA:2001-b 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 First Edition; ISO 14937:2000
CSA ISO 11607-1:2021 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (Adopted ISO 11607-1:2019, second edition, 2019-02)

Lithuanian Standards Office , Sterilizer Validation System

LST EN ISO 14937:2010 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)
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)
LST EN ISO 11137-1:2006 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)
LST EN ISO 17665-1:2006 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)
LST EN ISO 11737-2:2010 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)
LST EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
LST EN 867-5-2002 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
LST EN ISO 14160:2011 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 pr
LST EN ISO 14160:2021 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 pr
LST EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
LST EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

AENOR, Sterilizer Validation System

UNE-EN ISO 14937:2010 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)
UNE-EN ISO 11135:2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
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)
UNE-EN ISO 20857:2013 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)
UNE-EN ISO 17665-1:2007 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)
UNE-EN ISO 11737-2:2010 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)
UNE-EN 867-5:2002 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.
UNE-EN ISO 14160:2012 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 pr
UNE-EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
UNE-EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)

Korean Agency for Technology and Standards (KATS), Sterilizer Validation System

KS P ISO 14937:2018 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 devi
KS P ISO 11737-2:2018 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
KS P ISO 11137-1:2019 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 17665-1:2019 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
KS P ISO 11135:2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
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 11607-1:2021 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
KS P ISO 11607-1:2018 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
KS P ISO 11607-2:2021 Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
KS P ISO 11607-2:2018 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
KS B ISO 6182-1-2007(2017) Fire protection－Automatic sprinkler systems－Part 1：Requirements and test methods for sprinklers
KS B ISO 6182-1-2007(2022) Fire protection－Automatic sprinkler systems－Part 1：Requirements and test methods for sprinklers
KS B ISO 6182-10-2007(2022) Fire protection－Automatic sprinkler systems－Part 10：Requirements and test methods for domestic sprinklers
KS B ISO 6182-10-2007(2017) Fire protection－Automatic sprinkler systems－Part 10：Requirements and test methods for domestic sprinklers
KS P ISO 14937:2012 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

NZ-SNZ, Sterilizer Validation System

AS/NZS ISO 11137-1:2006 Sterilization of health care products- Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

ES-UNE, Sterilizer Validation System

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 11137-1:2015 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, including Amd 1:2013)
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)
UNE-EN ISO 14160:2021 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...
UNE-EN ISO 11607-1:2020/A11:2022 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
UNE-EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
UNE-EN ISO 11137-1:2015/A2:2020 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
UNE-EN ISO 11135:2015/A1:2020 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
UNE-EN ISO 11607-2:2020/A11:2022 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
UNE-EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
ISO/DIS 11040-7:2023 Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling

Professional Standard - Medicine, Sterilizer Validation System

YY/T 0698.6-2009 Packaging materials for terminally sterilized medical devices-Part 6: Requirements and test methods for paper used in the production of sterile barrier systems for low-temperature sterilization processes or radiation sterilization
YY/T 0698.7-2009 Packing materials for terminal sterilized medical devices.Part 7:Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation.Requirements and test methods

American National Standards Institute （ANSI), Sterilizer Validation System

ISO/DIS 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI TIR39:2009(R2022) Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
ANSI/AAMI/ISO 14160:2011 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 pr
ANSI/ESD SP14.1-20041-2004 System Level Electrostatic Discharge (ESD) Simulator Verification Standard
ANSI/ESD SP14.1-2004 System Level Electrostatic Discharge (ESD) Simulator Verification Standard
ANSI/AAMI/ISO 11607-1:2006 Packaging for teminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging

TH-TISI, Sterilizer Validation System

TIS 2612.1-2013 Sterilization of heal th care products-ethylene oxide part 1:requirements for development,validation and routine control of a sterilization process for medical devices

Japanese Industrial Standards Committee (JISC), Sterilizer Validation System

JIS T 0806-1:2022 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Sterilizer Validation System

GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
GB/Z 34603-2017 Gaseous-media fire-extinguishing systems—Engineered extinguishing systems—Flow calculation implementation method and flow verification and testing for approval
GB 795-1989 Halon fire extinguishing systems performance requirements and method of test for container valves
GB 14105-1993 Halon fire extinguishing systems performance requirements and test methods for valve actuators

PT-IPQ, Sterilizer Validation System

NP EN ISO 14160:2000 Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants(ISO 14160-1998)

AT-ON, Sterilizer Validation System

OENORM EN ISO 14160:2021 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 pr
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)

CH-SNV, Sterilizer Validation System

SN EN ISO 14160:2021 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 pr

IT-UNI, Sterilizer Validation System

UNI EN ISO 14160:2021 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 pr

VN-TCVN, Sterilizer Validation System

TCVN 7394-1-2008 Packaging for terminally sterilized medical devices.Part 1: Requirements for materials, sterile barrier systems and packaging systems

GOSTR, Sterilizer Validation System

GOST ISO 11607-1-2018 Packaging for terminally sterilized medical devices. Part 1. Requirements for materials, sterile barrier systems and packaging systems
GOST ISO 11607-2-2018 Packaging for terminally sterilized medical devices. Part 2. Validation requirements for forming, sealing and assembly processes

CN-GJB-H, Sterilizer Validation System

GJB 5515/7-2006 Detail specification for sterilization shelter of medical meterials of field mobile medical system

ZA-SANS, Sterilizer Validation System

SANS 50868-8:2003 Packaging materials and systems for medical devices which are to be sterilized Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

Professional Standard - Commodity Inspection, Sterilizer Validation System

SN/T 3062.4-2011 Pachaking materials for terminally sterilized medical devices for import.Part 4:Requirements for materials and sterile barrier systems of importing medical device sterilization packaging

PL-PKN, Sterilizer Validation System

PN-EN ISO 11607-1-2020-06 P Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
PN-EN ISO 11135-2014-08/A1-2020-04 P Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices -- Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018
PN-EN ISO 11607-2-2020-06 P Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

Professional Standard - Agriculture, Sterilizer Validation System

348药典四部-2020 9000 Guidelines 9206 Guidelines for the Validation of Isolation Systems for Sterility Testing
329药典四部-2015 9000 Guidelines 9206 Guidelines for the Validation of Isolation Systems for Sterility Testing
887兽药典一部-2015 Appendix Contents 9000 Guidelines 9206 Guidelines for Validation of Isolation Systems for Sterility Testing

Standard Association of Australia （SAA）, Sterilizer Validation System

ISO 11607-1:2019/Amd 1:2023 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — AMENDMENT 1: Application of risk management
ISO 11607-2:2019/Amd 1:2023 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — AMENDMENT 1: Application of risk management

Indonesia Standards, Sterilizer Validation System

SNI 18-7027-2004 Nuclear instrumentation - Liquid scintillation counting systems - Performance verification

International Electrotechnical Commission (IEC), Sterilizer Validation System

IEC 61304:1994 Nuclear instrumentation - Liquid-scintillation counting systems - Performance verification

CU-NC, Sterilizer Validation System

NC 90-15-36-1988 Standards System for Metrological Assurance. PE-11 Tester. Methods and Means of Verification

Professional Standard - Aerospace, Sterilizer Validation System

QJ 1177.10-1987 Environmental test methods for ground-to-air and ship-to-air missile weapon systems Mold test

GB-REG, Sterilizer Validation System

REG NASA-LLIS-0595-1998 Lessons Learned ?Misapplication of Heritage Systems, Subsystems and Validation Tools on the Lewis Spacecraft

Professional Standard - Public Safety Standards, Sterilizer Validation System

GA 80-1994 Performance requirements and test methods for sprinkler system accelerators
GA 32-1992 Performance requirements and test methods for sprinkler system water flow indicators

U.S. Military Regulations and Norms, Sterilizer Validation System

ARMY ADS-65-HDBK-2004 AIRWORTHINESS QUALIFICATION AND VERIFICATION GUIDANCE FOR ELECTRO-OPTICAL AND SENSOR SYSTEMS

ESD - ESD ASSOCIATION, Sterilizer Validation System

SP14.1-2004 System Level Electrostatic Discharge (ESD) Simulator Verification Standard Practice

Society of Automotive Engineers (SAE), Sterilizer Validation System

SAE ARP6539-2022 Validation and Verification Process Steps for Monitors Development in Complex Flight Control and Related Systems

SAE - SAE International, Sterilizer Validation System

SAE ARP6539-2017 Validation and Verification Process Steps for Monitors Development in Complex Flight Control and Related Systems

American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), Sterilizer Validation System

ASHRAE 4739-2004 Verification of a Neural Network-Based Controller for Commercial Ice Storage Systems

国家药监局, Sterilizer Validation System

YY/T 0681.15-2019 Test methods for sterile medical device packaging - Part 15: Performance testing of transport containers and systems